Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier

Phase 4

Completed

• Conditions: Meningococcal Meningitis; Meningococcal Infections; Meningitis
• Interventions: Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

• Registration Number: NCT02633787
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).

Objective:

* To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77

Detailed Description

All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's participation in the trial will be the duration of 1 visit (for enrollment and blood draw)

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-17
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Results First Submitted: 2016-08-01
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-21
• Last Update Submitted: 2016-09-21
• Results First Posted: 2016-11-06
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Aged ≥ 18 years on the day of inclusion
• Received booster dose of Menactra vaccine in trial MTA77
• Informed consent form has been signed and dated
• Able to attend the scheduled visit and to comply with all trial procedures.

Exclusion Criteria

• Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
• Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction
• Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.)
• Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Participants received a booster dose of Menactra vaccine approximately four years earlier

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.	Pre-booster vaccination, 28 days, and 4 years post-booster vaccination	Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination	Pre-booster vaccination, 28 days and 4 years post-booster vaccination	Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.
Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination	Pre-booster, 28 Days and 4 years post-booster vaccination	Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.