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A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to MCV4, Tdap and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 10 Through 12 Years of Age

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ClinicalTrials.gov Identifier: NCT01461980
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : May 25, 2015
Last Update Posted : December 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Vaccines
Meningococcal Vaccines
Interventions Biological: rLP2086 + MCV4 + Tdap
Biological: MCV4 + Tdap + saline
Biological: rLP2086 + saline
Enrollment 2648
Recruitment Details  
Pre-assignment Details A total of 2648 participants were enrolled in this study. Of these, 19 participants were randomized but did not receive study vaccination.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline Saline+Saline+rLP2086
Hide Arm/Group Description Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Period Title: Overall Study
Started 888 878 882
Vaccination 1 884 870 875
Vaccination 2 802 819 799
Vaccination 3 757 777 748
Completed 722 733 717
Not Completed 166 145 165
Reason Not Completed
Other             9             8             6
Medication error             7             5             6
Adverse Event             12             5             6
Protocol Violation             12             19             16
No longer meets eligibility criteria             18             9             19
Lost to Follow-up             52             53             51
No longer willing to participate             52             38             54
Randomized but not vaccinated             4             8             7
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline Saline+Saline+rLP2086 Total
Hide Arm/Group Description Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month. Total of all reporting groups
Overall Number of Baseline Participants 888 878 882 2648
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 888 participants 878 participants 882 participants 2648 participants
10.6  (0.70) 10.6  (0.69) 10.6  (0.67) 10.6  (0.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 888 participants 878 participants 882 participants 2648 participants
Female
454
  51.1%
427
  48.6%
417
  47.3%
1298
  49.0%
Male
434
  48.9%
451
  51.4%
465
  52.7%
1350
  51.0%
1.Primary Outcome
Title Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens
Hide Description Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
Time Frame 1 Month after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Overall Number of Participants Analyzed 778 780
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Diphtheria
9.3
(8.67 to 9.92)
9.8
(9.23 to 10.51)
Tetanus
9.4
(8.95 to 9.98)
10.3
(9.75 to 10.85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Diphtheria: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Diphtheria antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.86 to 1.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Tetanus: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Tetanus antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.85 to 0.99
Estimation Comments [Not Specified]
2.Primary Outcome
Title Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens
Hide Description Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.
Time Frame 1 Month after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Overall Number of Participants Analyzed 778 780
Geometric Mean (95% Confidence Interval)
Unit of Measure: EU/mL
Pertussis toxoid
13.2
(12.35 to 14.14)
14.2
(13.28 to 15.20)
Pertussis filamentous hemagglutinin
112.0
(106.15 to 118.14)
122.9
(116.42 to 129.84)
Pertussis pertactin
202.0
(187.77 to 217.25)
228.9
(212.72 to 246.35)
Pertussis fimbrial agglutinogens types 2+3
138.1
(121.20 to 157.33)
154.2
(135.30 to 175.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Pertussis toxoid: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Pertussis toxoid).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.85 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Pertussis filamentous hemagglutinin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis filamentous hemagglutinin antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.84 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Pertussis pertactin: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis pertactin antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.80 to 0.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Pertussis fimbriae agglutinogens types 2 + 3: CIs for GMC ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for pertussis fimbriae agglutinogens types 2 + 3 antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMC ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMC ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMC Ratio
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.74 to 1.08
Estimation Comments [Not Specified]
3.Primary Outcome
Title Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens
Hide Description Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.
Time Frame 1 Month after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Post vaccination 1 evaluable immunogenicity population. Here, 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Overall Number of Participants Analyzed 779 781
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Serogroup A (N=763, 772)
4647.3
(4317.66 to 5002.09)
5113.0
(4748.73 to 5505.17)
Serogroup C (N=768, 767)
1679.2
(1539.63 to 1831.38)
1650.2
(1519.01 to 1792.65)
Serogroup Y (N=771, 770)
2212.6
(2056.08 to 2381.08)
2244.9
(2088.70 to 2412.89)
Serogroup W-135 (N=751, 765)
5925.1
(5469.77 to 6418.33)
6367.9
(5872.68 to 6904.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Serogroup A: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup A antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.82 to 1.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Serogroup C: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup C antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.90 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Serogroup Y: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup Y antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.89 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, MCV4+Tdap+Saline
Comments Serogroup W-135: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for Serogroup W-135 antigens).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.83 to 1.04
Estimation Comments [Not Specified]
4.Primary Outcome
Title Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3
Hide Description Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Time Frame 1 Month after Vaccination 3
Hide Outcome Measure Data
Hide Analysis Population Description
Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.
