Trial Outcomes & Findings for Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier (NCT NCT02633787)
NCT ID: NCT02633787
Last Updated: 2016-11-07
Results Overview
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
Pre-booster vaccination, 28 days, and 4 years post-booster vaccination
Results posted on
2016-11-07
Participant Flow
Study participants were enrolled from 15 December 2015 to 28 December 2015 at 4 clinic sites in the United States.
A total of 110 participants who met all inclusion and none of the exclusion criteria were enrolled; 109 participants completed the trial.
Participant milestones
| Measure |
All Subjects; Menactra Vaccine
Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
109
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Subjects; Menactra Vaccine
Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier
Baseline characteristics by cohort
| Measure |
All Subjects; Menactra Vaccine
n=110 Participants
Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
110 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
22.2 Years
STANDARD_DEVIATION 3.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-booster vaccination, 28 days, and 4 years post-booster vaccinationPopulation: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Outcome measures
| Measure |
All Subjects; Menactra Vaccine
n=109 Participants
Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
|
|---|---|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup A; Pre-booster (N=108)
|
88.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup A; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup A; 4 years post-booster (N=109)
|
98.2 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup C; Pre-booster (N=108)
|
67.6 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup C; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup C; 4 years post-booster (N=109)
|
89.9 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup Y; Pre-booster (N=108)
|
57.4 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup Y; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup Y; 4 years post-booster (N=109)
|
98.2 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup W-135; Pre-booster (N=108)
|
83.3 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup W-135; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Serogroup W-135; 4 years post-booster (N=109)
|
97.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-booster vaccination, 28 days and 4 years post-booster vaccinationPopulation: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Outcome measures
| Measure |
All Subjects; Menactra Vaccine
n=109 Participants
Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
|
|---|---|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup W-135; 4 years post-booster (N=109)
|
95.4 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup A; Pre-booster (N=108)
|
67.6 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup A; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup A; 4 years post-booster (N=109)
|
94.5 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup C; Pre-booster (N=108)
|
53.7 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup C; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup C; 4 years post-booster (N=109)
|
81.7 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup Y; Pre-booster (N=108)
|
46.3 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup Y; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup Y; 4 years post-booster (N=109)
|
97.2 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup W-135; Pre-booster (N=108)
|
72.2 Percentage of participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup W-135; 28 days post-booster (N=109)
|
100.0 Percentage of participants
|
PRIMARY outcome
Timeframe: Pre-booster, 28 Days and 4 years post-booster vaccinationPopulation: Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Outcome measures
| Measure |
All Subjects; Menactra Vaccine
n=109 Participants
Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
|
|---|---|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup Y; Pre-booster (N=108)
|
7.50 Titers (1/dilution)
Interval 5.6 to 10.0
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup Y; 28 days post-booster (N=109)
|
1650 Titers (1/dilution)
Interval 1301.2 to 2091.8
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup Y; 4 years post-booster (N=109)
|
120 Titers (1/dilution)
Interval 88.9 to 162.3
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup W-135; Pre-booster (N=108)
|
13.4 Titers (1/dilution)
Interval 10.4 to 17.3
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup A; Pre-booster (N=108)
|
9.33 Titers (1/dilution)
Interval 7.7 to 11.3
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup A; 28 days post-booster (N=109)
|
460 Titers (1/dilution)
Interval 348.4 to 606.2
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup A; 4 years post-booster (N=109)
|
57.8 Titers (1/dilution)
Interval 44.2 to 75.6
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup C; Pre-booster (N=108)
|
11.2 Titers (1/dilution)
Interval 8.0 to 15.8
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup C; 28 days post-booster (N=109)
|
1224 Titers (1/dilution)
Interval 930.1 to 1609.6
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup C; 4 years post-booster (N=109)
|
54.6 Titers (1/dilution)
Interval 36.8 to 81.0
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup W-135; 28 days post-booster (N=109)
|
1170 Titers (1/dilution)
Interval 881.5 to 1553.8
|
|
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Serogroup W-135; 4 years post-booster (N=109)
|
93.1 Titers (1/dilution)
Interval 69.4 to 125.0
|
Adverse Events
All Subjects; Menactra Vaccine
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