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Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)

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: NCT00312858
Recruitment Status : Completed
First Posted : April 11, 2006
Results First Posted : August 3, 2009
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Hepatitis A Virus
Interventions Biological: Comparator: VAQTA™ (Hepatitis A vaccine)
Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Enrollment 653
Recruitment Details

39 clinical sites in the United States

Date first participant visit: 14-Apr-2006

Date last participant visit: 25-Mar-2008

Pre-assignment Details  
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit. VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Period Title: Overall Study
Started 330 323
Visit 1 330 323
Visit 2 305 294
Visit 3 273 261
Visit 4 262 240
Completed 262 230
Not Completed 68 93
Reason Not Completed
Adverse Event             0             1
Lost to Follow-up             25             42
Protocol Violation             3             8
Withdraw by Participant             20             20
Participant Moved             11             10
Other             9             12
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™ Total
Hide Arm/Group Description VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit. VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit. Total of all reporting groups
Overall Number of Baseline Participants 330 323 653
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 330 participants 323 participants 653 participants
12.4  (0.80) 12.5  (0.89) 12.4  (0.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 330 participants 323 participants 653 participants
Female
156
  47.3%
166
  51.4%
322
  49.3%
Male
174
  52.7%
157
  48.6%
331
  50.7%
1.Primary Outcome
Title Antibody Response to Hepatitis A - Participants With a Serological Response
Hide Description Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Time Frame 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 182 159
Measure Type: Number
Unit of Measure: Participants
182 158
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Comparison of the difference (percentage points) in estimated response rates of Arm 1 – Arm 2.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference of seroresponse rates excluding a decrease of 10 percentage points or more (lower bound >-10.0).
Statistical Test of Hypothesis P-Value <0.001
Comments Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided α=0.025 level.
Method Miettinen and Nurminen
Comments For testing the non-inferiority of 2 proportions. Stratified by investigator.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.7
Confidence Interval 95%
-1.4 to 3.8
Estimation Comments Difference in estimated response rates of Arm 1 – Arm 2.
2.Primary Outcome
Title Antibody Response to Varicella - Participants With a Serological Response
Hide Description Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Time Frame 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 225 232
Measure Type: Number
Unit of Measure: Participants
Number of participants ≥1.25 gpELISA units/mL 222 231
Number of participants ≥5 gpELISA units/mL 210 228
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Comparison of the difference (percentage points) in estimated response rates of Arm 1 – Arm 2 for participants with initial serostatus <1.25 gpELISA units/mL
Type of Statistical Test Non-Inferiority or Equivalence
Comments Similarity (non-inferiority) based on lower bound of the 2-sided 95% CI on the risk difference seroresponse rates excluding a decrease of 10 percentage points or more (lower bound >-10.0).
Statistical Test of Hypothesis P-Value 0.013
Comments Similarity (non-inferiority) indicated that the risk difference was statistically significantly greater than the pre-specified clinically relevant difference of -10 percentage points at the 1-sided multiplicity-adjusted α=0.025 level.
Method Miettinen and Nurminen
Comments For testing the non-inferiority of 2 proportions. Stratified by investigator.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -5.1
Confidence Interval 95%
-9.3 to -1.4
Estimation Comments Difference in estimated response rates of Arm 1 – Arm 2.
3.Primary Outcome
Title Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Hide Description Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Time Frame 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 330 323
Geometric Mean (95% Confidence Interval)
Unit of Measure: mcg/mL
Serotype 4 (n=246, 247)
1.8
(1.6 to 2.1)
1.6
(1.4 to 1.8)
Serotype 6B (n=246, 246)
9.5
(8.3 to 11.0)
9.6
(8.5 to 10.8)
Serotype 9V (n=247, 247)
3.7
(3.2 to 4.2)
4.1
(3.7 to 4.7)
Serotype 14 (n=248, 247)
7.7
(6.8 to 8.8)
7.4
(6.5 to 8.4)
Serotype 18C (n=247, 247)
2.9
(2.6 to 3.3)
2.6
(2.3 to 3.0)
Serotype 19F (n=248, 248)
4.0
(3.5 to 4.5)
3.8
(3.3 to 4.3)
Serotype 23F (n=247, 247)
4.9
(4.3 to 5.6)
4.5
(3.9 to 5.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Serotype 4
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Response ratio (Arm 1 / Arm 2)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.9 to 1.3
Estimation Comments Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Serotype 6B
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Response ratio (Arm 1 / Arm 2)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.8 to 1.2
Estimation Comments Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Serotype 9V
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Response ratio (Arm 1 / Arm 2)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.8 to 1.0
Estimation Comments Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Serotype 14
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Response ratio (Arm 1 / Arm 2)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.9 to 1.2
Estimation Comments Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Serotype 18C
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Response ratio (Arm 1 / Arm 2)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.9 to 1.3
Estimation Comments Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Serotype 19F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Response ratio (Arm 1 / Arm 2)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.9 to 1.2
Estimation Comments Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Arm 1: VAQTA™ + ProQuad™ + Prevnar™, Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Comments Serotype 23F
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority criterion is met if the lower bound of the 95% confidence interval of the response ratio is >0.5, excluding a decrease of 2-fold or more
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Response ratio (Arm 1 / Arm 2)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
1.0 to 1.3
Estimation Comments Response ratio is based on statistical models adjusting the GMT for combined study center and prevaccination titer
4.Primary Outcome
Title Participants With 1 or More Systemic Adverse Experience
Hide Description Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Time Frame 6 weeks post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 311 274
Measure Type: Number
Unit of Measure: Participants
178 80
5.Primary Outcome
Title Participants With 1 or More Systemic Adverse Experience
Hide Description Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Time Frame 4 weeks post dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 263 251
Measure Type: Number
Unit of Measure: Participants
88 77
6.Primary Outcome
Title Participants With 1 or More Systemic Adverse Experience.
Hide Description Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 330 286
Measure Type: Number
Unit of Measure: Participants
204 133
7.Primary Outcome
Title Participants With 1 or More Injection-site Adverse Experience
Hide Description Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Time Frame 6 weeks post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 311 274
Measure Type: Number
Unit of Measure: Participants
83 61
8.Primary Outcome
Title Participants With 1 or More Injection-site Adverse Experience
Hide Description Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Time Frame 4 weeks post dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 263 251
Measure Type: Number
Unit of Measure: Participants
54 66
9.Primary Outcome
Title Participants With 1 or More Injection-site Adverse Experience
Hide Description Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 330 286
Measure Type: Number
Unit of Measure: Participants
105 95
10.Primary Outcome
Title Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Hide Description Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Time Frame 6 weeks post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 285 243
Measure Type: Number
Unit of Measure: Participants
10 5
11.Primary Outcome
Title Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Hide Description Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Time Frame 4 weeks post dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 237 221
Measure Type: Number
Unit of Measure: Participants
6 5
12.Primary Outcome
Title Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Hide Description Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 293 257
Measure Type: Number
Unit of Measure: Participants
16 10
13.Primary Outcome
Title Participants With 1 or More Serious Vaccine-related Adverse Experience
Hide Description Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame 6 weeks post dose 1
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 311 274
Measure Type: Number
Unit of Measure: Participants
0 1
14.Primary Outcome
Title Participants With 1 or More Serious Vaccine-related Adverse Experience
Hide Description Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame 4 weeks post dose 2
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 263 251
Measure Type: Number
Unit of Measure: Participants
0 0
15.Primary Outcome
Title Participants With 1 or More Serious Vaccine-related Adverse Experience
Hide Description Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 330 286
Measure Type: Number
Unit of Measure: Participants
0 1
16.Other Pre-specified Outcome
Title Antibody Response to Hepatitis A – Geometric Mean Titer
Hide Description Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus
Time Frame 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 182 159
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
4976.6
(4067.6 to 6088.6)
6123.2
(4825.6 to 7769.7)
17.Other Pre-specified Outcome
Title Antibody Response to Varicella - Geometric Mean Titer
Hide Description Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL
Time Frame 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 225 232
Geometric Mean (95% Confidence Interval)
Unit of Measure: gpELISA units/mL
14.6
(13.3 to 16.1)
16.4
(15.1 to 17.7)
18.Other Pre-specified Outcome
Title Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response
Hide Description Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4
Time Frame 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes contained in Prevnar™.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 246 247
Measure Type: Number
Unit of Measure: Participants
241 237
19.Other Pre-specified Outcome
Title Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response
Hide Description Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B
Time Frame 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes contained in Prevnar™.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 246 246
Measure Type: Number
Unit of Measure: Participants
242 245
20.Other Pre-specified Outcome
Title Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response
Hide Description Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V
Time Frame 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes contained in Prevnar™.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 247 247
Measure Type: Number
Unit of Measure: Participants
243 245
21.Other Pre-specified Outcome
Title Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response
Hide Description Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14
Time Frame 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes contained in Prevnar™.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 248 247
Measure Type: Number
Unit of Measure: Participants
245 244
22.Other Pre-specified Outcome
Title Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response
Hide Description Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C
Time Frame 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes contained in Prevnar™.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 247 247
Measure Type: Number
Unit of Measure: Participants
245 243
23.Other Pre-specified Outcome
Title Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response
Hide Description Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F
Time Frame 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes contained in Prevnar™.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 248 248
Measure Type: Number
Unit of Measure: Participants
245 244
24.Other Pre-specified Outcome
Title Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response
Hide Description Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F
Time Frame 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes contained in Prevnar™.
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description:
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
Overall Number of Participants Analyzed 247 247
Measure Type: Number
Unit of Measure: Participants
245 246
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Hide Arm/Group Description VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit. VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
All-Cause Mortality
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2      6    
Gastrointestinal disorders     
Gastrointestinal Haemorrhage * 1  0/330 (0.00%)  0 1/323 (0.31%)  1
Infections and infestations     
Pneumonia * 1  1/330 (0.30%)  1 0/323 (0.00%)  0
Cellulitis * 1  1/330 (0.30%)  1 0/323 (0.00%)  0
Perineal Abscess * 1  1/330 (0.30%)  1 0/323 (0.00%)  0
Genital Abscess * 1  0/330 (0.00%)  0 1/323 (0.31%)  1
Bronchopneumonia * 1  0/330 (0.00%)  0 1/323 (0.31%)  1
Gastroenteritis * 1  0/330 (0.00%)  0 2/323 (0.62%)  2
Metabolism and nutrition disorders     
Dehydration * 1  0/330 (0.00%)  0 2/323 (0.62%)  2
Nervous system disorders     
Febrile Convulsion * 1  0/330 (0.00%)  0 1/323 (0.31%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: VAQTA™ + ProQuad™ + Prevnar™ Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   231      172    
Blood and lymphatic system disorders     
Lymphadenopathy * 1  1/330 (0.30%)  0/286 (0.00%) 
Ear and labyrinth disorders     
Ear Pain * 1  2/330 (0.61%)  2/286 (0.70%) 
Otorrhea * 1  0/330 (0.00%)  1/286 (0.35%) 
Eye disorders     
Conjunctivitis * 1  3/330 (0.91%)  4/286 (1.40%) 
Eye Discharge * 1  2/330 (0.61%)  0/286 (0.00%) 
Eye Swelling * 1  0/330 (0.00%)  1/286 (0.35%) 
Gastrointestinal disorders     
Abdominal Pain Upper * 1  1/330 (0.30%)  0/286 (0.00%) 
Constipation * 1  2/330 (0.61%)  1/286 (0.35%) 
Diarrhea * 1  16/330 (4.85%)  8/286 (2.80%) 
Flatulence * 1  0/330 (0.00%)  1/286 (0.35%) 
Gastroesophageal Reflux Disease * 1  1/330 (0.30%)  0/286 (0.00%) 
Nausea * 1  0/330 (0.00%)  1/286 (0.35%) 
Oral Pain * 1  0/330 (0.00%)  1/286 (0.35%) 
Teething * 1  0/330 (0.00%)  1/286 (0.35%) 
Vomiting * 1  10/330 (3.03%)  6/286 (2.10%) 
General disorders     
Body Temperature * 1  1/330 (0.30%)  0/286 (0.00%) 
Fatigue * 1  1/330 (0.30%)  1/286 (0.35%) 
Irritability * 1  24/330 (7.27%)  17/286 (5.94%) 
Pain * 1  0/330 (0.00%)  1/286 (0.35%) 
Pyrexia * 1  126/330 (38.18%)  53/286 (18.53%) 
Bruising, Injection site for VAQTA™ * 1  6/330 (1.82%)  7/286 (2.45%) 
Erythema, Injection site for VAQTA™  1  45/330 (13.64%)  51/286 (17.83%) 
Haemorrhage, Injection site for VAQTA™ * 1  1/330 (0.30%)  0/286 (0.00%) 
Nodule, Injection site for VAQTA™ * 1  1/330 (0.30%)  0/286 (0.00%) 
Pain, Injection site for VAQTA™  1  86/330 (26.06%)  73/286 (25.52%) 
