Trial Outcomes & Findings for Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine (NCT NCT00777257)
NCT ID: NCT00777257
Last Updated: 2014-02-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1345 participants
Primary outcome timeframe
Day 0 to Day 28 post-vaccination
Results posted on
2014-02-14
Participant Flow
Study participants were enrolled from 26 April 2005 through 24 June 2005 in 21 Medical centers in the US
A total of 1345 participants that met the inclusion and exclusion criteria were randomized and vaccinated.
Participant milestones
| Measure |
Tdap + Placebo Vaccines Day 0
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
|---|---|---|---|
|
Overall Study
STARTED
|
444
|
450
|
451
|
|
Overall Study
COMPLETED
|
433
|
438
|
442
|
|
Overall Study
NOT COMPLETED
|
11
|
12
|
9
|
Reasons for withdrawal
| Measure |
Tdap + Placebo Vaccines Day 0
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
2
|
|
Overall Study
Protocol Violation
|
2
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
6
|
5
|
Baseline Characteristics
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
Baseline characteristics by cohort
| Measure |
Tdap + Placebo Vaccines Day 0
n=444 Participants
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
n=450 Participants
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
n=451 Participants
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
Total
n=1345 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
444 Participants
n=5 Participants
|
450 Participants
n=7 Participants
|
451 Participants
n=5 Participants
|
1345.0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0.0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0.0 Participants
n=4 Participants
|
|
Age, Continuous
|
13.0 years
STANDARD_DEVIATION 1.87 • n=5 Participants
|
13.0 years
STANDARD_DEVIATION 1.93 • n=7 Participants
|
13.3 years
STANDARD_DEVIATION 2.05 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 1.95 • n=4 Participants
|
|
Sex: Female, Male
Female
|
220 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
599.0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
224 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
746.0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
444 participants
n=5 Participants
|
450 participants
n=7 Participants
|
451 participants
n=5 Participants
|
1345.0 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28 post-vaccinationPopulation: Serum bactericidal activity using baby rabbit complement (SBA-BR) titers for each meningococcal serogroup was evaluated in the per-protocol population
Outcome measures
| Measure |
Tdap + Placebo Vaccines Day 0
n=376 Participants
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
n=382 Participants
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
n=382 Participants
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
|---|---|---|---|
|
Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Meningococcal Serogroup A
|
92 Percentage of participants
|
94 Percentage of participants
|
93 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Meningococcal Serogroup C
|
80 Percentage of participants
|
84 Percentage of participants
|
87 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Meningococcal Serogroup Y
|
79 Percentage of participants
|
87 Percentage of participants
|
87 Percentage of participants
|
|
Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.
Meningococcal Serogroup W-135
|
94 Percentage of participants
|
96 Percentage of participants
|
96 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 post-vaccinationPopulation: Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.
Outcome measures
| Measure |
Tdap + Placebo Vaccines Day 0
n=377 Participants
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
n=384 Participants
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
n=383 Participants
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Diphtheria toxoid - Day 0
|
0.2 IU/mL
Interval 0.2 to 0.3
|
0.3 IU/mL
Interval 0.3 to 0.3
|
56.2 IU/mL
Interval 48.9 to 64.6
|
|
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Diphtheria toxoid - Day 28
|
7.9 IU/mL
Interval 7.0 to 8.8
|
49.8 IU/mL
Interval 43.8 to 56.7
|
38.2 IU/mL
Interval 33.3 to 43.9
|
|
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Tetanus toxoid - Day 0
|
0.9 IU/mL
Interval 0.8 to 0.9
|
0.8 IU/mL
Interval 0.8 to 0.9
|
1.0 IU/mL
Interval 0.9 to 1.1
|
|
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Tetanus toxoid - Day 28
|
22.8 IU/mL
Interval 21.0 to 24.7
|
16.4 IU/mL
Interval 15.2 to 17.5
|
21.1 IU/mL
Interval 19.6 to 22.7
|
PRIMARY outcome
Timeframe: Day 0 and Day 28 Post-vaccinationPopulation: Geometric mean concentration for each vaccine antigen was evaluated in the per-protocol population.
