Diphtheria, Hepatitis B, Pertussis, Polio, Tetanus
Conditions
Keywords
Hepatitis B, Pertussis, Diphtheria, Tetanus, H. influenzae type b, Polio
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 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.
Interventions
BIOLOGICALHybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 mL, 4 doses, IM
Sponsors
Merck Sharp & Dohme LLC
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 89 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar | 14 Months |
Countries
Canada
Outcome results
None listed