Status:
COMPLETED
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Diphtheria
Pertussis
Eligibility:
All Genders
42-89 years
Phase:
PHASE2
Brief Summary
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infect...
Eligibility Criteria
Inclusion
- Infants aged 42 to 89 days inclusive on the day of inclusion.
- Born at full term of pregnancy (\>37 weeks).
- Informed consent form signed by the parent(s) or legally authorized representative.
- Able to attend all scheduled visits and to comply with the study procedures.
- Parent or legally authorized representative has access to a telephone.
- Parent or legally authorized representative able to read and write in English or French.
Exclusion
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
- Chronic illness that could interfere with trial conduct or completion.
- Received blood or blood-derived products since birth.
- Any vaccination preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination (flu vaccine may be given a minimum of 4 weeks prior to the first study vaccination).
- Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, hepatitis B, or pneumococcal conjugate vaccines.
- Coagulation disorder contraindicating IM vaccination.
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Developmental delay or neurological disorder.
- Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- Documented Hepatitis B surface Antigen (HBsAg) seropositivity in the child or his/her mother.
- History of Hib, hepatitis B, diphtheria, tetanus, pertussis or poliovirus disease.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00362427
Start Date
August 1 2006
End Date
March 1 2009
Last Update
January 14 2014
Active Locations (8)
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1
Coquitlam, British Columbia, Canada, V3C 4J2
2
Surrey, British Columbia, Canada, V3R 8P8
3
Winnipeg, Manitoba, Canada, R3E 3P4
4
Halifax, Nova Scotia, Canada, B3K 6R8