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Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00688870
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : May 12, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Vaccines
Pneumococcal Conjugate Vaccine
Interventions Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
Enrollment 168
Recruitment Details Subjects were recruited in Taiwan from June 2008 to Nov 2009
Pre-assignment Details A total of 169 subjects were screened, 168 subjects were randomly assigned in a 1:1 ratio to either the 13vPnC group (n=84) or the 7vPnC group (n=84).
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Period Title: Infant Series
Started 84 84
Vaccinated Dose 1 83 84
Vaccinated Dose 2 80 84
Vaccinated Dose 3 80 84
Completed 80 84
Not Completed 4 0
Reason Not Completed
Parent or legal guardian request             4             0
Period Title: After Infant Series
Started 80 84
Completed 80 84
Not Completed 0 0
Period Title: Toddler Dose
Started 80 84
Completed 80 84
Not Completed 0 0
Arm/Group Title 13vPnC 7vPnC Total
Hide Arm/Group Description Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. Total of all reporting groups
Overall Number of Baseline Participants 84 84 168
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 84 participants 84 participants 168 participants
2.2  (0.3) 2.3  (0.3) 2.2  (0.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 84 participants 168 participants
Female
40
  47.6%
47
  56.0%
87
  51.8%
Male
44
  52.4%
37
  44.0%
81
  48.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 84 participants 84 participants 168 participants
84 84 168
1.Primary Outcome
Title Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series.
Hide Description Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame 1 month after the infant series (7 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 83
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4
98.8
(93.2 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 6B
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 9V
98.8
(93.2 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 14
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 18C
100.0
(95.5 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 19F
98.8
(93.2 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 23F
95.0
(87.7 to 98.6)
100.0
(95.7 to 100.0)
Additional Serotypes - Serotype 1
98.8
(93.2 to 100.0)
2.4
(0.3 to 8.4)
Additional Serotypes - Serotype 3
97.5
(91.3 to 99.7)
2.4
(0.3 to 8.4)
Additional Serotypes - Serotype 5
98.8
(93.2 to 100.0)
61.5
(49.8 to 72.3)
Additional Serotypes - Serotype 6A
100.0
(95.5 to 100.0)
77.1
(66.6 to 85.6)
Additional Serotypes - Serotype 7F
100.0
(95.5 to 100.0)
2.4
(0.3 to 8.4)
Additional Serotypes - Serotype 19A
100.0
(95.5 to 100.0)
100.0
(95.6 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 4
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-6.8 to 3.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 6B
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 9V
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-6.8 to 3.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 14
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 18C
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 19F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-6.8 to 3.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 23F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -5.0
Confidence Interval (2-Sided) 95%
-12.3 to -0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 96.3
Confidence Interval (2-Sided) 95%
89.4 to 99.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 3
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 95.1
Confidence Interval (2-Sided) 95%
87.7 to 98.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 5
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 37.2
Confidence Interval (2-Sided) 95%
26.2 to 48.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 6A
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 22.9
Confidence Interval (2-Sided) 95%
14.4 to 33.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 7F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 97.6
Confidence Interval (2-Sided) 95%
91.6 to 99.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 19A
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose
Hide Description Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame 1 month after toddler dose (16 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population: had treatments as randomized at all 4 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 79 84
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Common Serotypes - Serotype 4
98.7
(93.1 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 6B
100.0
(95.4 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 9V
98.7
(93.1 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 14
100.0
(95.4 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 18C
100.0
(95.4 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 19F
98.7
(93.1 to 100.0)
100.0
(95.7 to 100.0)
Common Serotypes - Serotype 23F
100.0
(95.4 to 100.0)
100.0
(95.7 to 100.0)
Additional Serotypes - Serotype 1
100.0
(95.4 to 100.0)
5.0
(1.4 to 12.3)
Additional Serotypes - Serotype 3
96.2
(89.3 to 99.2)
13.8
(7.1 to 23.3)
Additional Serotypes - Serotype 5
100.0
(95.4 to 100.0)
90.4
(81.9 to 95.7)
Additional Serotypes - Serotype 6A
100.0
(95.4 to 100.0)
100.0
(95.7 to 100.0)
Additional Serotypes - Serotype 7F
100.0
(95.4 to 100.0)
6.3
(2.1 to 14.0)
Additional Serotypes - Serotype 19A
100.0
(95.4 to 100.0)
98.8
(93.5 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 4
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-6.9 to 3.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 6B
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 9V
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-6.9 to 3.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 14
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 18C
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 19F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-6.9 to 3.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 23F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 1
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 95.0
Confidence Interval (2-Sided) 95%
87.7 to 98.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 3
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 82.5
Confidence Interval (2-Sided) 95%
72.0 to 90.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 5
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 9.6
Confidence Interval (2-Sided) 95%
3.8 to 18.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 6A
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.6 to 4.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 7F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 93.8
Confidence Interval (2-Sided) 95%
86.0 to 97.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 19A
Type of Statistical Test Non-Inferiority or Equivalence
Comments Exact, unconditional, 2-sided 95% CI for the difference in proportions were computed using the noninferiority procedure of Chan and Zhang, using the standardized test statistics and gamma=0.000001.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chan and Zhang
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-3.4 to 6.5
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Infant Series
Hide Description Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame 1 month after the 3-dose infant series (7 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 83
Geometric Mean (95% Confidence Interval)
Unit of Measure: GMC mcg/mL
Common serotypes - serotype 4
2.89
(2.45 to 3.42)
4.64
(4.00 to 5.37)
Common serotypes - serotype 6B
4.37
(3.58 to 5.33)
4.82
(4.09 to 5.67)
Common serotypes - serotype 9V
1.97
(1.70 to 2.27)
2.92
(2.55 to 3.34)
Common serotypes - serotype 14
9.76
(8.34 to 11.43)
11.59
(9.79 to 13.71)
Common serotypes - serotype 18C
2.39
(2.04 to 2.82)
3.07
(2.64 to 3.56)
Common serotypes - serotype 19F
3.60
(3.00 to 4.32)
4.77
(4.17 to 5.47)
Common serotypes - serotype 23F
1.93
(1.56 to 2.37)
3.25
(2.78 to 3.80)
Additional serotypes - serotype 1
4.14
(3.45 to 4.96)
0.02
(0.02 to 0.02)
Additional serotypes - serotype 3
1.20
(1.00 to 1.45)
0.05
(0.04 to 0.06)
Additional serotypes - serotype 5
2.47
(2.09 to 2.92)
0.43
(0.35 to 0.53)
Additional serotypes - serotype 6A
4.57
(3.92 to 5.34)
0.79
(0.63 to 0.99)
Additional serotypes - serotype 7F
3.67
(3.14 to 4.29)
0.04
(0.03 to 0.05)
Additional serotypes - serotype 19A
3.69
(3.20 to 4.24)
2.46
(2.13 to 2.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.50 to 0.78
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 6B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.70 to 1.17
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 9V
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.55 to 0.82
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.67 to 1.06
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 18C
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.63 to 0.97
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 19F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.60 to 0.94
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 23F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.46 to 0.77
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 202.58
Confidence Interval (2-Sided) 95%
157.04 to 261.32
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 24.11
Confidence Interval (2-Sided) 95%
18.46 to 31.49
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 5.69
Confidence Interval (2-Sided) 95%
4.37 to 7.41
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 6A
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 5.82
Confidence Interval (2-Sided) 95%
4.42 to 7.67
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 7F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 96.10
Confidence Interval (2-Sided) 95%
75.60 to 122.17
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 19A
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
1.23 to 1.83
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
4.Other Pre-specified Outcome
Title GMC for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody, 1 Month After the Toddler Dose
Hide Description Antibody GMC as measured in mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.
Time Frame 1 month after the toddler dose (16 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable immunogenicity population: had treatments as randomized at all 3 doses, blood drawn within specified timeframes, had at least 1 valid and determinate assay result for the proposed analysis, and no major protocol violations.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 79 84
Geometric Mean (95% Confidence Interval)
Unit of Measure: GMC mcg/mL
Common serotypes - serotype 4
4.06
(3.34 to 4.93)
6.34
(5.26 to 7.65)
Common serotypes - serotype 6B
13.62
(11.08 to 16.73)
13.28
(10.87 to 16.21)
Common serotypes - serotype 9V
3.18
(2.66 to 3.80)
3.88
(3.27 to 4.60)
Common serotypes - serotype 14
8.17
(6.53 to 10.22)
12.04
(9.90 to 14.63)
Common serotypes - serotype 18C
3.67
(3.00 to 4.49)
4.87
(4.01 to 5.90)
Common serotypes - serotype 19F
8.07
(6.58 to 9.90)
7.41
(6.16 to 8.92)
Common serotypes - serotype 23F
5.51
(4.46 to 6.81)
7.97
(6.55 to 9.68)
Additional serotypes - serotype 1
7.62
(6.30 to 9.21)
0.03
(0.02 to 0.03)
Additional serotypes - serotype 3
1.29
(1.09 to 1.53)
0.12
(0.09 to 0.16)
Additional serotypes - serotype 5
4.57
(3.87 to 5.39)
0.95
(0.80 to 1.13)
Additional serotypes - serotype 6A
11.55
(9.66 to 13.81)
3.79
(3.01 to 4.76)
Additional serotypes - serotype 7F
5.91
(4.95 to 7.06)
0.06
(0.04 to 0.07)
Additional serotypes - serotype 19A
8.82
(7.45 to 10.43)
1.98
(1.69 to 2.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMC
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.49 to 0.84
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 6B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.77 to 1.36
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 9V
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.64 to 1.05
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.51 to 0.91
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.57 to 0.99
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 19F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.83 to 1.43
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Common serotypes - serotype 23F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 0.69
Confidence Interval (2-Sided) 95%
0.52 to 0.92
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 303.73
Confidence Interval (2-Sided) 95%
213.63 to 431.83
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 10.65
Confidence Interval (2-Sided) 95%
7.77 to 14.62
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 4.79
Confidence Interval (2-Sided) 95%
3.78 to 6.08
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 6A
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 3.05
Confidence Interval (2-Sided) 95%
2.28 to 4.08
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 7F
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 105.00
Confidence Interval (2-Sided) 95%
75.60 to 145.84
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Additional serotypes - serotype 19A
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter ratio of GMCs
Estimated Value 4.45
Confidence Interval (2-Sided) 95%
3.54 to 5.60
Estimation Comments Confidence intervals for the ratio are back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC-7vPnC reference).
5.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age).
Hide Description Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after Dose 1 of the infant series (2 Months of Age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 83 84
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness - Any 31.3 34.2
Tenderness - Significant 5.3 9.3
Swelling - Any 25.6 11.8
Swelling - Mild 24.4 11.8
Swelling - Moderate (n=74,74) 1.4 0.0
Swelling - Severe (n=74,74) 0.0 0.0
Redness - Any 29.9 28.9
Redness - Mild 26.0 26.3
Redness - Moderate (n=74,74) 8.1 2.7
Redness - Severe (n=74,74) 0.0 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tenderness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.735
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tenderness - Significant, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.533
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Moderate, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Swelling - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe swelling in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Moderate, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.275
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Redness - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe redness in either treatment group.
Method Fisher Exact
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)
Hide Description Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 Days after Dose 2 of the infant series (4 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 84
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness - Any 23.6 22.4
Tenderness - Significant (n=69,71) 2.9 1.4
Swelling - Any (n=70,72) 12.9 15.3
Swelling - Mild (n=70,72) 12.9 15.3
Swelling - Moderate (n=69,71) 0.0 0.0
Swelling - Severe (n=69,71) 0.0 0.0
Redness - Any (n=70,74) 17.1 20.3
Redness - Mild (n=70,74) 17.1 17.6
Redness - Moderate (n=69,71) 0.0 2.8
Redness - Severe (n=69,71) 0.0 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tenderness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tenderness - Significant, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.617
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.810
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.810
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Swelling - Moderate
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with moderate swelling in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Swelling - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe swelling in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.674
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Moderate, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.497
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Redness - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe redness in either treatment group.
