Trial Outcomes & Findings for Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years (NCT NCT00329901)
NCT ID: NCT00329901
Last Updated: 2014-06-18
Results Overview
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1072 participants
Primary outcome timeframe
1 month after vaccination (Day 29)
Results posted on
2014-06-18
Participant Flow
Subjects were recruited from 14 centers in Italy.
All enrolled subjects participated in the trial.
Participant milestones
| Measure |
Tdap + MenACWY-CRM
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap + Saline
Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Overall Study
STARTED
|
361
|
354
|
357
|
|
Overall Study
COMPLETED
|
352
|
349
|
353
|
|
Overall Study
NOT COMPLETED
|
9
|
5
|
4
|
Reasons for withdrawal
| Measure |
Tdap + MenACWY-CRM
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap + Saline
Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
|
Overall Study
Unable to classify
|
2
|
2
|
0
|
Baseline Characteristics
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Baseline characteristics by cohort
| Measure |
Tdap + MenACWY-CRM
n=361 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap + Saline
n=354 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
n=357 Participants
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
Total
n=1072 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 3.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
518 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
554 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on the per-protocol population i.e all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding
To demonstrate that the immunogenicity of one injection of Tdap vaccine, concomitantly administered with MenACWY-CRM vaccine, is not inferior to that of one injection of Tdap vaccine, concomitantly administered with saline placebo, in terms of 1. the percentage of subjects with antibody levels against diphtheria toxin ≥ 1.0 IU/mL and against tetanus toxin ≥ 1.0 IU/mL and 2. the percentage of subjects with at least 4 fold increase in antibody levels against pertussis toxin (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) at 1 month after immunization, as measured by enzyme linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=350 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=345 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (diphtheria)
|
4 Percentages of subjects
Interval 2.0 to 7.0
|
5 Percentages of subjects
Interval 3.0 to 7.0
|
—
|
|
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (diphtheria)
|
94 Percentages of subjects
Interval 91.0 to 96.0
|
85 Percentages of subjects
Interval 80.0 to 88.0
|
—
|
|
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (tetanus )
|
25 Percentages of subjects
Interval 20.0 to 30.0
|
36 Percentages of subjects
Interval 31.0 to 42.0
|
—
|
|
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (tetanus )
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
99 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
|
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (PT) 4-fold increase (N=286, 287)
|
76 Percentages of subjects
Interval 70.0 to 80.0
|
81 Percentages of subjects
Interval 76.0 to 85.0
|
—
|
|
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (FHA)4-fold increase (N=286, 287)
|
83 Percentages of subjects
Interval 78.0 to 87.0
|
86 Percentages of subjects
Interval 82.0 to 90.0
|
—
|
|
Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (PRN) 4-fold increase (N=285, 287)
|
84 Percentages of subjects
Interval 79.0 to 88.0
|
91 Percentages of subjects
Interval 87.0 to 94.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on per-protocol population.
The percentage of subjects with anti-diphtheria and anti-tetanus concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=350 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=345 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (diphtheria)
|
55 Percentages of subjects
Interval 50.0 to 60.0
|
63 Percentages of subjects
Interval 57.0 to 68.0
|
—
|
|
Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (diphtheria)
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 98.0 to 100.0
|
—
|
|
Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (tetanus)
|
97 Percentages of subjects
Interval 95.0 to 99.0
|
97 Percentages of subjects
Interval 95.0 to 99.0
|
—
|
|
Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (tetanus)
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
100 Percentages of subjects
Interval 99.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on per-protocol population.
