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

Launched by SANOFI · Mar 13, 2006

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)
• • Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age
• • Written informed consent form signed by at least one parent or by a legal representative and an independent witness
• • Able to attend all scheduled visits and to comply with all trial procedures.
• 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.