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Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00287092
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.

Condition or disease Intervention/treatment Phase
Pertussis Diphtheria Tetanus Poliomyelitis Haemophilus Influenzae Type b Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine Biological: Infanrix® -IPV+Hib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 807 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomised, Controlled, Double-Blind Study of the 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 Given to Infants Using a Three Dose Immunisation Schedule ("Nordic Schedule" 3-5-12 Months)
Study Start Date : February 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : September 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Participants will receive PEDIACEL vaccine
 Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
0.5 mL, IM
Other Name: Pediacel™
Active Comparator: Group 2
Participants will receive Infanrix-IPV+Hib vaccines
 Biological: Infanrix® -IPV+Hib
0.5 mL, IM
Other Name: Infanrix®


Outcome Measures
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Primary Outcome Measures :
  1. To provide information concerning the immunogenicity of PEDIACEL® Vaccine. [ Time Frame: 1 Month post-dose 3 ]

Secondary Outcome Measures :
  1. To provide information concerning the safety after administration of PEDIACEL® Vaccine [ Time Frame: Entire study period ]

Eligibility Criteria
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Ages Eligible for Study:   80 Days to 120 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants aged 80 to 120 days inclusive on the day of inclusion.
  • Born at full term of pregnancy (> 37 weeks)
  • Informed consent form signed by the parent(s) or other legal representative according to local regulations
  • Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).

Exclusion Criteria:

  • Rectal temperature ≥ 38.0°C
  • Moderate or severe acute illness with or without fever
  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
  • Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
  • History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances
  • Blood or blood-derived products (immunoglobulins) received in the past 4 weeks
  • Vaccination planned in the 6 weeks following any trial vaccination
  • Known HIV seropositivity
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of seizures or progressive, evolving or unstable neurological condition
  • Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine 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): NCT00287092


Locations
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Finland
Espoo, Finland, 02100
Helsinki, Finland, 00100
Helsinki, Finland, 00930
Jarvenpaa, Finland, 04400
Jyvaskyla, Finland, 40100
Kotka, Finland, 48100
Lahti, Finland, 15140
Oulu, Finland, 90100
Pori, Finland, 28120
Tampere, Finland, 33520
Turku, Finland, 20520
Vantaa, Finland, 01300
Vantaa, Finland, 01600
Sweden
Ostersund, Sweden, S-831 83
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00287092    
Other Study ID Numbers: A5I15
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Haemophilus influenzae type b;
Corynebacterium diphtheriae;
Clostridium tetani;
Bordetella pertussis;
 poliovirus types 1, 2 and 3;
Vero cell;
Influenza;
Diphtheria
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