Outcome measures
| Measure |
Tdap + Placebo Vaccines Day 0
n=377 Participants
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
n=384 Participants
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
n=383 Participants
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
|---|---|---|---|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Pertussis Toxoid - Day 0
|
15.3 EU/mL
Interval 13.3 to 17.5
|
14.0 EU/mL
Interval 12.2 to 16.0
|
20.7 EU/mL
Interval 18.0 to 23.9
|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Pertussis Toxoid - Day 28
|
88.0 EU/mL
Interval 79.8 to 97.1
|
73.4 EU/mL
Interval 67.0 to 80.3
|
107.4 EU/mL
Interval 97.6 to 118.2
|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Filamentous Haemagglutinin - Day 0
|
21.4 EU/mL
Interval 18.9 to 24.3
|
20.0 EU/mL
Interval 17.9 to 22.3
|
28.5 EU/mL
Interval 25.4 to 31.9
|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Filamentous Haemagglutinin - Day 28
|
179.5 EU/mL
Interval 163.2 to 197.6
|
140.2 EU/mL
Interval 128.0 to 153.6
|
245.1 EU/mL
Interval 226.4 to 265.2
|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Pertactin - Day 0
|
9.0 EU/mL
Interval 7.9 to 10.3
|
8.4 EU/mL
Interval 7.4 to 9.5
|
11.9 EU/mL
Interval 10.4 to 13.6
|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Pertactin - Day 28
|
176.5 EU/mL
Interval 156.6 to 199.0
|
130.3 EU/mL
Interval 116.5 to 145.9
|
213.6 EU/mL
Interval 192.8 to 236.6
|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Fimbriae Types 2 and 3 - Day 0
|
13.8 EU/mL
Interval 12.0 to 15.9
|
12.7 EU/mL
Interval 11.1 to 14.6
|
14.2 EU/mL
Interval 12.2 to 16.6
|
|
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.
Fimbriae Types 2 and 3 - Day 28
|
1133.4 EU/mL
Interval 979.3 to 1311.7
|
699.1 EU/mL
Interval 602.9 to 810.7
|
832.3 EU/mL
Interval 712.0 to 972.8
|
SECONDARY outcome
Timeframe: 0 to 7 days post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants intend-to-treat population
Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.
Outcome measures
| Measure |
Tdap + Placebo Vaccines Day 0
n=444 Participants
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
n=450 Participants
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
n=451 Participants
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
|---|---|---|---|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Solicited Inj. Site Reaction-Tdap, Dose 1
|
10 Percentage of participants
|
9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Erythyma (Dose 1)
|
0 Percentage of participants
|
19 Percentage of participants
|
16 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any swelling (Dose 1)
|
11 Percentage of participants
|
0 Percentage of participants
|
15 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Solicited Inj. Site Reaction-Placebo, Dose 1
|
1 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Pain (Dose 1)
|
33 Percentage of participants
|
0 Percentage of participants
|
52 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Pain (Incapacitating, Dose 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Solicited Inj. Site Reaction (Dose 2)
|
4 Percentage of participants
|
8 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Erythyma (Dose 2)
|
13 Percentage of participants
|
8 Percentage of participants
|
14 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Erythema (≥ 2 inches, Dose 2)
|
2 Percentage of participants
|
1 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any swelling (Dose 2)
|
11 Percentage of participants
|
6 Percentage of participants
|
14 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 swelling (≥ 2 inches, Dose 2)
|
2 Percentage of participants
|
0 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Pain (Dose 2)
|
51 Percentage of participants
|
20 Percentage of participants
|
65 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 swelling (≥ 2 inches, Dose 1)
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Solicited Injection Site Reaction-Tdap, Dose 1
|
87 Percentage of participants
|
84 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Erythema (≥ 2 inches, Dose 1)
|
1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Solicited Inj. Site Reaction-Menactra, Dose 1
|
0 Percentage of participants
|
57 Percentage of participants
|
58 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Solicited Inj Site Reaction-Menactra, Dose 1
|
0 Percentage of participants
|
4 Percentage of participants
|
4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Solicited Inj. Site Reaction-Placebo, Dose 1
|
38 Percentage of participants
|
0 Percentage of participants
