Trial record 15 of 163 for:    "Haemophilus influenzae"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00287092
First received: February 3, 2006
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Pertussis
Diphtheria
Tetanus
Poliomyelitis
Haemophilus Influenzae Type b
Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine
Biological: Infanrix® -IPV+Hib
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: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of PEDIACEL® Vaccine. [ Time Frame: 1 Month post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety after administration of PEDIACEL® Vaccine [ Time Frame: Entire study period ] [ Designated as safety issue: Yes ]

Enrollment: 807
Study Start Date: February 2006
Study Completion Date: August 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   80 Days to 120 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287092

Locations
Finland
Espoo, Finland, 02100
Helsinki, Finland, 00930
Helsinki, Finland, 00100
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
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: NCT00287092     History of Changes
Other Study ID Numbers: A5I15
Study First Received: February 3, 2006
Last Updated: April 13, 2012
Health Authority: Finland: Finnish Medicines Agency
Sweden: Swedish National Council on Medical Ethics

Keywords provided by Sanofi:
Haemophilus influenzae type b;
Corynebacterium diphtheriae;
Clostridium tetani;
Bordetella pertussis;
poliovirus types 1, 2 and 3;
Vero cell;
Influenza;
Diphtheria

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 April 17, 2014