Trial Outcomes & Findings for Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine (NCT NCT01442675)
NCT ID: NCT01442675
Last Updated: 2014-11-18
Results Overview
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
834 participants
Primary outcome timeframe
Day 28 post-vaccination
Results posted on
2014-11-18
Participant Flow
The study participants were enrolled from 26 September 2011 through 21 December 2011 at 15 clinic centers in the United States.
A total of 834 participants who met all of the inclusion and none of the exclusion criteria were randomized; 831 were vaccinated in this study.
Participant milestones
| Measure |
Menactra® Vaccine Group
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
|
|---|---|
|
Overall Study
STARTED
|
834
|
|
Overall Study
Safety Analysis Set
|
831
|
|
Overall Study
Per-Protocol Analysis Set
|
781
|
|
Overall Study
COMPLETED
|
822
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Menactra® Vaccine Group
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
|
|---|---|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine
Baseline characteristics by cohort
| Measure |
Menactra® Vaccine Group
n=834 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Age, Categorical
<=18 years
|
592 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
242 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Age Continuous
|
17.8 Years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
434 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
400 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
834 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 post-vaccinationPopulation: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set.
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)
Outcome measures
| Measure |
Menactra® Vaccine Group
n=781 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup A
|
776 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup C
|
778 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup Y
|
779 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup W-135
|
780 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccinationPopulation: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=781 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 0 pre-vaccination; N=781)
|
675 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 6 post-vaccination; N=112)
|
110 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 28 post-vaccination; N=781)
|
781 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 0 pre-vaccination; N=781)
|
443 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 6 post-vaccination; N=112)
|
112 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 28 post-vaccination; N=781)
|
780 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 0 pre-vaccination; N=781)
|
389 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 6 post-vaccination; N=112)
|
111 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 28 post-vaccination; N=781)
|
780 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 0 pre-vaccination; N=781)
|
604 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 6 post-vaccination; N=112)
|
111 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 28 post-vaccination; N=781)
|
780 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccinationPopulation: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=781 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 0 pre-vaccination; N=781)
|
504 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 6 post-vaccination; N=112)
|
110 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 28 post-vaccination; N=781)
|
776 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 0 pre-vaccination; N=781)
|
345 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 6 post-vaccination; N=112)
|
111 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 28 post-vaccination; N=781)
|
778 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 0 pre-vaccination; N=781)
|
302 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 6 post-vaccination; N=112)
|
111 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 28 post-vaccination; N=781)
|
779 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 0 pre-vaccination; N=781)
|
535 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 6 post-vaccination; N=112)
|
111 Participants
|
|
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 28 post-vaccination; N=781)
|
780 Participants
|
SECONDARY outcome
Timeframe: Day 6 and Day 28 post-vaccinationPopulation: SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=781 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup A (Day 6 post-vaccination; N=112)
|
97 Participants
|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup A (Day 28 post-vaccination; N=781)
|
742 Participants
|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup C (Day 6 post-vaccination; N=112)
|
102 Participants
|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup C (Day 28 post-vaccination; N=781)
|
744 Participants
|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup Y (Day 6 post-vaccination; N=112)
|
106 Participants
|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup Y (Day 28 post-vaccination; N=781)
|
758 Participants
|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup W-135 (Day 6 post-vaccination; N=112)
|
103 Participants
|
|
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup W-135 (Day 28 post-vaccination; N=781)
|
750 Participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccinationPopulation: Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point.
