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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.
First Received: June 21, 2006   Last Updated: April 7, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00343421
  Purpose

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®.

Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Haemophilus Influenzae Type B
Biological: PEDIACEL® and Prevenar®
Biological: Infanrix®-IPV+Hib and Prevenar®
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 560
Study Start Date: July 2006
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Biological: PEDIACEL® and Prevenar®
0.5 mL each, IM (opposite thigh)
2: Active Comparator Biological: Infanrix®-IPV+Hib and Prevenar®
0.5 mL each, IM (opposite thigh)

  Eligibility

Ages Eligible for Study:   55 Days to 75 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00343421

Locations
France
Paris, France
Poland
Poznan, Poland
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur, Inc. ( Medical Monitor )
Study ID Numbers: A5I16
Study First Received: June 21, 2006
Last Updated: April 7, 2008
ClinicalTrials.gov Identifier: NCT00343421     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency;   Poland: Ministry of Health

Keywords provided by Sanofi-Aventis:
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Haemophilus influenzae type b
Pneumococcal infections

Study placed in the following topic categories:
Bacterial Infections
Spinal Cord Diseases
Whooping Cough
Orthomyxoviridae Infections
Tetanus
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Neuromuscular Diseases
Motor Neuron Disease
Degenerative Motor System Disease
Haemophilus Influenzae
Cough
Picornaviridae Infections
Central Nervous System Diseases
Diphtheria
Pneumococcal Infections
Virus Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human
Myelitis
Enterovirus Infections
Clostridium Infections

Additional relevant MeSH terms:
Bacterial Infections
Spinal Cord Diseases
Whooping Cough
Central Nervous System Viral Diseases
Orthomyxoviridae Infections
Infection
Tetanus
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Corynebacterium Infections
Motor Neuron Disease
RNA Virus Infections
Nervous System Diseases
Picornaviridae Infections
Central Nervous System Diseases
Diphtheria
Actinomycetales Infections
Bordetella Infections
Virus Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human
Myelitis
Enterovirus Infections
Clostridium Infections

ClinicalTrials.gov processed this record on July 02, 2009