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Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
This study is ongoing, but not recruiting participants.
Study NCT00343421   Information provided by Sanofi-Aventis
First Received: June 21, 2006   Last Updated: April 7, 2008   History of Changes

June 21, 2006
April 7, 2008
July 2006
February 2009   (final data collection date for primary outcome measure)
To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00343421 on ClinicalTrials.gov Archive Site
To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]
Same as current
 
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
 

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®.
 
Phase III
Interventional
Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
  • Haemophilus Influenzae Type B
  • Biological: PEDIACEL® and Prevenar®
  • Biological: Infanrix®-IPV+Hib and Prevenar®
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
560
July 2009
February 2009   (final data collection date for primary outcome measure)

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 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.
Both
55 Days to 75 Days
Yes
Contact information is only displayed when the study is recruiting subjects
France,   Poland
 
NCT00343421
Medical Monitor, Sanofi Pasteur, Inc.
A5I16
Sanofi-Aventis
 
Study Director: Clinical Trials sanofi pasteur
Sanofi-Aventis
April 2008

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