Status:
COMPLETED
Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcemia
Eligibility:
All Genders
3-6 years
Phase:
PHASE2
Brief Summary
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 Menactr...
Detailed Description
Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogen...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 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.
- Exclusion Criteria :
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00700713
Start Date
June 1 2008
End Date
March 1 2009
Last Update
February 15 2016
Active Locations (13)
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1
Marietta, Georgia, United States, 30062
2
Woodstock, Georgia, United States, 30189
3
Bardstown, Kentucky, United States, 40004
4
Annapolis, Maryland, United States, 21401