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

Study Overview
=================
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.

Official Title
-----------------
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®

Conditions
-----------------
Diphtheria, Pertussis, Polio, Hepatitis B, Tetanus

Intervention / Treatment
-----------------
* Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
* Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
* Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 42 Days
Maximum Age: 89 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC<br>* 0.5 mL, 4 doses, IM<br>* Other names: PR5I;|
| Experimental: Group B<br> | Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC<br>* 0.5 Ml, 4 doses, IM<br>* Other names: PR5I;|
| Active Comparator: Group C<br> | Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC<br>* 0.5 mL, 4 doses, IM with concommitant vaccines<br>* Other names: NGERIX-B®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar |  | 14 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, Pertussis, Diphtheria, Tetanus, H. influenzae type b, Polio