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

Phase 2

Completed

• Conditions: Diphtheria; Pertussis; Polio; Hepatitis B; Tetanus
• Interventions: Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC

• Registration Number: NCT00362427
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-09
• Study First Submitted QC: 2006-08-09
• Study First Posted: 2006-08-10
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC	-
Group B	Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC	-
Group C	Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC	-

Primary Outcome Measures

Name	Time	Method
To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar	14 Months