Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
Diphtheria, Tetanus, Poliomyelitis
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Diphteria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, acellular
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. 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.
Sites / Locations
Arms of the Study
Arm 1
Experimental
1