Arm/Group Title MCV4+Tdap+rLP2086 Saline+Saline+rLP2086
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Number of Participants Analyzed 683 679
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
PMB80 [A22] (N=679, 674)
45.9
(42.74 to 49.35)
49.7
(46.43 to 53.30)
PMB2948 [B24] (N=670, 656)
24.8
(23.11 to 26.58)
27.4
(25.58 to 29.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, Saline+Saline+rLP2086
Comments PMB80 [A22]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.84 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MCV4+Tdap+rLP2086, Saline+Saline+rLP2086
Comments PMB2948 [B24]: CIs for GMT ratio were back transformations of a confidence interval based on the Student t distribution for the mean difference of the logarithms of the measures (Group 1 - Group 2 for hSBA strain titers).
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority criteria margin was 1.5-fold and statistical inference was based on the CIs of the GMT ratios. Non-inferiority was achieved when the lower limit of the 2-sided 95% CI for the GMT ratios after vaccination 1 was greater than 0.67.
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.82 to 1.00
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens
Hide Description Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.
Time Frame 1 Month after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Overall Number of Participants Analyzed 779 781
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Diphtheria (N=774, 780)
98.6
(97.5 to 99.3)
98.3
(97.2 to 99.1)
Tetanus (N=774, 780)
97.7
(96.3 to 98.6)
97.4
(96.1 to 98.4)
Pertussis toxoid (N=774, 780)
68.1
(64.7 to 71.4)
72.7
(69.4 to 75.8)
Pertussis filamentous hemagglutinin (N=774, 780)
85.3
(82.6 to 87.7)
89.2
(86.8 to 91.3)
Pertussis pertactin (N=774, 780)
96.0
(94.4 to 97.3)
96.2
(94.6 to 97.4)
Pertussis fimbriae AG types 2+3 (N=774, 780)
79.5
(76.4 to 82.3)
81.9
(79.0 to 84.6)
Serogroup A (N=712, 736)
85.4
(82.6 to 87.9)
88.6
(86.1 to 90.8)
Serogroup C (N=738, 742)
89.3
(86.8 to 91.4)
88.9
(86.5 to 91.1)
Serogroup Y (N=754, 753)
90.5
(88.1 to 92.5)
93.6
(91.6 to 95.3)
Serogroup W-135 (N=729, 752)
97.1
(95.6 to 98.2)
97.2
(95.8 to 98.3)
6.Secondary Outcome
Title Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens
Hide Description Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.
Time Frame 1 Month after Vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Post vaccination 1 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies participants with valid, determinate assay results for given antigen.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Overall Number of Participants Analyzed 778 780
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Tetanus
99.1
(98.2 to 99.6)
99.0
(98.0 to 99.6)
Diphtheria
98.1
(96.8 to 98.9)
99.0
(98.0 to 99.6)
7.Secondary Outcome
Title Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2
Hide Description Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.
Time Frame Before Vaccination 1, 1 Month after Vaccination (Vac) 2
Hide Outcome Measure Data
Hide Analysis Population Description
Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Arm/Group Title MCV4+Tdap+rLP2086 Saline+Saline+rLP2086
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Number of Participants Analyzed 683 679
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Before Vaccination 1: PMB80 [A22] (N=677, 677)
8.5
(8.28 to 8.64)
8.6
(8.39 to 8.84)
Before Vaccination 1: PMB2948 [B24] (N=677, 676)
4.1
(4.04 to 4.19)
4.2
(4.10 to 4.27)
1 Month after Vac 2: PMB80 [A22] (N=669, 665)
23.7
(22.10 to 25.40)
23.8
(22.14 to 25.54)
1 Month after Vac 2: PMB2948 [B24] (N=656, 650)
12.0
(11.12 to 12.99)
13.0
(12.03 to 14.13)
8.Secondary Outcome
Title Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)
Hide Description Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].