The geometric mean concentrations of antibodies ≥ 0.1 IU/mL against diphtheria, tetanus and pertussis (PT, FHA and PRN) antigens in subjects, as measured by ELISA, following concomitant administration of Tdap with MenACWY-CRM as compared to when Tdap given concomitantly with saline placebo.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=350 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=345 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (diptheria)
|
0.11 IU/mL
Interval 0.085 to 0.14
|
0.12 IU/mL
Interval 0.096 to 0.16
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (diptheria)
|
7.96 IU/mL
Interval 6.19 to 10.0
|
2.77 IU/mL
Interval 2.15 to 3.57
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (tetanus)
|
0.62 IU/mL
Interval 0.5 to 0.76
|
0.75 IU/mL
Interval 0.61 to 0.92
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (tetanus)
|
12 IU/mL
Interval 9.84 to 14.0
|
15 IU/mL
Interval 13.0 to 18.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (PT ) (N=286,287)
|
2.68 IU/mL
Interval 1.97 to 3.66
|
2.85 IU/mL
Interval 2.1 to 3.86
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (PT) (N=286,287)
|
62 IU/mL
Interval 52.0 to 74.0
|
79 IU/mL
Interval 66.0 to 93.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (FHA) (N=286,287)
|
15 IU/mL
Interval 13.0 to 18.0
|
17 IU/mL
Interval 14.0 to 20.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (FHA) (N=286,287)
|
186 IU/mL
Interval 165.0 to 209.0
|
219 IU/mL
Interval 194.0 to 246.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 1 (PRN) (N=285,287)
|
6.45 IU/mL
Interval 5.18 to 8.03
|
8.7 IU/mL
Interval 7.01 to 11.0
|
—
|
|
Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo
Day 29 (PRN) (N=285,287)
|
157 IU/mL
Interval 131.0 to 189.0
|
254 IU/mL
Interval 211.0 to 304.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on per-protocol population.
The geometric mean ratios (GMRs- day 29/day 1) of post-vaccination versus pre- vaccination antibody concentrations against diptheria, tetanus and pertussis (PT, FHA and PRN) antigens following concomitant administration of Tdap vaccine with MenACWY-CRM vaccine as compared to when Tdap was given concomitantly with saline placebo.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=350 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=345 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
diphtheria
|
72 Ratio
Interval 58.0 to 91.0
|
22 Ratio
Interval 18.0 to 28.0
|
—
|
|
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
tetanus
|
19 Ratio
Interval 14.0 to 25.0
|
20 Ratio
Interval 15.0 to 26.0
|
—
|
|
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
PT (N=286,287)
|
23 Ratio
Interval 18.0 to 30.0
|
28 Ratio
Interval 21.0 to 36.0
|
—
|
|
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
FHA (N=286,287)
|
12 Ratio
Interval 10.0 to 14.0
|
13 Ratio
Interval 11.0 to 15.0
|
—
|
|
Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo
PRN (N=285,287)
|
24 Ratio
Interval 20.0 to 30.0
|
29 Ratio
Interval 24.0 to 35.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on per-protocol population.
The percentage of subjects with serum bactericidal antibody titers(hSBA) ≥ 1:4 and ≥ 1:8 against Neisseria meningitidis serogroups A,C,W and Y,following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. The serum bactericidal antibodies directed against N.meningitidis serogroup A, C, W and Y, are measured by human complement Serum Bactericidal Assay (hSBA).
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=119 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=126 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men A) hSBA ≥ 1:4
|
3 Percentages of subjects
Interval 1.0 to 7.0
|
5 Percentages of subjects
Interval 2.0 to 10.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men A) hSBA ≥ 1:4
|
79 Percentages of subjects
Interval 71.0 to 86.0
|
83 Percentages of subjects
Interval 75.0 to 89.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men C) hSBA ≥ 1:4 (N=118,124)
|
36 Percentages of subjects
Interval 28.0 to 46.0
|
30 Percentages of subjects
Interval 22.0 to 39.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men C) hSBA ≥ 1:4 (N=118,124)
|
94 Percentages of subjects
Interval 88.0 to 98.0
|
90 Percentages of subjects
Interval 84.0 to 95.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men W) hSBA ≥ 1:4 (N=116,124)
|
57 Percentages of subjects
Interval 47.0 to 66.0
|
56 Percentages of subjects
Interval 47.0 to 65.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men W) hSBA ≥ 1:4 (N=116,124)
|
97 Percentages of subjects
Interval 93.0 to 99.0
|
97 Percentages of subjects
Interval 92.0 to 99.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men Y) hSBA ≥ 1:4 (N=117,125)
|
47 Percentages of subjects
Interval 38.0 to 56.0
|
42 Percentages of subjects
Interval 33.0 to 51.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men Y) hSBA ≥ 1:4 (N=117,125)
|
96 Percentages of subjects
Interval 90.0 to 99.0
|
97 Percentages of subjects
Interval 92.0 to 99.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men A) hSBA ≥ 1:8
|
2 Percentages of subjects
Interval 0.0 to 6.0
|
4 Percentages of subjects
Interval 1.0 to 9.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men A) hSBA ≥ 1:8
|
74 Percentages of subjects
Interval 65.0 to 82.0
|
80 Percentages of subjects
Interval 72.0 to 87.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men C) hSBA ≥ 1:8 (N=118,124)
|
25 Percentages of subjects
Interval 17.0 to 33.0
|
25 Percentages of subjects
Interval 18.0 to 34.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men C) hSBA ≥ 1:8 (N=118,124)
|
92 Percentages of subjects
Interval 86.0 to 96.0
|
88 Percentages of subjects
Interval 81.0 to 93.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men W) hSBA ≥ 1:8 (N=116,124)
|
53 Percentages of subjects
Interval 43.0 to 62.0
|
56 Percentages of subjects
Interval 46.0 to 65.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men W) hSBA ≥ 1:8 (N=116,124)
|
96 Percentages of subjects
Interval 90.0 to 99.0
|
97 Percentages of subjects
Interval 92.0 to 99.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men Y) hSBA ≥ 1:8 (N=117,125)
|
38 Percentages of subjects
Interval 30.0 to 48.0
|
38 Percentages of subjects
Interval 29.0 to 47.0
|
—
|
|
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men Y) hSBA ≥ 1:8 (N=117,125)
|
93 Percentages of subjects
Interval 87.0 to 97.0
|
94 Percentages of subjects
Interval 89.0 to 98.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on per-protocol population.
The hSBA geometric mean titers (GMTs) against N.meningitidis serogroups A,C,W and Y, at baseline and at one month, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine, as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=119 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=126 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men A)
|
2.14 Titers
Interval 1.99 to 2.31
|
2.21 Titers
Interval 2.05 to 2.38
|
—
|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men A)
|
34 Titers
Interval 23.0 to 50.0
|
50 Titers
Interval 34.0 to 74.0
|
—
|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men C) N=118,124
|
4 Titers
Interval 3.23 to 4.96
|
3.92 Titers
Interval 3.16 to 4.86
|
—
|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men C) N=118,124
|
89 Titers
Interval 58.0 to 136.0
|
92 Titers
Interval 60.0 to 140.0
|
—
|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men W) N=116,124
|
11 Titers
Interval 7.7 to 15.0
|
9.49 Titers
Interval 6.93 to 13.0
|
—
|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men W) N=116,124
|
73 Titers
Interval 54.0 to 98.0
|
77 Titers
Interval 57.0 to 103.0
|
—
|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 1 (Men Y) N=117,125
|
5.38 Titers
Interval 4.2 to 6.89
|
5 Titers
Interval 3.91 to 6.39
|
—
|
|
The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Day 29 (Men Y) N=117,125
|
73 Titers
Interval 54.0 to 98.0
|
70 Titers
Interval 52.0 to 94.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on per-protocol population.
The geometric mean ratios (GMRs-day 29/day1)of post-vaccination versus pre- vaccination hSBA titers against N.meningitidis serogroups A,C,W and Y, when MenACWY-CRM vaccine is concomitantly administered with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=119 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=126 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men A
|
16 Ratios
Interval 11.0 to 23.0
|
23 Ratios
Interval 16.0 to 33.0
|
—
|
|
Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men C (N=118,124)
|
22 Ratios
Interval 15.0 to 33.0
|
23 Ratios
Interval 16.0 to 35.0
|
—
|
|
Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men W (N=116,124)
|
6.9 Ratios
Interval 4.84 to 9.85
|
8.09 Ratios
Interval 5.69 to 12.0
|
—
|
|
Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men Y (N=117,125)
|
14 Ratios
Interval 9.41 to 19.0
|
14 Ratios
Interval 9.79 to 20.0
|
—
|
SECONDARY outcome
Timeframe: 1 month after vaccination (Day 29)Population: Analysis was done on per-protocol population.
The percentage of subjects showing an hSBA seroresponse against N.meningitidis serogroups A,C,W and Y, following concomitant administration of MenACWY-CRM vaccine with Tdap vaccine as compared to when MenACWY-CRM was given concomitantly with saline placebo. Seroresponse to MenACWY-CRM is defined as a pre-vaccination hSBA titer \< 1:4 to a post-vaccination hSBA titer of ≥ 1:8 or a pre-vaccination hSBA titer ≥ 1:4 to a post-vaccination titer of at least four times the baseline hSBA titer.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=119 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=126 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men A
|
74 Percentages of subjects
Interval 65.0 to 82.0
|
80 Percentages of subjects
Interval 72.0 to 87.0
|
—
|
|
Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men C (N=118, 124)
|
82 Percentages of subjects
Interval 74.0 to 89.0
|
78 Percentages of subjects
Interval 70.0 to 85.0
|
—
|
|
Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men W (N=116, 124)
|
58 Percentages of subjects
Interval 48.0 to 67.0
|
59 Percentages of subjects
Interval 50.0 to 68.0
|
—
|
|
Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo
Men Y (N=117, 125)
|
70 Percentages of subjects
Interval 61.0 to 78.0
|
70 Percentages of subjects
Interval 61.0 to 78.0
|
—
|
SECONDARY outcome
Timeframe: Day 1-7 after any vaccinationPopulation: Analysis was done on the safety population
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when MenACWY-CRM vaccine was concomitantly administered with saline placebo.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=359 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=357 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Local
|
278 Participants
|
179 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Injection site pain (MenACWY) site 1
|
82 Participants
|
116 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Injection site erythema (MenACWY) site 1
|
48 Participants
|
66 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Injection site induration (MenACWY) site 1
|
41 Participants
|
59 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Injection site pain (Tdap or saline) site 2
|
246 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Injection site erythema (Tdap or saline) site 2
|
103 Participants
|
37 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Injection site induration (Tdap or saline) site 2
|
118 Participants
|
23 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Systemic
|
198 Participants
|
171 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Chills
|
39 Participants
|
47 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Nausea
|
43 Participants
|
28 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Malaise
|
65 Participants
|
43 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Myalgia
|
118 Participants
|
79 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Arthralgia
|
57 Participants
|
40 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Headache
|
129 Participants
|
128 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Fever ≥ 38°C
|
11 Participants
|
14 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Other
|
42 Participants
|
33 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Stayed home due to reaction (N=358,357)
|
12 Participants
|
12 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo
Analgesic Antipyretic medication used
|
38 Participants
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1-7 after any vaccinationPopulation: Analysis was done on the safety population
The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine and Tdap vaccine as compared to when Tdap was concomitantly administered with saline placebo
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=359 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=353 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Local
|
278 Participants
|
282 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Injection site pain (Tdap) site 2
|
227 Participants
|
246 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Injection site erythema (Tdap) site 2
|
103 Participants
|
103 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Injection site induration (Tdap) site 2
|
110 Participants
|
118 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Injection site pain (MenACWY or saline) site 1
|
82 Participants
|
41 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Injection site erythema (MenACWY or saline) site 1
|
48 Participants
|
34 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Injection site induration(MenACWY or saline)site1
|
41 Participants
|
27 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Systemic
|
198 Participants
|
202 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Chills
|
39 Participants
|
41 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Nausea
|
43 Participants
|
35 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Malaise
|
65 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Myalgia
|
118 Participants
|
127 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Arthralgia
|
57 Participants
|
60 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Headache
|
129 Participants
|
110 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Fever ≥ 38°C
|
11 Participants
|
7 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Other
|
42 Participants
|
39 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Stayed home due to reaction (N=358,353)
|
12 Participants
|
15 Participants
|
—
|
|
Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo
Analgesic Antipyretic medication used
|
38 Participants
|
38 Participants
|
—
|
SECONDARY outcome
Timeframe: Throughout the study (Day 1 to Day 181)Population: This analysis was done on the safety population.
