Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
Completed · Phase 2
Conditions studied: Meningitis, Meningococcemia
In brief
Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants. Objectives: * To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26. * To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects. * To describe the safety profile of a single dose of Menactra® vaccine in subjects.
Key facts
- Study ID
- NCT00700713
- Run by
- Sanofi Pasteur, a Sanofi Company
- People needed
- 181
- Starts
- 2008-06-01
- Expected to finish
- 2009-03-01
- Last updated by the study team
- 2016-02-15
Who can join
Age: 3 and older, up to 6. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received
- At 3 to < 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine).
- Informed consent form signed and dated by the parent(s) or another legally acceptable representative.
- Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures.
You may not qualify if…
- Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first study vaccination
- Planned participation in another clinical trial during the present trial period.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or to a product containing any of the substances present in the study vaccine.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- Received blood or blood-derived products in the past 3 months.
- Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first study vaccination.
- Planned receipt of any vaccine within the 4 weeks following the study vaccination.
- Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.
- History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).
- Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.
- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.
- Personal or family history of Guillain-Barré Syndrome (GBS).
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Where it is running
- Study site — Marietta, Georgia, United States
- Study site — Woodstock, Georgia, United States
- Study site — Bardstown, Kentucky, United States
- Study site — Annapolis, Maryland, United States
- Study site — Frederick, Maryland, United States
- Study site — Woburn, Massachusetts, United States
- Study site — Greenville, Pennsylvania, United States
- Study site — Harleysville, Pennsylvania, United States
- Study site — Pittsburgh, Pennsylvania, United States
- Study site — Pittsburgh, Pennsylvania, United States
- Study site — Kingsport, Tennessee, United States
- Study site — Layton, Utah, United States
- Study site — Provo, Utah, United States
Full record on ClinicalTrials.gov
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