Time Frame Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3
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Hide Analysis Population Description
Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Arm/Group Title MCV4+Tdap+rLP2086 Saline+Saline+rLP2086
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Number of Participants Analyzed 683 679
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Before Vaccination 1: PMB80[A22] 1:16 (N=677, 677)
4.4
(3.0 to 6.3)
5.6
(4.0 to 7.6)
1 month after Vac 2: PMB80[A22] 1:16 (N= 669, 665)
68.0
(64.3 to 71.5)
68.0
(64.3 to 71.5)
1 month after Vac 3: PMB80 [A22] 1:16 (N=679, 674)
87.5
(84.8 to 89.9)
91.4
(89.0 to 93.4)
Before Vaccination 1: PMB2948[B24] 1:8 (N=677,676)
1.6
(0.8 to 2.9)
3.4
(2.2 to 5.1)
1 month after Vac 2: PMB2948[B24] 1:8 (N=656, 650)
62.3
(58.5 to 66.1)
66.0
(62.2 to 69.6)
1 month after Vac 3: PMB2948[B24] 1:8 (N=670, 656)
90.0
(87.5 to 92.2)
92.7
(90.4 to 94.6)
9.Secondary Outcome
Title Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level
Hide Description Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.
Time Frame Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3
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Hide Analysis Population Description
Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.
Arm/Group Title MCV4+Tdap+rLP2086 Saline+Saline+rLP2086
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Number of Participants Analyzed 683 679
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Before Vaccination 1: PMB80[A22] 1:4 (N=677,677)
6.9
(5.1 to 9.1)
7.5
(5.7 to 9.8)
1 month after Vac 2: PMB80[A22] 1:4 (N=669, 665)
68.2
(64.5 to 71.7)
68.6
(64.9 to 72.1)
1 month after Vac 3: PMB80[A22] 1:4 (N=679, 674)
87.8
(85.1 to 90.1)
91.7
(89.3 to 93.7)
Before Vaccination 1: PMB80[A22] 1:8 (N=677, 677)
5.0
(3.5 to 6.9)
6.4
(4.6 to 8.5)
1 month after Vac 2: PMB80[A22] 1:8 (N=669, 665)
68.2
(64.5 to 71.7)
68.1
(64.4 to 71.7)
1 month after Vac 3: PMB80[A22] 1:8 (N=679, 674)
87.6
(84.9 to 90.0)
91.5
(89.2 to 93.5)
Before Vaccination 1: PMB80[A22] 1:32 (N=677, 677)
2.7
(1.6 to 4.2)
3.2
(2.0 to 4.9)
1 month after Vac 2: PMB80[A22] 1:32 (N=669, 665)
55.0
(51.1 to 58.8)
54.4
(50.6 to 58.3)
1 month after Vac 3: PMB80[A22] 1:32 (N=679, 674)
81.3
(78.2 to 84.2)
84.7
(81.8 to 87.4)
Before Vaccination 1: PMB80[A22] 1:64 (N=677,677)
0.7
(0.2 to 1.7)
1.0
(0.4 to 2.1)
1 month after Vac 2: PMB80[A22] 1:64 (N= 669, 665)
25.6
(22.3 to 29.0)
25.0
(21.7 to 28.4)
1 month after Vac 3: PMB80[A22] 1:64 (N=679, 674)
52.7
(48.9 to 56.5)
55.6
(51.8 to 59.4)
Before Vaccination 1: PMB80[A22] 1:128 (N=677,677)
0.1
(0.0 to 0.8)
0.4
(0.1 to 1.3)
1 month after Vac 2: PMB80[A22] 1:128 (N=669, 665)
6.9
(5.1 to 9.1)
7.5
(5.6 to 9.8)
1 month after Vac 3: PMB80[A22] 1:128 (N=679, 674)
23.6
(20.4 to 26.9)
23.3
(20.2 to 26.7)
Before Vaccination 1: PMB2948[B24] 1:4 (N=677,676)
2.1
(1.1 to 3.4)
