Trial Outcomes & Findings for A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India (NCT NCT01086969)
NCT ID: NCT01086969
Last Updated: 2012-02-06
Results Overview
Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
Baseline and 21 days post-vaccination
Results posted on
2012-02-06
Participant Flow
Participants were enrolled from 11 June to 01 October 2010 in 3 clinical centers in India.
A total of 300 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Age 2 to 11 Years Group
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
Participants aged 18 to 55 years at enrollment
|
|---|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
100
|
|
Overall Study
COMPLETED
|
99
|
98
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Age 2 to 11 Years Group
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
Participants aged 18 to 55 years at enrollment
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
Baseline Characteristics
A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
Baseline characteristics by cohort
| Measure |
Age 2 to 11 Years Group
n=100 Participants
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
n=100 Participants
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
n=100 Participants
Participants aged 18 to 55 years at enrollment
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
7.2 Years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
14.2 Years
STANDARD_DEVIATION 1.4 • n=7 Participants
|
34.8 Years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
18.7 Years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 21 days post-vaccinationPopulation: Menactra vaccine antibody titers were determined in the immunogenicity analysis set.
Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Outcome measures
| Measure |
Age 2 to 11 Years Group
n=100 Participants
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
n=100 Participants
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
n=100 Participants
Participants aged 18 to 55 years at enrollment
|
|---|---|---|---|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup C (Post-vaccination; N= 99, 98, 100)
|
91 Participants
|
95 Participants
Interval 0.0 to 0.0
|
99 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup Y (Pre-vaccination; N= 100, 100, 100)
|
92 Participants
|
92 Participants
Interval 0.0 to 0.0
|
89 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup Y (Post-vaccination; N= 99, 97, 98)
|
99 Participants
|
97 Participants
Interval 0.0 to 0.0
|
98 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup C (Pre-vaccination; N= 100, 100, 100)
|
24 Participants
|
43 Participants
Interval 0.0 to 0.0
|
66 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup W-135 (Pre-vaccination; N=100, 100, 100)
|
54 Participants
|
68 Participants
Interval 0.0 to 0.0
|
52 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup W-135 (Post-vaccination; N= 99, 97, 99)
|
96 Participants
|
97 Participants
Interval 0.0 to 0.0
|
99 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup A (Pre-vaccination; N= 100, 100, 100)
|
17 Participants
|
27 Participants
Interval 0.0 to 0.0
|
23 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Serogroup A (Post-vaccination; N= 99, 97, 98)
|
95 Participants
|
94 Participants
Interval 0.0 to 0.0
|
97 Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 0 and Day 30 post-vaccinationPopulation: Geometric mean titers were determined in the immunogenicity analysis set
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Outcome measures
| Measure |
Age 2 to 11 Years Group
n=100 Participants
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
n=100 Participants
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
n=100 Participants
Participants aged 18 to 55 years at enrollment
|
|---|---|---|---|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup A (Pre-vaccination; N= 100, 100, 100)
|
9.51 1/dilution (1/dil)
Interval 6.43 to 14.1
|
15.0 1/dilution (1/dil)
Interval 9.65 to 23.4
|
9.78 1/dilution (1/dil)
Interval 6.9 to 13.9
|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup A (Post-vaccination; N= 99, 97, 98)
|
1145 1/dilution (1/dil)
Interval 854.0 to 1536.0
|
1324 1/dilution (1/dil)
Interval 1002.0 to 1750.0
|
2261 1/dilution (1/dil)
Interval 1749.0 to 2924.0
|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup C (Pre-vaccination; N= 100, 100, 100)
|
9.92 1/dilution (1/dil)
Interval 7.01 to 14.0
|
17.9 1/dilution (1/dil)
Interval 12.2 to 26.2
|
56.9 1/dilution (1/dil)
Interval 36.6 to 88.3
|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup C (Post-vaccination; N= 99, 98, 100)
|
610 1/dilution (1/dil)
Interval 392.0 to 949.0
|
2343 1/dilution (1/dil)
Interval 1563.0 to 3512.0
|
7486 1/dilution (1/dil)
Interval 5380.0 to 10417.0
|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup W-135 (Pre-vaccination; N=100, 100, 100)
|
31.3 1/dilution (1/dil)
Interval 20.6 to 47.7
|
47.8 1/dilution (1/dil)
Interval 32.3 to 70.9
|
28.6 1/dilution (1/dil)
Interval 18.6 to 44.1
|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup W-135 (Post-vaccination; N= 99, 97, 99)
|
1756 1/dilution (1/dil)
Interval 1240.0 to 2486.0
|
2538 1/dilution (1/dil)
Interval 1947.0 to 3307.0
|
3183 1/dilution (1/dil)
Interval 2360.0 to 4293.0
|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup Y (Pre-vaccination; N= 100, 100, 100)
|
355 1/dilution (1/dil)
Interval 256.0 to 491.0
|
309 1/dilution (1/dil)
Interval 222.0 to 430.0
|
156 1/dilution (1/dil)
Interval 110.0 to 222.0
|
|
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Serogroup Y (Post-vaccination; N= 99, 97, 98)
|
1964 1/dilution (1/dil)
Interval 1607.0 to 2399.0
|
3190 1/dilution (1/dil)
Interval 2502.0 to 4067.0
|
3926 1/dilution (1/dil)
Interval 2855.0 to 5398.0
|
PRIMARY outcome
Timeframe: Day 0 to 30 post-vaccinationPopulation: Four-fold antibody increase were determined in the immunogenicity analysis set
