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Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

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ClinicalTrials.gov Identifier: NCT00343421
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE June 21, 2006
First Posted Date  ICMJE June 23, 2006
Last Update Posted Date June 3, 2016
Study Start Date  ICMJE July 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2008)
To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: 1 month post-vaccination ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2008)
To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: Entire study ]
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 to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
Official Title  ICMJE Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Infanrix®-IPV+Hib When Both Vaccines Are Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age
Brief Summary

The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.

Primary Objectives:

  • To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
  • To describe the post-dose 3 pertussis antibody responses.

Secondary Objectives:

  • To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
  • To describe the safety after each vaccination following co-administration with Prevenar®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
  • Haemophilus Influenzae Type b
Intervention  ICMJE
  • Biological: PEDIACEL® and Prevenar®
    0.5 mL each, IM (opposite thigh)
    Other Names:
    • PEDIACEL®: DT5aP-IPV-Hib 5-component Pertussis vaccine
    • Prevenar®: Pneumococcal saccharide conj. vaccine, adsorbed
  • Biological: Infanrix®-IPV+Hib and Prevenar®
    0.5 mL each, IM (opposite thigh)
    Other Names:
    • Infanrix®-IPV+Hib: DTap, IPV and adsorbed conjugated Hib
    • Prevenar®: Pneumococcal saccharide conj vaccine, adsorbed.
Study Arms  ICMJE
  • Experimental: Group 1
    PEDIACEL co-administered with Prevenar
    Intervention: Biological: PEDIACEL® and Prevenar®
  • Active Comparator: Group 2
    Infanrix-IPV+Hib co-administered with Prevenar
    Intervention: Biological: Infanrix®-IPV+Hib and Prevenar®
Publications * Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP₅-IPV-Hib compared with DTaP₃-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.

*   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: January 20, 2010)
588
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants 55 to 75 days old, inclusive on the day of first vaccination
  • Born at full term of pregnancy (> 37 weeks)
  • Informed consent form signed by the parent(s) or the legal guardian
  • Parents or the legal guardian able to read and write in the local language
  • Parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures.

Exclusion Criteria:

  • Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
  • Moderate or severe acute illness with or without fever
  • Participation in another clinical trial in the 30 days preceding first study vaccination
  • Planned participation in another clinical trial during the present study period
  • Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination
  • Received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations
  • Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days) in the previous 30 days
  • Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
  • History of life-threatening reaction(s) (such as encephalopathy, Hypotonic-Hyporesponsive Episode, rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines
  • Blood or blood-derived products (immunoglobulins) received since birth
  • Known Human immunodeficiency virus (HIV) seropositivity
  • Known thrombocytopenia or other bleeding disorder contraindicating intramuscular vaccination
  • History of encephalopathy, seizures or progressive, evolving or unstable neurological condition
  • Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Days to 75 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00343421
Other Study ID Numbers  ICMJE A5I16
Has Data Monitoring Committee No
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 Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date June 2016

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