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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00343421
First received: June 21, 2006
Last updated: April 13, 2012
Last verified: April 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Enrollment: 588
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
PEDIACEL co-administered with Prevenar
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
Active Comparator: Group 2
Infanrix-IPV+Hib co-administered with Prevenar
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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Paris, France
Poland
Poznan, Poland
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00343421     History of Changes
Other Study ID Numbers: A5I16
Study First Received: June 21, 2006
Last Updated: April 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Poland: Ministry of Health

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

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

ClinicalTrials.gov processed this record on August 20, 2014