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Trial record 1 of 1 for:    MTA00093
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Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier

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ClinicalTrials.gov Identifier: NCT02633787
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Meningitis
Meningococcal Meningitis
Meningococcal Infections
Intervention Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Enrollment 110
Recruitment Details Study participants were enrolled from 15 December 2015 to 28 December 2015 at 4 clinic sites in the United States.
Pre-assignment Details A total of 110 participants who met all inclusion and none of the exclusion criteria were enrolled; 109 participants completed the trial.
Arm/Group Title All Subjects; Menactra Vaccine
Hide Arm/Group Description Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
Period Title: Overall Study
Started 110
Completed 109
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title All Subjects; Menactra Vaccine
Hide Arm/Group Description Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
<=18 years
0
   0.0%
Between 18 and 65 years
110
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants
22.2  (3.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
61
  55.5%
Male
49
  44.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants
110
1.Primary Outcome
Title Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.
Hide Description Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Time Frame Pre-booster vaccination, 28 days, and 4 years post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title All Subjects; Menactra Vaccine
Hide Arm/Group Description:
Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
Overall Number of Participants Analyzed 109
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre-booster (N=108) 88.0
Serogroup A; 28 days post-booster (N=109) 100.0
Serogroup A; 4 years post-booster (N=109) 98.2
Serogroup C; Pre-booster (N=108) 67.6
Serogroup C; 28 days post-booster (N=109) 100.0
Serogroup C; 4 years post-booster (N=109) 89.9
Serogroup Y; Pre-booster (N=108) 57.4
Serogroup Y; 28 days post-booster (N=109) 100.0
Serogroup Y; 4 years post-booster (N=109) 98.2
Serogroup W-135; Pre-booster (N=108) 83.3
Serogroup W-135; 28 days post-booster (N=109) 100.0
Serogroup W-135; 4 years post-booster (N=109) 97.2
2.Primary Outcome
Title Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Hide Description Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Time Frame Pre-booster vaccination, 28 days and 4 years post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title All Subjects; Menactra Vaccine
Hide Arm/Group Description:
Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
Overall Number of Participants Analyzed 109
Measure Type: Number
Unit of Measure: Percentage of participants
Serogroup A; Pre-booster (N=108) 67.6
Serogroup A; 28 days post-booster (N=109) 100.0
Serogroup A; 4 years post-booster (N=109) 94.5
Serogroup C; Pre-booster (N=108) 53.7
Serogroup C; 28 days post-booster (N=109) 100.0
Serogroup C; 4 years post-booster (N=109) 81.7
Serogroup Y; Pre-booster (N=108) 46.3
Serogroup Y; 28 days post-booster (N=109) 100.0
Serogroup Y; 4 years post-booster (N=109) 97.2
Serogroup W-135; Pre-booster (N=108) 72.2
Serogroup W-135; 28 days post-booster (N=109) 100.0
Serogroup W-135; 4 years post-booster (N=109) 95.4
3.Primary Outcome
Title Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination
Hide Description Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Time Frame Pre-booster, 28 Days and 4 years post-booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.
Arm/Group Title All Subjects; Menactra Vaccine
Hide Arm/Group Description:
Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
Overall Number of Participants Analyzed 109
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilution)
Serogroup A; Pre-booster (N=108)
9.33
(7.7 to 11.3)
Serogroup A; 28 days post-booster (N=109)
460
(348.4 to 606.2)
Serogroup A; 4 years post-booster (N=109)
57.8
(44.2 to 75.6)
Serogroup C; Pre-booster (N=108)
11.2
(8.0 to 15.8)
Serogroup C; 28 days post-booster (N=109)
1224
(930.1 to 1609.6)
Serogroup C; 4 years post-booster (N=109)
54.6
(36.8 to 81.0)
Serogroup Y; Pre-booster (N=108)
7.50
(5.6 to 10.0)
Serogroup Y; 28 days post-booster (N=109)
1650
(1301.2 to 2091.8)
Serogroup Y; 4 years post-booster (N=109)
120
(88.9 to 162.3)
Serogroup W-135; Pre-booster (N=108)
13.4
(10.4 to 17.3)
Serogroup W-135; 28 days post-booster (N=109)
1170
(881.5 to 1553.8)
Serogroup W-135; 4 years post-booster (N=109)
93.1
(69.4 to 125.0)
Time Frame Monitoring of safety events was limited to serious adverse events considered related to study procedures (i.e., collection of the blood sample).
Adverse Event Reporting Description As no vaccine was administered in this trial, monitoring of safety events was limited to serious adverse events considered related to study procedures (i.e., collection of the blood sample). No safety events were reported. This was an immunogenicity assessment involving participants of an earlier study MTA77 (NCT01442675).
 
Arm/Group Title All Subjects; Menactra Vaccine
Hide Arm/Group Description Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
All-Cause Mortality
All Subjects; Menactra Vaccine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects; Menactra Vaccine
Affected / at Risk (%)
Total   0/110 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
All Subjects; Menactra Vaccine
Affected / at Risk (%)
Total   0/110 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02633787     History of Changes
Other Study ID Numbers: MTA00093
U1111-1161-3151 ( Other Identifier: WHO )
First Submitted: December 15, 2015
First Posted: December 17, 2015
Results First Submitted: August 1, 2016
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2016