Immunogenicity and Safety of Pentaxim™ in an Indian Population

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Haemophilus Infections

Polio

Pertussis

Tetanus

Treatments

Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00259337

E2I41

Details and patient eligibility

About

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™).

Enrollment

226 patients

Sex

All

Ages

42 to 56 days old

Volunteers

Accepts Healthy Volunteers

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.