Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
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ClinicalTrials.gov Identifier: NCT00362427 |
Recruitment Status :
Completed
First Posted : August 10, 2006
Last Update Posted : January 14, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Pertussis Polio Hepatitis B Tetanus | Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 460 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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® |
Study Start Date : | August 2006 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A |
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 mL, 4 doses, IM
Other Name: PR5I |
Experimental: Group B |
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 Ml, 4 doses, IM
Other Name: PR5I |
Active Comparator: Group C |
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 mL, 4 doses, IM with concommitant vaccines
Other Names:
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- To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar [ Time Frame: 14 Months ]

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Ages Eligible for Study: | 42 Days to 89 Days (Child) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362427
Canada, British Columbia | |
Coquitlam, British Columbia, Canada, V3C 4J2 | |
Surrey, British Columbia, Canada, V3R 8P8 | |
Canada, Manitoba | |
Winnipeg, Manitoba, Canada, R3E 3P4 | |
Canada, Nova Scotia | |
Halifax, Nova Scotia, Canada, B3K 6R8 | |
Canada, Ontario | |
Ottawa, Ontario, Canada, K1S 0G8 | |
Canada, Quebec | |
Beauport, Quebec, Canada, G1E 7G9 | |
Montréal, Quebec, Canada, H3H 1P3 | |
Montréal, Quebec, Canada, H3T 1C5 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi Pasteur, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00362427 |
Other Study ID Numbers: |
PR504 |
First Posted: | August 10, 2006 Key Record Dates |
Last Update Posted: | January 14, 2014 |
Last Verified: | January 2014 |
Hepatitis B Pertussis Diphtheria |
Tetanus H. influenzae type b Polio |
Hepatitis A Hepatitis B Whooping Cough Tetanus Diphtheria Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections |