Trial Outcomes & Findings for Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine (NCT NCT00862277)
NCT ID: NCT00862277
Last Updated: 2016-04-14
Results Overview
Recruitment status
COMPLETED
Target enrollment
763 participants
Primary outcome timeframe
Day 0
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from 16 December 2008 to 16 March 2009 in 21 medical centers in the US.
A total of 763 participants who met the inclusion and exclusion criteria were enrolled. One participant withdrew before sampling and is excluded from analysis and this report.
Participant milestones
| Measure |
Group 1: Menactra® From Previous Studies
Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
|
Group 2: Menomune® From Previous Study
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
|
Group 3: Control
Meningococcal vaccine-naive, age-matched participants
|
|---|---|---|---|
|
Overall Study
STARTED
|
561
|
96
|
105
|
|
Overall Study
COMPLETED
|
560
|
94
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
5
|
Reasons for withdrawal
| Measure |
Group 1: Menactra® From Previous Studies
Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
|
Group 2: Menomune® From Previous Study
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
|
Group 3: Control
Meningococcal vaccine-naive, age-matched participants
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
5
|
Baseline Characteristics
Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
Baseline characteristics by cohort
| Measure |
Group 1: Menactra® From Previous Studies
n=561 Participants
Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
|
Group 2: Menomune® From Previous Study
n=96 Participants
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
|
Group 3: Control
n=105 Participants
Meningococcal vaccine-naive, age-matched participants
|
Total
n=762 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
205 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
262 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
356 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
500 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
|
19.1 Years
STANDARD_DEVIATION 2.87 • n=5 Participants
|
23.3 Years
STANDARD_DEVIATION 2.17 • n=7 Participants
|
19.3 Years
STANDARD_DEVIATION 3.98 • n=5 Participants
|
19.7 Years
STANDARD_DEVIATION 3.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
264 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
377 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
297 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
385 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
561 participants
n=5 Participants
|
96 participants
n=7 Participants
|
105 participants
n=5 Participants
|
762 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
Outcome measures
| Measure |
Group 1: Menactra® From Previous Studies
n=559 Participants
Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
|
Group 2: Menomune® From Previous Study
n=94 Participants
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
|
Group 3: Control
n=100 Participants
Meningococcal vaccine-naive, age-matched participants
|
|---|---|---|---|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup Y ≥ 128 [n = 558, 93, 99]
|
85 Percentage of Participants
|
77 Percentage of Participants
|
62 Percentage of Participants
|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup A ≥ 8, [n = 557, 93, 99]
|
53 Percentage of Participants
|
34 Percentage of Participants
|
20 Percentage of Participants
|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup A ≥ 128, [n = 557, 93, 99]
|
50 Percentage of Participants
|
29 Percentage of Participants
|
17 Percentage of Participants
|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup C ≥ 8 [n = 557, 92, 99]
|
39 Percentage of Participants
|
28 Percentage of Participants
|
16 Percentage of Participants
|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup C ≥ 128 [n = 557, 92, 99]
|
31 Percentage of Participants
|
22 Percentage of Participants
|
12 Percentage of Participants
|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup Y ≥ 8 [n = 558, 93, 99]
|
91 Percentage of Participants
|
83 Percentage of Participants
|
72 Percentage of Participants
|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup W-135 ≥ 8 [n = 556, 92, 99]
|
84 Percentage of Participants
|
64 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
Serogroup W-135 ≥128 [n = 556, 92, 99]
|
77 Percentage of Participants
|
55 Percentage of Participants
|
47 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Serum Bactericidal Assay Baby Rabbit Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
Outcome measures
| Measure |
Group 1: Menactra® From Previous Studies
n=559 Participants
Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
|
Group 2: Menomune® From Previous Study
n=94 Participants
Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
|
Group 3: Control
n=100 Participants
Meningococcal vaccine-naive, age-matched participants
|
|---|---|---|---|
|
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Serogroup C [n = 557, 92, 99]
|
24.9 Titers
Interval 20.1 to 30.7
|
16.9 Titers
Interval 9.91 to 28.7
|
8.58 Titers
Interval 5.86 to 12.6
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Serogroup A [n = 557, 93, 99]
|
74.0 Titers
Interval 58.2 to 94.2
|
19.1 Titers
Interval 11.7 to 31.2
|
11.0 Titers
Interval 7.08 to 17.0
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Serogroup Y [n=558, 93, 99]
|
369 Titers
Interval 317.0 to 430.0
|
183 Titers
Interval 121.0 to 277.0
|
84.1 Titers
Interval 54.9 to 129.0
|
|
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
Serogroup W-135 [n = 556, 92, 99]
|
246 Titers
Interval 205.0 to 295.0
|
59.4 Titers
Interval 37.6 to 93.8
|
38.7 Titers
Interval 23.6 to 63.3
|
Adverse Events
Group 1: Menactra® From Previous Studies
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Menomune® From Previous Study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER