Status:
COMPLETED
Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcemia
Eligibility:
All Genders
13-21 years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00777790
Start Date
February 1 2004
End Date
April 1 2005
Last Update
February 14 2014
Active Locations (9)
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1
Atlanta, Georgia, United States, 30322
2
Marietta, Georgia, United States, 30062
3
Woburn, Massachusetts, United States, 01801
4
Albany, New York, United States, 12208