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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Meningitis

Meningococcal Meningitis

Meningococcal Infections

Treatments

Biological: Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02633787

MTA00093

U1111-1161-3151 (Other Identifier)

Details and patient eligibility

About

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

Full 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)

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.