Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants

Exclusion Criteria

• •Participation in another clinical trial in the four weeks preceding the trial vaccination
• •Planned participation in another clinical trial during the present trial period
• •Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroids therapy
• •Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to 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 last six months
• •Any vaccination in the four weeks preceding the trial
• •Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series
• •History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically)
• •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
• •History of seizures
• •Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion
• •Known contraindication to further vaccination with a pertussis vaccine such as:
• •Encephalopathy; Inconsolable crying for \>3 hours within 48 hours following vaccine injection
• •Hypotonic hyporesponsive episode within 48 hours following vaccine injection
• •Seizures with or without fever within three days following vaccine injection
• •Axillary temperature \>39.4°C or equivalent rectal temperature \> 40.0°C within 48 hours following vaccine injection.