Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

Completed · Phase 2

Conditions studied: Meningitis, Meningococcal Infection

In brief

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.

Key facts

Study ID

NCT00258856

Run by

Sanofi Pasteur, a Sanofi Company

People needed

234

Starts

2006-01-01

Expected to finish

2007-11-01

Last updated by the study team

2014-02-14

Who can join

Age: 7 and older, up to 15. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is healthy, as determined by medical history.
• Subject is between the ages of 7 and 15 years (not yet 16 years).
• For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
• The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
• A negative urine pregnancy test is required for menstruating female subjects.
• Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.

You may not qualify if…

• Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
• History of documented invasive meningococcal disease
• Received any other meningococcal vaccine
• Received any vaccine in the 28-day period prior to enrollment
• Received antibiotic therapy within the 72 hours prior to collection of a blood sample
• Actively enrolled or scheduled to be enrolled in another clinical study
• Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system)
• Known or suspected impairment of immunologic function
• Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
• Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment
• Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
• Personal of family history of Guillain-Barres Syndrome
• Suspected or known hypersensitivity to any of the vaccine components
• Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
• Any condition which, in the opinion of the investigator, would pose a health risk to the participant.

Where it is running

• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Marietta, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Bridgeton, Missouri, United States
• Study site — Rochester, New York, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Sellersville, Pennsylvania, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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