Trial Outcomes & Findings for Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation (NCT NCT01890759)
NCT ID: NCT01890759
Last Updated: 2022-04-19
Results Overview
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Day 0 (pre-vaccination) and Day 28 post-second vaccination
Results posted on
2022-04-19
Participant Flow
Study participants were enrolled from 25 June 2013 to 05 November 2013 (Russian Federation) and 24 March 2015 to 17 November 2015 (India) at 4 clinic sites in Russia and 4 clinic sites in India.
A total of 300 participants (100 in Russia and 200 in India) were enrolled. Of the 100 Russians, 2 did not receive the second vaccination. Of the 200 Indians, 1 did not receive the first vaccination and 8 did not receive the second vaccination.
Participant milestones
| Measure |
Russian Federation
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
200
|
|
Overall Study
COMPLETED
|
98
|
188
|
|
Overall Study
NOT COMPLETED
|
2
|
12
|
Reasons for withdrawal
| Measure |
Russian Federation
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
8
|
Baseline Characteristics
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
Baseline characteristics by cohort
| Measure |
Russian Federation
n=100 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=200 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
Age Continuous
|
13.5 Months
STANDARD_DEVIATION 2.7 • n=5 Participants
|
12.9 Months
STANDARD_DEVIATION 3.0 • n=7 Participants
|
13.1 Months
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
100 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
0 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-second vaccinationPopulation: Seroprotection was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=77,169)
|
45.5 Percentage of participants
|
55.0 Percentage of participants
|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,166)
|
98.7 Percentage of participants
|
97.6 Percentage of participants
|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=77,169)
|
6.5 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,169)
|
92.2 Percentage of participants
|
95.9 Percentage of participants
|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=77,169)
|
5.2 Percentage of participants
|
6.5 Percentage of participants
|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,169)
|
96.1 Percentage of participants
|
98.2 Percentage of participants
|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Pre vaccination 1 (N=77,169)
|
7.8 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Post vaccination 2 (N=77,169)
|
100.0 Percentage of participants
|
99.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: The threshold was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=77,169)
|
19.5 Percentage of participants
|
14.2 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=77,169)
|
88.3 Percentage of participants
|
97.6 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,166)
|
100.0 Percentage of participants
|
99.4 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,169)
|
98.7 Percentage of participants
|
98.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=77,169)
|
9.1 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,169)
|
98.7 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Pre vaccination 1 (N=77,169)
|
14.3 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Post vaccination 2 (N=77,169)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: The threshold was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup A (N=77,166)
|
90.9 Percentage of participants
|
84.9 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup C (N=77,169)
|
76.6 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup Y (N=77,169)
|
90.9 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold 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 (N=77,169)
|
90.9 Percentage of participants
|
97.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: The threshold was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=77,169)
|
45.5 Percentage of participants
|
55.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,166)
|
98.7 Percentage of participants
|
97.6 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,169)
|
96.1 Percentage of participants
|
98.2 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=77,169)
|
6.5 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,169)
|
92.2 Percentage of participants
|
95.9 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=77,169)
|
5.2 Percentage of participants
|
6.5 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Pre vaccination 1 (N=77,169)
|
7.8 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Post vaccination 2 (N=77,169)
|
100.0 Percentage of participants
|
99.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Threshold was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=75,165)
|
25.3 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,166)
|
97.4 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Post vaccination 2 (N=77,163)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,161)
|
100.0 Percentage of participants
|
98.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=76,166)
|
5.3 Percentage of participants
|
10.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=76,166)
|
84.2 Percentage of participants
|
84.3 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,164)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Pre vaccination 1 (N=76,165)
|
27.6 Percentage of participants
|
18.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: The threshold was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,169)
|
98.7 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,166)
|
100.0 Percentage of participants
|
99.4 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=77,169)
|
88.3 Percentage of participants
|
97.6 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=77,169)
|
19.5 Percentage of participants
|
14.2 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,169)
|
98.7 Percentage of participants
|
98.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=77,169)
|
9.1 Percentage of participants
|
11.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Pre vaccination 1 (N=77,169)
|
14.3 Percentage of participants
