Trial Outcomes & Findings for Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents (NCT NCT00777790)
NCT ID: NCT00777790
Last Updated: 2014-02-14
Results Overview
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
241 participants
Primary outcome timeframe
Day 0 and 8 and 28 days post-vaccination
Results posted on
2014-02-14
Participant Flow
Subjects were recruited from 20 February 2004 to 08 April 2004 at 9 medical clinics in the US.
A total of 241 subjects that met the inclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Menactra® Group
Subjects that received Menactra® vaccine in Study MTA02
|
Menomune® Group
Subjects that received Menomune® vaccine in Study MTA02
|
Control Group
Meningococcal vaccine-naïve subjects
|
|---|---|---|---|
|
Overall Study
STARTED
|
76
|
77
|
88
|
|
Overall Study
COMPLETED
|
76
|
77
|
88
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
Baseline characteristics by cohort
| Measure |
Menactra® Group
n=76 Participants
Subjects that received Menactra® vaccine in Study MTA02
|
Menomune® Group
n=77 Participants
Subjects that received Menomune® vaccine in Study MTA02
|
Control Group
n=88 Participants
Meningococcal vaccine-naïve subjects
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 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
|
16.6 years
STANDARD_DEVIATION 1.91 • n=5 Participants
|
16.8 years
STANDARD_DEVIATION 1.85 • n=7 Participants
|
15.7 years
STANDARD_DEVIATION 1.97 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 1.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
77 participants
n=7 Participants
|
88 participants
n=5 Participants
|
241 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 and 8 and 28 days post-vaccinationPopulation: GMT results were on the per-protocol population for immunogenicity.
Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.
Outcome measures
| Measure |
Menactra® Group
n=71 Participants
Subjects that received Menactra® vaccine in Study MTA02
|
Menomune® Group
n=72 Participants
Subjects that received Menomune® vaccine in Study MTA02
|
Control Group
n=84 Participants
Meningococcal vaccine-naïve subjects
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup C (Day 8)
|
17888.7 Titer
Interval 14004.2 to 22850.7
|
1149.4 Titer
Interval 692.8 to 1907.0
|
7003.3 Titer
Interval 4979.4 to 9849.7
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup Y (Day 8)
|
13088.9 Titer
Interval 9486.0 to 18060.2
|
3098.2 Titer
Interval 2170.0 to 4423.4
|
7061.3 Titer
Interval 5029.8 to 9913.2
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup W-135 (Day 28)
|
4882.9 Titer
Interval 3712.1 to 6422.9
|
1625.5 Titer
Interval 1250.6 to 2112.8
|
3018.3 Titer
Interval 2369.7 to 3844.4
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup Y (Day 0)
|
570.0 Titer
Interval 353.9 to 918.3
|
398.6 Titer
Interval 259.8 to 611.7
|
204.3 Titer
Interval 131.4 to 317.8
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup A (Day 0)
|
1075.2 Titer
Interval 763.6 to 1514.1
|
193.6 Titer
Interval 113.7 to 329.9
|
83.3 Titer
Interval 47.3 to 146.8
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup Y (Day 28)
|
5821.0 Titer
Interval 4140.6 to 8183.3
|
2489.6 Titer
Interval 1786.5 to 3469.3
|
4411.8 Titer
Interval 3117.8 to 6242.7
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup W-135 (Day 0)
|
451.0 Titer
Interval 300.2 to 677.4
|
126.8 Titer
Interval 80.0 to 200.9
|
23.0 Titer
Interval 15.7 to 33.7
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup W-135 (Day 8)
|
9861.6 Titer
Interval 7442.9 to 13066.4
|
2008.9 Titer
Interval 1516.2 to 2661.9
|
6036.6 Titer
Interval 4555.5 to 7999.3
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup A (Day 8)
|
9300.5 Titer
Interval 7539.3 to 11473.2
|
4423.9 Titer
Interval 3272.7 to 5980.0
|
12897.1 Titer
Interval 9908.1 to 16787.9
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup A (Day 28)
|
4300.9 Titer
Interval 3408.5 to 5427.0
|
3219.9 Titer
Interval 2413.6 to 4295.5
|
6239.2 Titer
Interval 4922.7 to 7907.8
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup C (Day 0)
|
246.2 Titer
Interval 139.2 to 435.5
|
124.4 Titer
Interval 65.9 to 234.8
|
39.7 Titer
Interval 24.1 to 65.2
|
|
Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.
Serogroup C (Day 28)
|
8601.8 Titer
Interval 6552.2 to 11292.6
|
664.0 Titer
Interval 396.3 to 1112.5
|
2802.3 Titer
Interval 1932.3 to 4063.9
|
Adverse Events
Menactra® Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Menomune® Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Menactra® Group
n=76 participants at risk
Subjects that received Menactra® vaccine in Study MTA02
|
Menomune® Group
n=77 participants at risk
Subjects that received Menomune® vaccine in Study MTA02
|
Control Group
n=88 participants at risk
Meningococcal vaccine-naïve subjects
|
|---|---|---|---|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.3%
1/76 • Number of events 1 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
3.9%
3/77 • Number of events 3 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
5.7%
5/88 • Number of events 5 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.9%
6/76 • Number of events 6 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
2.6%
2/77 • Number of events 3 • Adverse events data were collected from the day of vaccination for 28 days post-vaccination.
|
4.5%
4/88 • Number of events 4 • Adverse events data were collected from the day of vaccination for 28 days 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