Immunogenicity and Safety of Pentaxim in South African Infants

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Diphtheria

Haemophilus Infections

Pertussis

Tetanus

Treatments

Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00254969

E2I43

Details and patient eligibility

About

The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.

Enrollment

212 patients

Sex

All

Ages

24+ hours old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged < 24 hours on the day of inclusion

Exclusion criteria

At visit 01 (screening)
Illness at a stage that could interfere with trial conduct or completion.
Any vaccination preceding the trial participation (except Bacille Calmette-Guerin [BCG])
Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
Planned participation in another clinical trial during the present trial period
Blood or blood-derived products received since birth.
Mother known as seropositive to HIV or hepatitis B.
Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of/current seizures at visit 02 (first study vaccination)
Participation in another clinical trial preceding the first trial vaccination
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.
Any vaccination preceding the first trial vaccination (except BCG)
History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination