Status:
COMPLETED
Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcemia
Eligibility:
All Genders
2-4 years
Phase:
PHASE2
Brief Summary
The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent mening...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Participant is healthy, as determined by medical history and physical examination.
- Participant is 2 years to \< 5 years of age at the time of vaccination.
- At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
- Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.
- Exclusion Criteria :
- Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
- Known or suspected impairment of immunologic function
- Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5ºC at the time of inclusion
- History of documented invasive meningococcal disease
- 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 enrolment
- Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
- Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
- Received a meningococcal C conjugate vaccine within one year prior to enrolment
- 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 :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00771849
Start Date
August 1 2003
End Date
May 1 2004
Last Update
April 14 2016
Active Locations (2)
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1
London, United Kingdom, E1 1BB
2
London, United Kingdom, SW17 ORE