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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE August 9, 2006
First Posted Date  ICMJE August 10, 2006
Last Update Posted Date January 14, 2014
Study Start Date  ICMJE August 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar [ Time Frame: 14 Months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
Official Title  ICMJE 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®
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Pertussis
  • Polio
  • Hepatitis B
  • Tetanus
Intervention  ICMJE
  • Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
    0.5 mL, 4 doses, IM
    Other Name: PR5I
  • Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
    0.5 Ml, 4 doses, IM
    Other Name: 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®
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
  • Experimental: Group B
    Intervention: Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
  • Active Comparator: Group C
    Intervention: Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2010)
460
Original Enrollment  ICMJE
 (submitted: August 9, 2006)
477
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 89 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00362427
Other Study ID Numbers  ICMJE PR504
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP