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.

Sanofi0 sites226 target enrollmentFebruary 2006

ConditionsDiphtheria Tetanus Polio Pertussis Haemophilus Infections

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diphtheria
Sponsor: Sanofi
Enrollment: 226
Primary Endpoint: To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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™).

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

December 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Responsible Party

Sponsor

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