Rash, Injection site for VAQTA™ * 1  5/330 (1.52%)  1/286 (0.35%) 
Reaction, Injection site for VAQTA™ * 1  1/330 (0.30%)  0/286 (0.00%) 
Swelling, Injection site for VAQTA™  1  32/330 (9.70%)  38/286 (13.29%) 
Warmth, Injection site for VAQTA™ * 1  2/330 (0.61%)  0/286 (0.00%) 
Immune system disorders     
Drug Hypersensitivity * 1  1/330 (0.30%)  0/286 (0.00%) 
Multiple Allergies * 1  3/330 (0.91%)  0/286 (0.00%) 
Seasonal Allergy * 1  0/330 (0.00%)  1/286 (0.35%) 
Infections and infestations     
Acute Sinusitis * 1  1/330 (0.30%)  0/286 (0.00%) 
Adenovirus Infection * 1  0/330 (0.00%)  1/286 (0.35%) 
Body Tinea * 1  1/330 (0.30%)  0/286 (0.00%) 
Bronchitis * 1  1/330 (0.30%)  1/286 (0.35%) 
Candida Nappy Rash * 1  2/330 (0.61%)  1/286 (0.35%) 
Candidiasis * 1  0/330 (0.00%)  1/286 (0.35%) 
Conjunctivitis Bacterial * 1  0/330 (0.00%)  1/286 (0.35%) 
Conjunctivitis Infective * 1  3/330 (0.91%)  1/286 (0.35%) 
Conjunctivitis Viral * 1  1/330 (0.30%)  0/286 (0.00%) 
Croup Infectious * 1  3/330 (0.91%)  4/286 (1.40%) 
Ear Infection * 1  6/330 (1.82%)  1/286 (0.35%) 
Enterobiasis * 1  0/330 (0.00%)  1/286 (0.35%) 
Eye Infection * 1  2/330 (0.61%)  0/286 (0.00%) 
Gastroenteritis * 1  3/330 (0.91%)  2/286 (0.70%) 
Gastroenteritis Viral * 1  2/330 (0.61%)  3/286 (1.05%) 
Impetigo * 1  1/330 (0.30%)  0/286 (0.00%) 
Influenza * 1  1/330 (0.30%)  2/286 (0.70%) 
Mycoplasma Infection * 1  0/330 (0.00%)  1/286 (0.35%) 
Nasopharyngitis * 1  12/330 (3.64%)  7/286 (2.45%) 
Otitis Media * 1  25/330 (7.58%)  17/286 (5.94%) 
Otitis Media Acute * 1  2/330 (0.61%)  3/286 (1.05%) 
Pharyngitis * 1  3/330 (0.91%)  3/286 (1.05%) 
Pharyngitis Streptococcal * 1  2/330 (0.61%)  3/286 (1.05%) 
Pharyngotonsillitis * 1  1/330 (0.30%)  0/286 (0.00%) 
Pneumonia * 1  0/330 (0.00%)  1/286 (0.35%) 
Respiratory Syncytial Virus Infection * 1  0/330 (0.00%)  1/286 (0.35%) 
Rhinitis * 1  7/330 (2.12%)  7/286 (2.45%) 
Roseola * 1  5/330 (1.52%)  1/286 (0.35%) 
Sinusitis * 1  3/330 (0.91%)  0/286 (0.00%) 
Skin Infection * 1  1/330 (0.30%)  0/286 (0.00%) 
Tinea Pedis * 1  0/330 (0.00%)  1/286 (0.35%) 
Upper Respiratory Tract Infection * 1  34/330 (10.30%)  19/286 (6.64%) 
Viraemia * 1  1/330 (0.30%)  0/286 (0.00%) 
Viral Infection * 1  9/330 (2.73%)  1/286 (0.35%) 
Viral Pharyngitis * 1  1/330 (0.30%)  0/286 (0.00%) 
Viral Skin Infection * 1  2/330 (0.61%)  2/286 (0.70%) 
Viral upper respiratory tract Infection * 1  0/330 (0.00%)  2/286 (0.70%) 
Injury, poisoning and procedural complications     
Arthropod Bite * 1  2/330 (0.61%)  2/286 (0.70%) 
Arthropod Sting * 1  1/330 (0.30%)  0/286 (0.00%) 
Contusion * 1  1/330 (0.30%)  0/286 (0.00%) 
Head Injury * 1  1/330 (0.30%)  0/286 (0.00%) 
Lower Limb Fracture * 1  1/330 (0.30%)  0/286 (0.00%) 
Sunburn * 1  1/330 (0.30%)  0/286 (0.00%) 
Thermal Burn * 1  0/330 (0.00%)  1/286 (0.35%) 
Metabolism and nutrition disorders     
Anorexia * 1  2/330 (0.61%)  1/286 (0.35%) 
Decreased Appetite * 1  1/330 (0.30%)  0/286 (0.00%) 
Hypervitaminosis A * 1  1/330 (0.30%)  0/286 (0.00%) 
Iron Deficiency * 1  0/330 (0.00%)  1/286 (0.35%) 
Musculoskeletal and connective tissue disorders     
Muscular Weakness * 1  1/330 (0.30%)  0/286 (0.00%) 
Pain In Extremity * 1  1/330 (0.30%)  0/286 (0.00%) 
Nervous system disorders     
Febrile Convulsion * 1  1/330 (0.30%)  0/286 (0.00%) 
Headache * 1  1/330 (0.30%)  1/286 (0.35%) 
Lethargy * 1  1/330 (0.30%)  1/286 (0.35%) 
Tremor * 1  1/330 (0.30%)  0/286 (0.00%) 
Psychiatric disorders     
Crying * 1  1/330 (0.30%)  0/286 (0.00%) 
Insomnia * 1  1/330 (0.30%)  1/286 (0.35%) 
Restlessness * 1  0/330 (0.00%)  2/286 (0.70%) 
Sleep Disorder * 1  0/330 (0.00%)  1/286 (0.35%) 
Reproductive system and breast disorders     
Penile Discharge * 1  0/330 (0.00%)  1/286 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/330 (0.30%)  1/286 (0.35%) 
Bronchial Hyperreactivity * 1  1/330 (0.30%)  2/286 (0.70%) 
Cough * 1  15/330 (4.55%)  9/286 (3.15%) 
Nasal Congestion * 1  7/330 (2.12%)  3/286 (1.05%) 
Paranasal Sinus Hypersecretion * 1  1/330 (0.30%)  1/286 (0.35%) 
Pharyngolaryngeal Pain * 1  1/330 (0.30%)  0/286 (0.00%) 
Respiratory Tract Congestion * 1  3/330 (0.91%)  2/286 (0.70%) 
Rhinalgia * 1  0/330 (0.00%)  1/286 (0.35%) 
Rhinitis Allergic * 1  2/330 (0.61%)  1/286 (0.35%) 
Rhinorrhea * 1  16/330 (4.85%)  9/286 (3.15%) 
Sinus Congestion * 1  2/330 (0.61%)  1/286 (0.35%) 
Sneezing * 1  2/330 (0.61%)  1/286 (0.35%) 
Wheezing * 1  0/330 (0.00%)  1/286 (0.35%) 
Skin and subcutaneous tissue disorders     
Dermatitis * 1  1/330 (0.30%)  0/286 (0.00%) 
Dermatitis Allergic * 1  1/330 (0.30%)  2/286 (0.70%) 
Dermatitis Atopic * 1  1/330 (0.30%)  1/286 (0.35%) 
Dermatitis Contact * 1  1/330 (0.30%)  0/286 (0.00%) 
Dermatitis Diaper * 1  26/330 (7.88%)  9/286 (3.15%) 
Eczema * 1  3/330 (0.91%)  3/286 (1.05%) 
Erythema * 1  2/330 (0.61%)  0/286 (0.00%) 
Erythema Multiforme * 1  1/330 (0.30%)  0/286 (0.00%) 
Rash * 1  10/330 (3.03%)  4/286 (1.40%) 
Rash Macular * 1  1/330 (0.30%)  0/286 (0.00%) 
Rash Maculo-papular * 1  1/330 (0.30%)  0/286 (0.00%) 
Rash Morbilliform * 1  8/330 (2.42%)  1/286 (0.35%) 
Rash Rubelliform * 1  1/330 (0.30%)  0/286 (0.00%) 
Rash Vesicular * 1  4/330 (1.21%)  2/286 (0.70%) 
Urticaria * 1  0/330 (0.00%)  1/286 (0.35%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00312858     History of Changes
Other Study ID Numbers: V251-067
2005_075
First Submitted: April 7, 2006
First Posted: April 11, 2006
Results First Submitted: March 24, 2009
Results First Posted: August 3, 2009
Last Update Posted: April 13, 2017