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

Completed · Phase 4

Conditions studied: Meningitis, Meningococcal Meningitis, Meningococcal Infections

In brief

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

Key facts

Study ID

NCT02633787

Run by

Sanofi Pasteur, a Sanofi Company

People needed

110

Starts

2015-12-01

Expected to finish

2016-03-01

Last updated by the study team

2016-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Bardstown, Kentucky, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Niles, Michigan, United States
• Study site — Layton, Utah, United States

Full record on ClinicalTrials.gov

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