Status:
COMPLETED
Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Neisseria Meningitidis
Meningococcal Infections
Eligibility:
All Genders
16-19 years
Phase:
PHASE3
Brief Summary
This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will ev...
Eligibility Criteria
Inclusion
- Healthy, as determined by medical history and physical examination.
- Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive).
- For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment.
- For the Control group, no previous history of any meningococcal vaccination.
- Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old
- Able to provide a vaccination log or has available vaccination record in the Health Center
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion
- 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 ≥ 37.5°C at the time of inclusion.
- Administration of immune globulin or 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 provided that they have not received more than one course within the last two weeks prior to enrollment.
- Oral or injected antibiotic therapy within the 72 hours prior to vaccination
- 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.
- Previous history of documented invasive meningococcal disease.
- Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine.
- Personal or family history of Guillain Barré syndrome.
- For female, known or suspected to be pregnant at the time of inclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00444951
Start Date
February 1 2007
End Date
February 1 2009
Last Update
July 14 2015
Active Locations (7)
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1
AlKhaleej, Al-Qassim Region, Saudi Arabia
2
AlRabwa, Al-Qassim Region, Saudi Arabia
3
S. Buraida, Al-Qassim Region, Saudi Arabia
4
Safra-Al Midhnab, Al-Qassim Region, Saudi Arabia