Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®

A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar®

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 infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.

Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®

Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.

Inclusion Criteria:

• 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 Criteria:

• 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.