The number of subjects reporting any unsolicited adverse events (AEs) when Tdap is concomitantly administered with MenACWY-CRM as compared to when MenACWY-CRM vaccine or Tdap vaccine was concomitantly administered with saline placebo.
Outcome measures
| Measure |
Tdap+MenACWY-CRM
n=359 Participants
Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
|
Tdap+Saline
n=353 Participants
Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
|
MenACWY-CRM + Saline
n=357 Participants
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Any AE (Day 1 to 29)
|
43 Participants
|
31 Participants
|
48 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Possibly/probably related AE (Day 1 to 29)
|
8 Participants
|
6 Participants
|
6 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Serious AEs (Day 1 to 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
AE's leading to discontinuation (Day 1 to 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Possibly/probably related SAE(Day 1 to 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Death ( Day 1 to 29)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Any AE (Day 30 to 181)
|
42 Participants
|
36 Participants
|
39 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Possibly/probably related AE (Day 30 to 181)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Serious AEs (Day 30 to 181)
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
AE's leading to discontinuation (Day 30 to 181)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Possibly/probably related SAE (Day 30 to 181)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo
Death (Day 30 to 181)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Tdap + MenACWY-CRM
Serious events: 1 serious events
Other events: 297 other events
Deaths: 0 deaths
Tdap + Saline
Serious events: 2 serious events
Other events: 309 other events
Deaths: 0 deaths
MenACWY-CRM + Saline
Serious events: 0 serious events
Other events: 238 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tdap + MenACWY-CRM
n=359 participants at risk
Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
|
Tdap + Saline
n=353 participants at risk
Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
|
MenACWY-CRM + Saline
n=357 participants at risk
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
0.28%
1/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
0.00%
0/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.28%
1/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
0.00%
0/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
0.00%
0/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
0.28%
1/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
0.00%
0/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
Other adverse events
| Measure |
Tdap + MenACWY-CRM
n=359 participants at risk
Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
|
Tdap + Saline
n=353 participants at risk
Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
|
MenACWY-CRM + Saline
n=357 participants at risk
Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.3%
44/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
10.8%
38/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
8.7%
31/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
General disorders
Chills
|
10.9%
39/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
11.6%
41/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
13.2%
47/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
General disorders
Injection site erythema
|
33.1%
119/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
31.2%
110/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
23.2%
83/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
General disorders
Injection site induration
|
34.8%
125/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
37.1%
131/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
20.2%
72/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
General disorders
Injection site pain
|
72.1%
259/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
74.2%
262/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
38.9%
139/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
General disorders
Malaise
|
18.7%
67/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
16.1%
57/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
12.0%
43/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
General disorders
Pyrexia
|
5.8%
21/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
4.0%
14/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
5.9%
21/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.9%
57/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
17.0%
60/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
11.2%
40/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.1%
119/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
36.3%
128/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
22.4%
80/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
|
Nervous system disorders
Headache
|
36.5%
131/359 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
32.0%
113/353 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
38.1%
136/357 • All serious adverse events were collected throughout the study (Day 1-181). All solicited events were collected from Day 1-7 post vaccination; unsolicited adverse events were collected from Day 1-181.
There were 3 subjects who withdrew consent (2 subjects in the Tdap+MenACWY-CRM group and 1 subject in the Tdap+Saline group) prior to visit one of the study and thus were not included in the safety analyses for this section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60