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

January 10, 2014 updated by: Sanofi Pasteur, a Sanofi Company

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®

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3C 4J2
      • Surrey, British Columbia, Canada, V3R 8P8
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
    • Ontario
      • Ottawa, Ontario, Canada, K1S 0G8
    • Quebec
      • Beauport, Quebec, Canada, G1E 7G9
      • Montréal, Quebec, Canada, H3H 1P3
      • Montréal, Quebec, Canada, H3T 1C5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • PR5I
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 Ml, 4 doses, IM
Other Names:
  • PR5I
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®
Experimental: Group B
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 mL, 4 doses, IM
Other Names:
  • PR5I
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 Ml, 4 doses, IM
Other Names:
  • PR5I
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®
Active Comparator: Group C
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 mL, 4 doses, IM
Other Names:
  • PR5I
Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
0.5 Ml, 4 doses, IM
Other Names:
  • PR5I
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®

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Collaborators

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 9, 2006

First Submitted That Met QC Criteria

August 9, 2006

First Posted (Estimate)

August 10, 2006

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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