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

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 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

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