Status:
COMPLETED
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
Lead Sponsor:
Sanofi
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
510-578 years
Phase:
PHASE3
Brief Summary
This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00303316
Start Date
February 1 2006
End Date
September 1 2007
Last Update
February 22 2013
Active Locations (1)
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1
Córdoba, Córdoba Province, Argentina, 5000