Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand

Sanofi0 sites186 target enrollmentDecember 2005

ConditionsDiphtheria Tetanus Poliomyelitis Haemophilus Infections Pertussis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Diphtheria
Sponsor: Sanofi
Enrollment: 186
Primary Endpoint: Immunogenicity: To provide information concerning the immune response of the 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 and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

January 2009

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 53 to 70 days inclusive on the day of inclusion

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 corticosteroid 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.
•Mother known as seropositive to HIV or hepatitis B
•Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin \[BCG\])
•History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
•Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.