|
10.7 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Post vaccination 2 (N=77,169)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: The threshold was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,166)
|
97.4 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=75,165)
|
26.7 Percentage of participants
|
5.5 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,161)
|
100.0 Percentage of participants
|
98.8 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=76,166)
|
5.3 Percentage of participants
|
11.4 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=76,166)
|
84.2 Percentage of participants
|
84.3 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,164)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Pre vaccination 1 (N=76,165)
|
27.6 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Serogroup W-135; Post vaccination 2 (N=77,163)
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: The threshold was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup Y (N=77,169)
|
90.9 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup A (N=77,166)
|
90.9 Percentage of participants
|
84.9 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup C (N=77,169)
|
76.6 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Serogroup W 135 (N=77,169)
|
90.9 Percentage of participants
|
97.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Seroprotection was assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Serogroup A (N=75,158)
|
96.0 Percentage of participants
|
96.8 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Serogroup C (N=76,163)
|
94.7 Percentage of participants
|
92.0 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Serogroup Y (N=76,161)
|
68.4 Percentage of participants
|
66.5 Percentage of participants
|
|
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Serogroup W 135 (N=76,159)
|
96.1 Percentage of participants
|
96.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean titers were assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=77,169)
|
5.73 Titers (1/dil)
Interval 4.92 to 6.68
|
6.82 Titers (1/dil)
Interval 5.94 to 7.83
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=77,169)
|
2.46 Titers (1/dil)
Interval 2.2 to 2.75
|
2.50 Titers (1/dil)
Interval 2.18 to 2.86
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,166)
|
171 Titers (1/dil)
Interval 126.0 to 232.0
|
95.2 Titers (1/dil)
Interval 77.4 to 117.0
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,169)
|
49.3 Titers (1/dil)
Interval 33.8 to 71.8
|
128 Titers (1/dil)
Interval 102.0 to 160.0
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=77,169)
|
2.35 Titers (1/dil)
Interval 2.04 to 2.72
|
2.49 Titers (1/dil)
Interval 2.16 to 2.86
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,169)
|
54.9 Titers (1/dil)
Interval 41.3 to 73.0
|
104 Titers (1/dil)
Interval 84.8 to 128.0
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Pre vaccination 1 (N=77,169)
|
2.57 Titers (1/dil)
Interval 2.15 to 3.08
|
2.45 Titers (1/dil)
Interval 2.12 to 2.82
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Post vaccination 2 (N=77,169)
|
114 Titers (1/dil)
Interval 92.3 to 140.0
|
201 Titers (1/dil)
Interval 167.0 to 241.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean titers were assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Pre vaccination 1 (N=76,165)
|
5.66 Titers (1/dil)
Interval 3.77 to 8.49
|
4.44 Titers (1/dil)
Interval 3.4 to 5.8
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135; Post vaccination 2 (N=77,163)
|
1260 Titers (1/dil)
Interval 967.0 to 1640.0
|
1134 Titers (1/dil)
Interval 913.0 to 1409.0
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Pre vaccination 1 (N=75,165)
|
6.47 Titers (1/dil)
Interval 3.93 to 10.6
|
2.55 Titers (1/dil)
Interval 2.16 to 3.02
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A; Post vaccination 2 (N=77,161)
|
1940 Titers (1/dil)
Interval 1612.0 to 2336.0
|
1426 Titers (1/dil)
Interval 1165.0 to 1746.0
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Pre vaccination 1 (N=76,166)
|
2.38 Titers (1/dil)
Interval 2.0 to 2.82
|
3.27 Titers (1/dil)
Interval 2.62 to 4.09
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C; Post vaccination 2 (N=77,166)
|
326 Titers (1/dil)
Interval 240.0 to 444.0
|
781 Titers (1/dil)
Interval 577.0 to 1057.0
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Pre vaccination 1 (N=76,166)
|
87.3 Titers (1/dil)
Interval 55.5 to 137.0
|
95.2 Titers (1/dil)
Interval 71.7 to 126.0
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y; Post vaccination 2 (N=77,164)
|
734 Titers (1/dil)
Interval 618.0 to 872.0
|
805 Titers (1/dil)
Interval 669.0 to 968.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Serogroup A (N=77,166)
|
29.8 Titer ratios
Interval 21.4 to 41.5
|
13.9 Titer ratios
Interval 10.8 to 18.1
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Serogroup C (N=77,169)
|
20.0 Titer ratios
Interval 13.8 to 29.2
|
51.3 Titer ratios
Interval 39.4 to 66.8
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Serogroup Y (N=77,169)
|
23.4 Titer ratios
Interval 16.6 to 32.8
|
41.9 Titer ratios
Interval 32.8 to 53.6
|
|
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Serogroup W 135 (N=77,169)
|
44.2 Titer ratios
Interval 32.7 to 59.8
|
82.2 Titer ratios
Interval 65.4 to 103.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Outcome measures
| Measure |
Russian Federation
n=77 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=169 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup A (N=75,158)
|
305 Titer ratios
Interval 182.0 to 512.0
|
540 Titer ratios
Interval 416.0 to 700.0
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup C (N=76,163)
|
140 Titer ratios
Interval 97.4 to 202.0
|
240 Titer ratios
Interval 168.0 to 344.0
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup Y (N=76,161)
|
8.45 Titer ratios
Interval 5.5 to 13.0
|
8.50 Titer ratios
Interval 6.01 to 12.0
|
|
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Serogroup W 135 (N=76,159)
|
223 Titer ratios
Interval 137.0 to 365.0
|
246 Titer ratios
Interval 177.0 to 342.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-each vaccinationPopulation: Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.
Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, \>39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
Outcome measures
| Measure |
Russian Federation
n=100 Participants
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=199 Participants
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Drowsiness; Post dose 1; N=100,199
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Fever; Post dose 1; N=100,197
|
0 Percentage of participants
|
7.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Fever; Post dose 1; N=100,197
|
0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Vomiting; Post dose 1; N=100,199
|
2.0 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Vomiting; Post dose 1; N=100,199
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Crying abnormal; Post dose 1; N=100,199
|
8.0 Percentage of participants
|
12.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Crying abnormal; Post dose 1; N=100,199
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Drowsiness; Post dose 1; N=100,199
|
14.0 Percentage of participants
|
9.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Appetite lost; Post dose 1; N=100,199
|
14.0 Percentage of participants
|
17.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Appetite lost; Post dose 1; N=100,199
|
0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Irritability; Post dose 1; N=100,199
|
23.0 Percentage of participants
|
14.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Irritability; Post dose 1; N=100,199
|
0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Fever; Post dose 2; N=98,185
|
6.1 Percentage of participants
|
7.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Fever; Post dose 2; N=98,185
|
0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Irritability; Post dose 2; N=98,188
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Vomiting; Post dose 2; N=98,188
|
0 Percentage of participants
|
7.4 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Vomiting; Post dose 2; N=98,188
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Crying abnormal; Post dose 2; N=98,188
|
9.2 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Crying abnormal; Post dose 2; N=98,188
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Drowsiness; Post dose 2; N=98,188
|
11.2 Percentage of participants
|
3.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Drowsiness; Post dose 2; N=98,188
|
1.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Appetite lost; Post dose 2; N=98,188
|
11.2 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Appetite lost; Post dose 2; N=98,188
|
1.0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Irritability; Post dose 2; N=98,188
|
12.2 Percentage of participants
|
9.0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Inj. site Tenderness; Post dose 1; N=100,199
|
13.0 Percentage of participants
|
14.6 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Inj. site Tenderness;Post dose 1;N=100,199
|
0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Inj. site Erythema; Post dose 1; N=100,199
|
28.0 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Inj. site Erythema; Post dose 1; N=100,199
|
1.0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Inj. site Swelling; Post dose 1; N=100,199
|
8.0 Percentage of participants
|
3.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Inj. site Swelling; Post dose 1; N=100,199
|
0 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Inj. site Tenderness; Post dose 2; N=98,188
|
13.3 Percentage of participants
|
10.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Inj. site Tenderness;Post dose 2;N=98,188
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Inj. site Erythema; Post dose 2; N=98,188
|
16.3 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Inj. site Erythema; Post dose 2; N=98,188
|
2.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Any Inj. site Swelling; Post dose 2; N=98,188
|
7.1 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Grade 3 Inj. site Swelling; Post dose 2; N=98,188
|
1.0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Russian Federation
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
India
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Russian Federation
n=100 participants at risk
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=199 participants at risk
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/100 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/100 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
1/100 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
0.00%
0/199 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/100 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
0.50%
1/199 • Number of events 1 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
Other adverse events
| Measure |
Russian Federation
n=100 participants at risk
Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
India
n=199 participants at risk
Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection.
|
|---|---|---|
|
General disorders
Injection site Tenderness
|
24.0%
24/100 • Number of events 24 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
20.1%
40/199 • Number of events 40 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
General disorders
Injection site Erythema
|
35.0%
35/100 • Number of events 35 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
6.0%
12/199 • Number of events 12 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
General disorders
Injection site Swelling
|
13.0%
13/100 • Number of events 13 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
5.0%
10/199 • Number of events 10 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
General disorders
Fever
|
6.0%
6/100 • Number of events 6 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
12.6%
25/199 • Number of events 25 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Psychiatric disorders
Crying abnormal
|
15.0%
15/100 • Number of events 15 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
16.6%
33/199 • Number of events 33 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Nervous system disorders
Drowsiness
|
22.0%
22/100 • Number of events 22 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
12.1%
24/199 • Number of events 24 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Metabolism and nutrition disorders
Appetite lost
|
21.0%
21/100 • Number of events 21 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
20.1%
40/199 • Number of events 40 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Psychiatric disorders
Irritability
|
29.0%
29/100 • Number of events 29 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
17.1%
34/199 • Number of events 34 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/100 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
5.0%
10/199 • Number of events 11 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/100 • Number of events 2 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
15.1%
30/199 • Number of events 30 • Adverse event data were collected from Day 0 up to Day 28 post-each vaccination and SAEs were collected throughout the study.
|
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