Immunogenicity and Safety of Pentaxim™ in an Indian Population

Brief Title

Immunogenicity and Safety of Pentaxim™ in an Indian Population

Official Title

Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India.

Brief Summary

      The present clinical study will assess the immunogenicity as the primary objective and the
      reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined
      vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of
      age followed by a booster dose during the second year of life.

      Safety:

      This study will describe the safety after each dose of the primary series of the study's
      combined vaccine (Pentaxim™).
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine

Condition

Diphtheria

Intervention

Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine

Study Arms / Comparison Groups

 1

Description:  

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

226

Start Date

February 2006

Completion Date

December 2008

Primary Completion Date

April 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Aged 42 to 56 days inclusive on the day of inclusion

          -  Born at full term pregnancy (> 37 weeks) with a birth weight ≥ 2.5 kg

          -  Informed consent form signed by the parent(s) or other legal representative

          -  Able to attend all scheduled visits and to comply with all trial procedures

        Exclusion Criteria:

          -  Participation in another clinical trial in the 4 weeks preceding the (first) trial
             vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term
             systemic corticosteroids therapy

          -  Systemic hypersensitivity to any of the vaccine components or history of a
             life-threatening reaction to the trial vaccine or a vaccine containing the same
             substances

          -  Chronic illness at a stage that could interfere with trial conduct or completion.

          -  Blood or blood-derived products received in the past.

          -  Any vaccination preceding the trial vaccination (except BCG and hepatitis B)

          -  History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus
             influenza type b (confirmed either clinically, serologically or microbiologically).

          -  Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis
             diseases or Haemophilus influenza type b infection with the trial vaccine or another
             vaccine.

          -  Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

          -  History of/current seizures

          -  Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or
             acute illness on the day of inclusion.
      

Gender

All

Ages

42 Days - 56 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

India

Location Countries

India

NCT ID

NCT00259337

Organization ID

E2I41

Responsible Party

Sponsor

Study Sponsor

Sanofi

Study Sponsor

Medical Director, Study Director, Sanofi Pasteur Inc.

Verification Date

April 2012