Method Fisher Exact
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)
Hide Description Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after Dose 3 of the infant series (6 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 84
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness - Any (n=67,67) 19.4 17.9
Tenderness - Significant (n=65,65) 0.0 1.5
Swelling - Any (n=65,65) 16.9 4.6
Swelling - Mild (n=65,65) 15.4 4.6
Swelling - Moderate (n=65,64) 3.1 0.0
Swelling - Severe (n=65,64) 0.0 0.0
Redness - Any (n=67,65) 20.9 13.8
Redness - Mild (n=66,65) 18.2 13.8
Redness - Moderate (n=66,64) 4.5 0.0
Redness - Severe (n=65,64) 0.0 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tenderness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tenderness - Significant, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Moderate, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Swelling - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe swelling in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Moderate, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Redness - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe redness in either treatment group.
Method Fisher Exact
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Local Reactions: Toddler Dose (15 Months of Age).
Hide Description Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling and redness present); Mild (0.5 to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category.
Time Frame Within 4 days after the toddler dose (15 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 84
Measure Type: Number
Unit of Measure: percentage of participants
Tenderness - Any (n=64,75) 10.9 22.7
Tenderness - Significant (n=63,69) 0.0 0.0
Swelling - Any (n=63,70) 7.9 5.7
Swelling - Mild (n=63,70) 6.3 5.7
Swelling - Moderate (n=63,69) 1.6 0.0
Swelling - Severe (n=63,69) 0.0 0.0
Redness - Any (n=65,70) 15.4 12.9
Redness - Mild (n=65,70) 13.8 12.9
Redness - Moderate (n=63,69) 1.6 0.0
Redness - Severe (n=63,69) 0.0 0.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Tenderness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Tenderness - Significant
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with significant tenderness in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.735
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Swelling - Moderate, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.477
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Swelling - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe swelling in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Any, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Mild, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Redness - Moderate, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.477
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Redness - Severe
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with severe redness in either treatment group.
Method Fisher Exact
Comments [Not Specified]
9.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)
Hide Description Systemic events (any fever >=38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after Dose 1 of the infant series (2 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received dose 1 of the infant series vaccination (2 months of age). (n)= number of participants reporting yes for at least 1 day or no for all days.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 83 84
Measure Type: Number
Unit of Measure: percentage of participants
Fever >=38 but <=39 degrees C 55.0 50.0
Fever >39 but <=40 degrees C (n=74,74) 1.4 1.4
Fever >40 degrees C (n=74,74) 0.0 0.0
Decreased appetite 50.0 55.6
Irritability 65.0 70.0
Increased sleep 53.2 50.6
Decreased sleep 44.3 41.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.633
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Fever >40 degrees C
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with fever >40 degrees C in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased appetite, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.527
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Irritability, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.613
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Increased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.753
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.748
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)
Hide Description Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after Dose 2 of the infant series (4 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received the first 2 doses of the infant series vaccination (4 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 84
Measure Type: Number
Unit of Measure: percentage of participants
Fever >=38 but <=39 degrees C 52.1 43.4
Fever >39 but <=40 degrees C (n=69, 72) 2.9 2.8
Fever >40 degrees C (n=69, 71) 0.0 0.0
Decreased appetite 50.7 56.1
Irritability 56.0 57.5
Increased sleep 41.1 43.4
Decreased sleep (n=71, 77) 42.3 32.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.327
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Fever >40 degrees C
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with Fever >40 degrees C in either group
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased appetite, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.522
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Irritability, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.872
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Increased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.868
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.237
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)
Hide Description Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after dose 3 of the infant series (6 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received all 3 doses of the infant series vaccination (6 months of age). n=number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 84
Measure Type: Number
Unit of Measure: percentage of participants
Fever >=38 but <=39 degrees C (n=66,66) 31.8 22.7
Fever >39 but <=40 degrees C (n=65,66) 4.6 9.1
Fever >40 degrees C (n=65,64) 0.0 1.6
Decreased appetite (n=69,75) 43.5 52.0
Irritability (n=68,71) 42.6 47.9
Increased sleep (n=66,70) 40.9 37.1
Decreased sleep (n=68,69) 30.9 33.3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.329
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.492
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >40 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.496
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased appetite, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.322
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Irritability, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.610
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Increased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.726
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.855
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
12.Other Pre-specified Outcome
Title Percentage of Participants With Pre-specified Systemic Events: Toddler Dose (15 Months of Age).
Hide Description Systemic events (any fever >=38 degrees C, decreased appetite, irritability, increased sleep, decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.
Time Frame Within 4 days after the toddler dose (15 months of age)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all participants who received the toddler dose (15 months of age). n= number of participants reporting yes for at least 1 day or no for all days for each treatment group respectively.
Arm/Group Title 13vPnC 7vPnC
Hide Arm/Group Description:
Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series) and 15 months of age (toddler dose). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine.
Overall Number of Participants Analyzed 80 84
Measure Type: Number
Unit of Measure: percentage of participants
Fever >=38 but <=39 degrees C (n=65,70) 29.2 21.4
Fever >39 but <=40 degrees C (n=63,69) 3.2 4.3
Fever >40 degrees C (n=63,69) 0.0 0.0
Decreased appetite (n=65,75) 27.7 30.7
Irritability (n=65,74) 27.7 27.0
Increased sleep (n=66,72) 16.7 16.7
Decreased sleep (n=64,74) 17.2 23.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >=38 but <=39 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.326
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Fever >39 but <=40 degrees C, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments Fever >40 degrees C
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The p-value was not evaluated as there were no participant with Fever >40 degrees C in either treatment group.
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased appetite, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.714
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Irritability, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Increased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 13vPnC, 7vPnC
Comments For Decreased sleep, Fisher exact test was used to calculate p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Baseline through 1 month after last study vaccination (16 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=15 months of age.
Adverse Event Reporting Description An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event
 
Arm/Group Title Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Hide Arm/Group Description Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 13vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 2, 4 and 6 months of age (infant series). At 2 and 4 months of age during the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, and acellular pertussis (DTaP); inactivated poliovirus (IPV); and H influenzae type b (Hib). At 6 months of age during the infant series, 7vPnC was co-administered with DTaP-IPV-Hib and hepatitis B virus (HBV) vaccine. Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 15 months of age (toddler dose). Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 15 months of age (toddler dose).
All-Cause Mortality
Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/83 (4.82%)   4/84 (4.76%)   12/83 (14.46%)   9/84 (10.71%)   0/80 (0.00%)   3/84 (3.57%) 
Gastrointestinal disorders             
Ileus * 1  1/83 (1.20%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Inguinal hernia * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Intestinal functional disorder * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Tongue disorder * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Infections and infestations             
Gastroenteritis * 1  0/83 (0.00%)  3/84 (3.57%)  2/83 (2.41%)  0/84 (0.00%)  0/80 (0.00%)  1/84 (1.19%) 
Bronchopneumonia * 1  1/83 (1.20%)  1/84 (1.19%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Bronchiolitis * 1  1/83 (1.20%)  0/84 (0.00%)  2/83 (2.41%)  2/84 (2.38%)  0/80 (0.00%)  0/84 (0.00%) 