3.7
(2.4 to 5.4)
1 month after Vac 2: PMB2948[B24] 1:4 (N=656, 650)
64.8
(61.0 to 68.4)
68.2
(64.4 to 71.7)
1 month after Vac 3: PMB2948[B24] 1:4 (N=670, 656)
90.7
(88.3 to 92.8)
93.1
(90.9 to 95.0)
Before Vaccination 1: PMB2948[B24] 1:16(N=677,676)
1.5
(0.7 to 2.7)
2.1
(1.1 to 3.5)
1 month after Vac 2: PMB2948[B24] 1:16(N=656,650)
57.6
(53.7 to 61.4)
60.3
(56.4 to 64.1)
1 month after Vac 3: PMB2948[B24] 1:16(N=670,656)
86.7
(83.9 to 89.2)
88.9
(86.2 to 91.2)
Before Vaccination 1: PMB2948[B24] 1:32(N=677,676)
0.4
(0.1 to 1.3)
0.6
(0.2 to 1.5)
1 month after Vac 2: PMB2948[B24] 1:32(N=656,650)
26.2
(22.9 to 29.8)
28.2
(24.7 to 31.8)
1 month after Vac 3: PMB2948[B24] 1:32(N=670, 656)
55.1
(51.2 to 58.9)
60.7
(56.8 to 64.4)
Before Vaccination 1:PMB2948[B24] 1:64(N= 677,676)
0.4
(0.1 to 1.3)
0.3
(0.0 to 1.1)
1 month after Vac 2: PMB2948[B24] 1:64 (N=656,650)
8.7
(6.6 to 11.1)
10.3
(8.1 to 12.9)
1 month after Vac 3: PMB2948[B24] 1:64 (N=670,656)
22.5
(19.4 to 25.9)
24.1
(20.9 to 27.5)
Before Vaccination 1:PMB2948[B24] 1:128(N=677,676)
0.1
(0.0 to 0.8)
0.1
(0.0 to 0.8)
1 month after Vac 2: PMB2948[B24] 1:128(N=656,650)
2.4
(1.4 to 3.9)
3.4
(2.1 to 5.1)
1 month after Vac 3: PMB2948[B24] 1:128(N=670,656)
6.6
(4.8 to 8.7)
7.8
(5.8 to 10.1)
10.Other Pre-specified Outcome
Title Immunogloblulin G (IgG) Measured by GMC
Hide Description IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.
Time Frame Before Vaccination 1, 1 Month after Vaccination 1
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Post vaccination 1 evaluable immunogenicity population.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline
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Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Overall Number of Participants Analyzed 779 781
Geometric Mean (95% Confidence Interval)
Unit of Measure: microgram per milliliter (mcg/mL)
Before Vaccination 1: Serogroup A
0.17
(0.16 to 0.19)
0.15
(0.14 to 0.17)
1 Month after Vaccination 1: Serogroup A
11.42
(10.30 to 12.65)
11.38
(10.21 to 12.67)
Before Vaccination 1: Serogroup C
0.11
(0.10 to 0.12)
0.11
(0.10 to 0.12)
1 Month after Vaccination 1: Serogroup C
5.59
(4.90 to 6.39)
5.47
(4.79 to 6.23)
Before Vaccination 1: Serogroup Y
0.14
(0.13 to 0.14)
0.13
(0.13 to 0.14)
1 Month after Vaccination 1: Serogroup Y
2.49
(2.22 to 2.79)
2.14
(1.92 to 2.39)
Before Vaccination 1: Serogroup W-135
0.13
(0.13 to 0.14)
0.13
(0.13 to 0.14)
1 Month after Vaccination 1: Serogroup W-135
1.79
(1.59 to 2.01)
1.84
(1.62 to 2.09)
11.Other Pre-specified Outcome
Title Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level
Hide Description [Not Specified]
Time Frame 1 Month after Vaccination (Vac) 2, 3
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Hide Analysis Population Description
Post vaccination 3 evaluable immunogenicity population. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.
