Status:
COMPLETED
Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcemia
Eligibility:
All Genders
3-5 years
Phase:
PHASE2
Brief Summary
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who w...
Detailed Description
This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, wh...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Stage I
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 3 years of age but not yet 6 years of age at the enrolment.
- For the TetraMenD group: received one dose of TetraMenD as a participant in trial 603-02 no less than 18 months prior to enrolment
- For the Control group: no previous history of any meningococcal vaccination
- Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
- Stage II
- Participant is healthy, as determined by medical history and physical examination.
- Participant is at least 3 years of age but not yet 6 years of age at the time of enrollment in Stage 1.
- Enrolled in the Control group only and received one dose of the reduced dose Menomune at Stage 1.
- Parent/Guardian has signed Institutional Review Board- (IRB-) approved informed consent form.
- 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 axillary temperature (≥ 99.5ºF \[≥ 37.5ºC\]) at the time of inclusion
- For Stage I, history of documented invasive meningococcal disease or previous meningococcal vaccination with exception of those participants recruited from Trial 603-02.
- For Stage II, history of documented invasive meningococcal disease or participant did not receive Reduced-dose Menomune® six months prior.
- 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 28-day period prior to study vaccination, or scheduled to receive any vaccination during the 28-day period after study vaccination in Stage 1 of the trial.
- 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
- 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 :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00772070
Start Date
March 1 2003
End Date
May 1 2004
Last Update
February 14 2014
Active Locations (8)
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1
Jonesboro, Arkansas, United States, 72401
2
Little Rock, Arkansas, United States, 72211
3
Woburn, Massachusetts, United States, 01801
4
Bridgeton, Missouri, United States, 63044