Escherichia urinary tract infection * 1  1/83 (1.20%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Pneumonia primary atypical * 1  1/83 (1.20%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Upper respiratory tract infection * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Urinary tract infection * 1  0/83 (0.00%)  1/84 (1.19%)  1/83 (1.20%)  3/84 (3.57%)  0/80 (0.00%)  0/84 (0.00%) 
Croup infectious * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Otitis media acute * 1  0/83 (0.00%)  0/84 (0.00%)  2/83 (2.41%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Pharyngitis * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Roseola * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Acute tonsillitis * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Cellulitis * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Gastroenteritis rotavirus * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Herpangina * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Pneumonia * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  1/84 (1.19%) 
Sinusitis * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Exanthema subitum * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  1/84 (1.19%) 
Metabolism and nutrition disorders             
Dehydration * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Hypovolaemia * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Nervous system disorders             
Febrile convulsion * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  2/84 (2.38%)  0/80 (0.00%)  0/84 (0.00%) 
Renal and urinary disorders             
Hydronephrosis * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Nephritis * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Reproductive system and breast disorders             
Testicular retraction * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Infant Series 13vPnC Infant Series 7vPnC After the Infant Series 13vPnC After the Infant Series 7vPnC Toddler Dose 13vPnC Toddler Dose 7vPnC
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   60/83 (72.29%)   67/84 (79.76%)   11/83 (13.25%)   16/84 (19.05%)   21/80 (26.25%)   23/84 (27.38%) 
Congenital, familial and genetic disorders             
Dacryostenosis congenital * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Eye disorders             
Dacryostenosis acquired * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Conjunctivitis * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  1/80 (1.25%)  0/84 (0.00%) 
Gastrointestinal disorders             
Colitis * 1  1/83 (1.20%)  2/84 (2.38%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Constipation * 1  2/83 (2.41%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  1/84 (1.19%) 
Enteritis * 1  1/83 (1.20%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Eructation * 1  2/83 (2.41%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Flatulence * 1  2/83 (2.41%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Irritable bowel syndrome * 1  2/83 (2.41%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Vomiting * 1  0/83 (0.00%)  2/84 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Abdominal distension * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Diarrhoea * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Gastrooesophageal reflux disease * 1  1/83 (1.20%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Haematochezia * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Mouth ulceration * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Gastric disorder * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Gastrointestinal disorder * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  1/80 (1.25%)  0/84 (0.00%) 
Intestinal functional disorder * 1  0/83 (0.00%)  0/84 (0.00%)  1/83 (1.20%)  0/84 (0.00%)  0/80 (0.00%)  1/84 (1.19%) 
Oesophagitis * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Peptic ulcer * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Stomatitis * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
General disorders             
Fever ≥ 38 degrees C but ≤ 39 degrees C  1 [1]  44/80 (55.00%)  39/78 (50.00%)  0/0  0/0  19/65 (29.23%)  15/70 (21.43%) 
