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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 )

Study Description
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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®.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Pertussis Poliomyelitis Haemophilus Influenzae Type b Biological: PEDIACEL® and Prevenar® Biological: Infanrix®-IPV+Hib and Prevenar® Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 588 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : July 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2009

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: 1 month post-vaccination ]

Secondary Outcome Measures :
  1. To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: Entire study ]

Eligibility Criteria
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Ages Eligible for Study:   55 Days to 75 Days   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343421


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

Publications of Results:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00343421    
Other Study ID Numbers: A5I16
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Diphtheria
Tetanus
Pertussis
 Poliomyelitis
Haemophilus influenzae type b
Pneumococcal infections
Additional relevant MeSH terms:
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Whooping Cough
Tetanus
Diphtheria
Influenza, Human
Poliomyelitis
Tetany
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
 Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases