Brief Title
Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants
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)
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
Secondary Outcome
To provide information concerning the safety after administration of PEDIACEL® Vaccine
Condition
Pertussis
Intervention
DT5aP-IPV-Hib 5-component Pertussis vaccine
Study Arms / Comparison Groups
Group 1
Description: Participants will receive PEDIACEL vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
807
Start Date
February 2006
Completion Date
September 2008
Primary Completion Date
May 2007
Eligibility 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.
Gender
All
Ages
80 Days - 120 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT00287092
Organization ID
A5I15
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
January 2015