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=781 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 0 pre-vaccination; N=781)
|
8.9 Titers
Interval 8.3 to 9.6
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 6 post-vaccination; N=112)
|
227.6 Titers
Interval 166.4 to 311.3
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A (Day 28 post-vaccination; N=781)
|
421.2 Titers
Interval 378.8 to 468.3
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 0 pre-vaccination; N=781)
|
8.8 Titers
Interval 7.8 to 10.0
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 6 post-vaccination; N=112)
|
639.8 Titers
Interval 457.4 to 895.0
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C (Day 28 post-vaccination; N=781)
|
1135 Titers
Interval 1013.0 to 1271.8
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 0 pre-vaccination; N=781)
|
6.2 Titers
Interval 5.6 to 6.9
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 6 post-vaccination; N=112)
|
655.8 Titers
Interval 474.8 to 905.9
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y (Day 28 post-vaccination; N=781)
|
1303.6 Titers
Interval 1183.1 to 1436.4
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 0 pre-vaccination; N=781)
|
13.8 Titers
Interval 12.4 to 15.3
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 6 post-vaccination; N=112)
|
702 Titers
Interval 508.0 to 970.2
|
|
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135 (Day 28 post-vaccination; N=781)
|
1271.6 Titers
Interval 1145.3 to 1411.8
|
SECONDARY outcome
Timeframe: Day 6 and Day 28 post-vaccinationPopulation: Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point.
Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=781 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup A (Day 6 post-vaccination; N=112)
|
30.5 Titers ratio
Interval 21.8 to 42.5
|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup A (Day 28 post-vaccination; N=781)
|
47.2 Titers ratio
Interval 42.3 to 52.7
|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup C (Day 6 post-vaccination; N=112)
|
64 Titers ratio
Interval 42.7 to 95.9
|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup C (Day 28 post-vaccination; N=781)
|
128.3 Titers ratio
Interval 112.0 to 147.0
|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup Y (Day 6 post-vaccination; N=112)
|
121.1 Titers ratio
Interval 84.5 to 173.5
|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup Y (Day 28 post-vaccination; N=781)
|
209.1 Titers ratio
Interval 184.4 to 237.1
|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup W-135 (Day 6 post-vaccination; N=112)
|
45.5 Titers ratio
Interval 31.0 to 67.0
|
|
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup W-135 (Day 28 post-vaccination; N=781)
|
92.4 Titers ratio
Interval 81.1 to 105.4
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - \>100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=831 Participants
Participants \<56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
|
|---|---|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Injection-site Pain (N=821)
|
494 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Injection-site Pain (N=821)
|
20 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Injection-site Erythema (N=821)
|
10 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Injection-site Erythema (N=821)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Injection-site Swelling (N=821)
|
14 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Injection-site Swelling (N=821)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Fever (N=817)
|
6 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Fever (N=817)
|
0 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Headache (N=822)
|
317 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Headache (N=822)
|
22 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Malaise (N=822)
|
242 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Malaise (N=822)
|
23 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Myalgia (N=822)
|
352 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Myalgia (N=822)
|
19 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Shivering (N=822)
|
102 Participants
|
|
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®
Grade 3 Shivering (N=822)
|
6 Participants
|
Adverse Events
Menactra® Vaccine Group
Serious events: 11 serious events
Other events: 494 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menactra® Vaccine Group
n=831 participants at risk
Participants \<56 years of age who received Menactra 4-6 years previously at age \>= 11 years received a single dose of Menactra vaccine
|
|---|---|
|
Infections and infestations
Bronchitis
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Infections and infestations
Appendicitis
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Infections and infestations
Serratia infection
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Injury, poisoning and procedural complications
Injury
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hydatidiform mole
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Psychiatric disorders
Affective disorder
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Psychiatric disorders
Depression
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.24%
2/831 • Number of events 2 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Renal and urinary disorders
Post streptococcal glomerulonephritis
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.12%
1/831 • Number of events 1 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
Other adverse events
| Measure |
Menactra® Vaccine Group
n=831 participants at risk
Participants \<56 years of age who received Menactra 4-6 years previously at age \>= 11 years received a single dose of Menactra vaccine
|
|---|---|
|
General disorders
Injection site Pain
|
60.2%
494/821 • Number of events 494 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Nervous system disorders
Headache
|
38.6%
317/822 • Number of events 317 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
General disorders
Malaise
|
29.4%
242/822 • Number of events 242 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.8%
352/822 • Number of events 352 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
|
General disorders
Shivering
|
12.4%
102/822 • Number of events 102 • Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
|
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