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Outcome measures
| Measure |
Age 2 to 11 Years Group
n=100 Participants
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
n=100 Participants
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
n=100 Participants
Participants aged 18 to 55 years at enrollment
|
|---|---|---|---|
|
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Serogroup C (N = 99, 98, 100)
|
88 Percentage of Participants
|
91 Percentage of Participants
Interval 0.0 to 0.0
|
96 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Serogroup Y (N = 99, 97, 98)
|
68 Percentage of Participants
|
75 Percentage of Participants
Interval 0.0 to 0.0
|
89 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Serogroup W-135 (N = 99, 97, 99)
|
93 Percentage of Participants
|
96 Percentage of Participants
Interval 0.0 to 0.0
|
97 Percentage of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Serogroup A (N = 99, 97, 98)
|
85 Percentage of Participants
|
85 Percentage of Participants
Interval 0.0 to 0.0
|
96 Percentage of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 0 to 7 post-vaccinationPopulation: Safety parameters were assessed in the safety analysis set
Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia
Outcome measures
| Measure |
Age 2 to 11 Years Group
n=100 Participants
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
n=100 Participants
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
n=100 Participants
Participants aged 18 to 55 years at enrollment
|
|---|---|---|---|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Grade 3 pain (Incapacitating)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Any Solicited injection site erythema
|
7 Participants
|
1 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Any Solicited injection site swelling
|
10 Participants
|
4 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Any Solicited fever
|
11 Participants
|
3 Participants
Interval 0.0 to 0.0
|
5 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Grade 3 fever (≥ 39.0°C)
|
3 Participants
|
2 Participants
Interval 0.0 to 0.0
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Any Solicited headache
|
12 Participants
|
19 Participants
Interval 0.0 to 0.0
|
19 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Grade 3 headache (significant)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Grade 3 malaise (significant)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Any Solicited myalgia
|
13 Participants
|
8 Participants
Interval 0.0 to 0.0
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Grade 3 myalgia (significant)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Any Solicited injection site pain
|
30 Participants
|
23 Participants
Interval 0.0 to 0.0
|
38 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Grade 3 erythema (≥5 cm [2-11 years] or >10 cm)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Grade 3 swelling (≥5 cm [2-11 years] or >10 cm)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Any Solicited malaise
|
9 Participants
|
13 Participants
Interval 0.0 to 0.0
|
5 Participants
Interval 0.0 to 0.0
|
Adverse Events
Age 2 to 11 Years Group
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Age 12 to 17 Years Group
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Age 18 to 55 Years Group
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Age 2 to 11 Years Group
n=100 participants at risk
Participants at age 2 to 11 years on enrollment.
|
Age 12 to 17 Years Group
n=100 participants at risk
Participants aged 12 to 17 years at enrollment.
|
Age 18 to 55 Years Group
n=100 participants at risk
Participants aged 18 to 55 years at enrollment
|
|---|---|---|---|
|
General disorders
Fever
|
11.0%
11/100 • Number of events 11 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
3.0%
3/100 • Number of events 3 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
5.0%
5/100 • Number of events 5 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
|
Nervous system disorders
Headache
|
12.0%
12/100 • Number of events 12 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
19.0%
19/100 • Number of events 19 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
19.0%
19/100 • Number of events 19 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
|
General disorders
Malaise
|
9.0%
9/100 • Number of events 9 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
13.0%
13/100 • Number of events 13 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
5.0%
5/100 • Number of events 5 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.0%
13/100 • Number of events 13 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
8.0%
8/100 • Number of events 8 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
12.0%
12/100 • Number of events 12 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
|
General disorders
Injection site pain
|
30.0%
30/100 • Number of events 30 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
23.0%
23/100 • Number of events 23 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
38.0%
38/100 • Number of events 38 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
|
General disorders
Injection site erythema
|
7.0%
7/100 • Number of events 7 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
1.0%
1/100 • Number of events 1 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
0.00%
0/100 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
|
General disorders
Injection site swelling
|
10.0%
10/100 • Number of events 10 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
4.0%
4/100 • Number of events 4 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
0.00%
0/100 • Adverse events data were collected from the day of vaccination (Day 0) to up to 6 months post vaccination
|
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