Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Oct 21, 2008

Keywords

ClinConnect Summary

All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • Participant is healthy, as determined by medical history and physical examination.
• • Participant is at least 13 years of age but not yet 22 years of age at time of enrollment.
• • For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up).
• • For the Control group, participant has no previous history of any meningococcal vaccination.
• • If \< 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form.
• • If ≥ 18 years of age, participant has signed an IRB-approved informed consent form.
• • Able to provide vaccination log.
• Exclusion Criteria :
• • Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc).
• • Known or suspected impairment of immunologic function.
• • Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of inclusion.
• • For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial.
• • For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination.
• • Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks 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.
• • Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn.
• • Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
• • 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.
• • In females, a positive or equivocal urine pregnancy test at the time of vaccination.
• • Enrolled in another clinical trial.
• • Any condition, which, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the vaccine.