Fever ≥ 38 degrees C but ≤ 39 degrees C  1 [2]  38/73 (52.05%)  33/76 (43.42%)  0/0  0/0  0/0  0/0 
Fever ≥ 38 degrees C but ≤ 39 degrees C  1 [3]  21/66 (31.82%)  15/66 (22.73%)  0/0  0/0  0/0  0/0 
Fever > 39 degrees C but ≤ 40 degrees C  1 [4]  1/74 (1.35%)  1/74 (1.35%)  0/0  0/0  2/63 (3.17%)  3/69 (4.35%) 
Fever > 39 degrees C but ≤ 40 degrees C  1 [5]  2/69 (2.90%)  2/72 (2.78%)  0/0  0/0  0/0  0/0 
Fever > 39 degrees C but ≤ 40 degrees C  1 [6]  3/65 (4.62%)  6/66 (9.09%)  0/0  0/0  0/0  0/0 
Fever > 40 degrees C  1 [7]  0/74 (0.00%)  0/74 (0.00%)  0/0  0/0  0/63 (0.00%)  0/69 (0.00%) 
Fever > 40 degrees C  1 [8]  0/69 (0.00%)  0/71 (0.00%)  0/0  0/0  0/0  0/0 
Fever > 40 degrees C  1 [9]  0/65 (0.00%)  1/64 (1.56%)  0/0  0/0  0/0  0/0 
Decreased appetite  1 [10]  39/78 (50.00%)  45/81 (55.56%)  0/0  0/0  18/65 (27.69%)  23/75 (30.67%) 
Decreased appetite  1 [11]  37/73 (50.68%)  46/82 (56.10%)  0/0  0/0  0/0  0/0 
Decreased appetite  1 [12]  30/69 (43.48%)  39/75 (52.00%)  0/0  0/0  0/0  0/0 
Irritability  1 [13]  52/80 (65.00%)  56/80 (70.00%)  0/0  0/0  18/65 (27.69%)  20/74 (27.03%) 
Irritability  1 [14]  42/75 (56.00%)  46/80 (57.50%)  0/0  0/0  0/0  0/0 
Irritability  1 [15]  29/68 (42.65%)  34/71 (47.89%)  0/0  0/0  0/0  0/0 
Increased sleep  1 [16]  41/77 (53.25%)  41/81 (50.62%)  0/0  0/0  11/66 (16.67%)  12/72 (16.67%) 
Increased sleep  1 [17]  30/73 (41.10%)  33/76 (43.42%)  0/0  0/0  0/0  0/0 
Increased sleep  1 [18]  27/66 (40.91%)  26/70 (37.14%)  0/0  0/0  0/0  0/0 
Decreased sleep  1 [19]  35/79 (44.30%)  32/78 (41.03%)  0/0  0/0  11/64 (17.19%)  17/74 (22.97%) 
Decreased sleep  1 [20]  30/71 (42.25%)  25/77 (32.47%)  0/0  0/0  0/0  0/0 
Decreased sleep  1 [21]  21/68 (30.88%)  23/69 (33.33%)  0/0  0/0  0/0  0/0 
Pyrexia * 1  5/83 (6.02%)  2/84 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  2/80 (2.50%)  2/84 (2.38%) 
Hepatobiliary disorders             
Jaundice * 1  0/83 (0.00%)  0/84 (0.00%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Immune system disorders             
Milk allergy * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Infections and infestations             
Upper respiratory tract infection * 1  31/83 (37.35%)  53/84 (63.10%)  0/83 (0.00%)  0/84 (0.00%)  9/80 (11.25%)  8/84 (9.52%) 
Bronchiolitis * 1  4/83 (4.82%)  4/84 (4.76%)  0/83 (0.00%)  1/84 (1.19%)  1/80 (1.25%)  0/84 (0.00%) 
Bronchitis * 1  7/83 (8.43%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  1/80 (1.25%)  0/84 (0.00%) 
Gastroenteritis * 1  2/83 (2.41%)  5/84 (5.95%)  0/83 (0.00%)  1/84 (1.19%)  0/80 (0.00%)  0/84 (0.00%) 
Diarrhoea infectious * 1  2/83 (2.41%)  4/84 (4.76%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Oral candidiasis * 1  2/83 (2.41%)  2/84 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Pharyngitis * 1  1/83 (1.20%)  3/84 (3.57%)  0/83 (0.00%)  0/84 (0.00%)  1/80 (1.25%)  0/84 (0.00%) 
Roseola * 1  3/83 (3.61%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  1/80 (1.25%)  0/84 (0.00%) 
Urinary tract infection * 1  1/83 (1.20%)  2/84 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  1/84 (1.19%) 
Acute tonsillitis * 1  1/83 (1.20%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  2/80 (2.50%)  0/84 (0.00%) 
Nasopharyngitis * 1  0/83 (0.00%)  2/84 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/80 (1.25%)  0/84 (0.00%) 
Otitis media acute * 1  0/83 (0.00%)  2/84 (2.38%)  0/83 (0.00%)  0/84 (0.00%)  1/80 (1.25%)  2/84 (2.38%) 
Abscess limb * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Bacteriuria * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Bronchopneumonia * 1  1/83 (1.20%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Cellulitis * 1  0/83 (0.00%)  1/84 (1.19%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Croup infectious * 1  1/83 (1.20%)  0/84 (0.00%)  0/83 (0.00%)  0/84 (0.00%)  0/80 (0.00%)  0/84 (0.00%) 
Exanthema subitum * 1