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

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Nov 24, 2005

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.