Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00355654
First received: July 20, 2006
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®.

Primary Objective:

To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age.

Secondary Objectives:

  • To describe the incidence rate of severe fever within four days post-vaccination
  • To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.

Condition Intervention Phase
Infant
Healthy
Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
Biological: DT3aP-HBs-IPV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Booster Vaccination With PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination With Infanrix® Hexa When Both Vaccines Are Co-Administered With Prevenar® to Toddlers 11-18 Months of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the safety after administration of PEDIACEL® booster dose [ Time Frame: 0 to 3 Days post-vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To provide information concerning the safety (as fever rate) after administration of PEDIACEL® Vaccine [ Time Frame: 4 days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 847
Study Start Date: September 2006
Study Completion Date: July 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Participants will receive PEDIACEL with Prevenar at Visit 1 and ENGERIX-B Kinder at Visit 2
Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
0.5 mL, IM
Other Name: Pediacel™
Active Comparator: Group 2
Participants will receive Infanrix hexa with Prevenar at Visit 1
Biological: DT3aP-HBs-IPV
0.5 mL, IM
Other Name: Infanrix® hexa

  Eligibility

Ages Eligible for Study:   11 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Toddlers 11-18 months of age (from the 11th month birthday to one day prior to the 19th month birthday) who previously received the primary immunisation series with a hexavalent vaccine (consisting of three doses of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Haemophilus influenza type b combined vaccine administered within the first 6 months of life)
  • Informed consent form signed by both parents or by the legal guardian
  • Parents or a legal guardian able to read and write the local language
  • Parents or a 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 study vaccination
  • Planned participation in another clinical trial during the present study period
  • Immunisation with a pneumococcal vaccine prior to study vaccination or planned during the participation in the study
  • Received more than 3 doses of a hexavalent vaccine prior to study vaccination
  • Received any vaccination in the 30 days preceding the trial
  • History of serological/microbiologically-confirmed diagnosis of infection due to pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae
  • 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 30 days prior to study vaccination)
  • Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
  • History of a life-threatening reaction (such as encephalopathy, Hypotonic-Hyporesponsive Episode (HHE), 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 during 3 months prior to study vaccination
  • Known HIV seropositivity
  • Known thrombocytopenia or a 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: NCT00355654

  Show 84 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00355654     History of Changes
Other Study ID Numbers: A5I19
Study First Received: July 20, 2006
Last Updated: April 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Poliomyelitis
Haemophilus influenzae type b
Hepatitis B

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 20, 2014