|
35 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Solicited Injection Site Reaction (Dose 2)
|
56 Percentage of participants
|
24 Percentage of participants
|
68 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Pain (Incapacitating, Dose 2)
|
2 Percentage of participants
|
1 Percentage of participants
|
5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Solicited Systemic Reaction (Dose 1)
|
74 Percentage of participants
|
69 Percentage of participants
|
61 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Solicited Systemic Reaction (Dose 1)
|
5 Percentage of participants
|
7 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Fever (Dose 1)
|
2 Percentage of participants
|
4 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Fever (≥ 40.0 °C, Dose 1)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Headache (Dose 1)
|
37 Percentage of participants
|
38 Percentage of participants
|
37 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Headache (prevents daily activities, Dose 1)
|
2 Percentage of participants
|
4 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Malaise (Dose 1)
|
30 Percentage of participants
|
30 Percentage of participants
|
25 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Malaise (prevents daily activities, Dose 1)
|
3 Percentage of participants
|
4 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Myalgia (Dose 1)
|
60 Percentage of participants
|
54 Percentage of participants
|
41 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Myalgia (prevents daily activities, Dose 1)
|
2 Percentage of participants
|
2 Percentage of participants
|
2 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Solicited Systemic Reaction (Dose 2)
|
48 Percentage of participants
|
33 Percentage of participants
|
54 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Solicited Systemic Reaction (Dose 2)
|
4 Percentage of participants
|
3 Percentage of participants
|
6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Fever (Dose 2)
|
1 Percentage of participants
|
1 Percentage of participants
|
1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grade 3 Fever (≥ 40.0 °C, Dose 2)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Headache (Dose 2)
|
27 Percentage of participants
|
22 Percentage of participants
|
26 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Headache (prevents daily activities, Dose 2)
|
3 Percentage of participants
|
2 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Malaise (Dose 2)
|
19 Percentage of participants
|
13 Percentage of participants
|
20 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Malaise (prevents daily activities, Dose 2)
|
3 Percentage of participants
|
1 Percentage of participants
|
3 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Any Myalgia (Dose 2)
|
29 Percentage of participants
|
15 Percentage of participants
|
44 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.
Grd 3 Myalgia (prevents daily activities, Dose 2)
|
1 Percentage of participants
|
1 Percentage of participants
|
3 Percentage of participants
|
Adverse Events
Tdap + Placebo Vaccines Day 0
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Tdap + Menactra® Vaccines Day 0
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Menactra® + Placebo Vaccines Day 0
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tdap + Placebo Vaccines Day 0
n=444 participants at risk
Participants received Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
|
Tdap + Menactra® Vaccines Day 0
n=450 participants at risk
Participants received Tdap vaccine + Menactra® vaccine concomitantly on Day 0; and Placebo vaccine 28 days later
|
Menactra® + Placebo Vaccines Day 0
n=451 participants at risk
Participants received Menactra® vaccine + placebo vaccine concomitantly on Day 0; Tdap vaccine 28 days later.
|
|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.23%
1/444 • Number of events 1 • Adverse event data were collected over 2 months post-dose 1 vaccination
|
0.00%
0/450 • Adverse event data were collected over 2 months post-dose 1 vaccination
|
0.00%
0/451 • Adverse event data were collected over 2 months post-dose 1 vaccination
|
|
Nervous system disorders
Convulsion
|
0.23%
1/444 • Number of events 1 • Adverse event data were collected over 2 months post-dose 1 vaccination
|
0.22%
1/450 • Number of events 1 • Adverse event data were collected over 2 months post-dose 1 vaccination
|
0.22%
1/451 • Number of events 1 • Adverse event data were collected over 2 months post-dose 1 vaccination
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER