Status:
COMPLETED
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcal Infection
Eligibility:
All Genders
7-15 years
Phase:
PHASE2
Brief Summary
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 additio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00258856
Start Date
January 1 2006
End Date
November 1 2007
Last Update
February 14 2014
Active Locations (11)
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1
Jonesboro, Arkansas, United States, 72401
2
Little Rock, Arkansas, United States, 72205
3
Marietta, Georgia, United States, 30062
4
Baltimore, Maryland, United States, 21201-1559