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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00362427
First received: August 9, 2006
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Diphtheria
Pertussis
Polio
Hepatitis B
Tetanus
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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®

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar [ Time Frame: 14 Months ] [ Designated as safety issue: No ]

Enrollment: 460
Study Start Date: August 2006
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • PR5I
  • PENTACEL™
  • NGERIX-B®

  Eligibility

Ages Eligible for Study:   42 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362427

Locations
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
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00362427     History of Changes
Other Study ID Numbers: PR504
Study First Received: August 9, 2006
Last Updated: January 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by Sanofi:
Hepatitis B
Pertussis
Diphtheria
Tetanus
H. influenzae type b
Polio

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014