Arm/Group Title MCV4+Tdap+rLP2086 Saline+Saline+rLP2086
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Number of Participants Analyzed 683 679
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1 month after Vac 2 : PMB80 [A22] (N=663, 663)
64.3
(60.5 to 67.9)
63.7
(59.9 to 67.3)
1 month after Vac 3 : PMB80 [A22] (N=673, 672)
84.0
(81.0 to 86.6)
88.7
(86.0 to 91.0)
1 month after Vac 2 : PMB2948 [B24] (N=650, 647)
56.3
(52.4 to 60.2)
58.4
(54.5 to 62.3)
1 month after Vac 3 : PMB2948 [B24] (N=664, 653)
85.7
(82.8 to 88.3)
87.7
(85.0 to 90.2)
12.Other Pre-specified Outcome
Title Percentage of Participants With at Least One Adverse Event (AE)
Hide Description An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.
Time Frame Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)
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Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline Saline+Saline+rLP2086
Hide Arm/Group Description:
Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
Overall Number of Participants Analyzed 883 870 875
Measure Type: Number
Unit of Measure: percentage of participants
Vaccination phase: Adverse Events (N=883,870,875) 42.9 42.6 46.2
Follow-up phase: Adverse Events (N=777,776,771) 1.0 0.5 1.3
Time Frame AEs: recorded from signing of informed consent form (ICF) to completion of study. SAEs: recorded from signing of ICF to 196 days of follow up period. Participant recorded pre--specified AEs in electronic diary (up to 7 days after vaccination)
Adverse Event Reporting Description SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
 
Arm/Group Title MCV4+Tdap+rLP2086 MCV4+Tdap+Saline Saline+Saline+rLP2086
Hide Arm/Group Description Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule. Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule. Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
All-Cause Mortality
MCV4+Tdap+rLP2086 MCV4+Tdap+Saline Saline+Saline+rLP2086
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
MCV4+Tdap+rLP2086 MCV4+Tdap+Saline Saline+Saline+rLP2086
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/883 (1.70%)   9/870 (1.03%)   11/875 (1.26%) 
Congenital, familial and genetic disorders       
Adrenogenital syndrome * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Congenital spinal cord anomaly * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Gastrointestinal disorders       
Pancreatitis acute * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Infections and infestations       
Appendicitis * 1  1/883 (0.11%)  0/870 (0.00%)  1/875 (0.11%) 
Bone abscess * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Gastroenteritis * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Influenza * 1  0/883 (0.00%)  1/870 (0.11%)  0/875 (0.00%) 
Pneumonia * 1  0/883 (0.00%)  1/870 (0.11%)  0/875 (0.00%) 
Pneumonia viral * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Tooth abscess * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Injury, poisoning and procedural complications       
Concussion * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Epiphyseal fracture * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Excoriation * 1  0/883 (0.00%)  1/870 (0.11%)  0/875 (0.00%) 
Joint injury * 1  0/883 (0.00%)  1/870 (0.11%)  0/875 (0.00%) 
Radius fracture * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Wound secretion * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Metabolism and nutrition disorders       
Type 1 diabetes mellitus * 1  0/883 (0.00%)  1/870 (0.11%)  1/875 (0.11%) 
Diabetic ketoacidosis * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Hyperglycaemia * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Musculoskeletal and connective tissue disorders       
Bone cyst * 1  0/883 (0.00%)  1/870 (0.11%)  0/875 (0.00%) 
Scoliosis * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Nervous system disorders       
Convulsion * 1  0/883 (0.00%)  1/870 (0.11%)  1/875 (0.11%) 
Dural arteriovenous fistula * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Hemiplegic migraine * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Migraine * 1  0/883 (0.00%)  1/870 (0.11%)  0/875 (0.00%) 
Syncope * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Cerebrovascular accident * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Psychiatric disorders       
Affective disorder * 1  1/883 (0.11%)  1/870 (0.11%)  0/875 (0.00%) 
Depression suicidal * 1  0/883 (0.00%)  1/870 (0.11%)  0/875 (0.00%) 
Disorientation * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Encopresis * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Post-traumatic stress disorder * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Psychogenic seizure * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Pneumomediastinum * 1  0/883 (0.00%)  0/870 (0.00%)  1/875 (0.11%) 
Vascular disorders       
Haemorrhage * 1  1/883 (0.11%)  0/870 (0.00%)  0/875 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
MCV4+Tdap+rLP2086 MCV4+Tdap+Saline Saline+Saline+rLP2086
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   277/883 (31.37%)   260/870 (29.89%)   292/875 (33.37%) 
Gastrointestinal disorders       
Vomiting * 1  18/883 (2.04%)  21/870 (2.41%)  19/875 (2.17%) 
Nausea * 1  10/883 (1.13%)  9/870 (1.03%)  14/875 (1.60%) 
Abdominal pain * 1  2/883 (0.23%)  7/870 (0.80%)  10/875 (1.14%) 
General disorders       
Injection site pain * 1  19/883 (2.15%)  21/870 (2.41%)  15/875 (1.71%) 
Pyrexia * 1  20/883 (2.27%)  14/870 (1.61%)  17/875 (1.94%) 
Infections and infestations       
Upper respiratory tract infection * 1  47/883 (5.32%)  61/870 (7.01%)  70/875 (8.00%) 
Pharyngitis * 1  38/883 (4.30%)  27/870 (3.10%)  28/875 (3.20%) 
Pharyngitis streptococcal * 1  23/883 (2.60%)  20/870 (2.30%)  30/875 (3.43%) 
Nasopharyngitis * 1  22/883 (2.49%)  19/870 (2.18%)  16/875 (1.83%) 
Gastroenteritis viral * 1  15/883 (1.70%)  15/870 (1.72%)  25/875 (2.86%) 
Gastroenteritis * 1  15/883 (1.70%)  20/870 (2.30%)  16/875 (1.83%) 
Sinusitis * 1  18/883 (2.04%)  13/870 (1.49%)  17/875 (1.94%) 
Otitis media * 1  17/883 (1.93%)  11/870 (1.26%)  14/875 (1.60%) 
Bronchitis * 1  5/883 (0.57%)  6/870 (0.69%)  15/875 (1.71%) 
Viral infection * 1  4/883 (0.45%)  7/870 (0.80%)  12/875 (1.37%) 
Conjunctivitis * 1  9/883 (1.02%)  6/870 (0.69%)  3/875 (0.34%) 
Otitis externa * 1  17/883 (1.93%)  11/870 (1.26%)  14/875 (1.60%) 
Injury, poisoning and procedural complications       
Fall * 1  12/883 (1.36%)  13/870 (1.49%)  16/875 (1.83%) 
Ligament sprain * 1  12/883 (1.36%)  12/870 (1.38%)  13/875 (1.49%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity * 1  9/883 (1.02%)  4/870 (0.46%)  8/875 (0.91%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Skin papilloma * 1  9/883 (1.02%)  2/870 (0.23%)  3/875 (0.34%) 
Nervous system disorders       
Headache * 1  24/883 (2.72%)  29/870 (3.33%)  26/875 (2.97%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  26/883 (2.94%)  20/870 (2.30%)  31/875 (3.54%) 
Oropharyngeal pain * 1  17/883 (1.93%)  13/870 (1.49%)  23/875 (2.63%) 
Nasal congestion * 1  4/883 (0.45%)  5/870 (0.57%)  11/875 (1.26%) 
Rhinitis allergic * 1  6/883 (0.68%)  4/870 (0.46%)  10/875 (1.14%) 
Asthma * 1  6/883 (0.68%)  4/870 (0.46%)  9/875 (1.03%) 
Skin and subcutaneous tissue disorders       
Dermatitis contact * 1  11/883 (1.25%)  1/870 (0.11%)  5/875 (0.57%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v 17.1
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.
 
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01461980    
Other Study ID Numbers: B1971015
6108A1-2005 ( Other Identifier: Alias Study Number )
First Submitted: September 28, 2011
First Posted: October 28, 2011
Results First Submitted: May 7, 2015
Results First Posted: May 25, 2015
Last Update Posted: December 20, 2018