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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Diphtheria

Haemophilus Infections

Pertussis

Tetanus

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00255021

E2I34

Details and patient eligibility

About

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.

Enrollment

186 patients

Sex

All

Ages

2 to 2 months old

Volunteers

Accepts Healthy Volunteers

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.
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.