Status:
COMPLETED
Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Polio
Eligibility:
All Genders
15-18 years
Phase:
PHASE3
Brief Summary
This is a follow-up of Study A3L10 (NCT00315055) Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP\~T or PENTAXIM™ and ENGERIX B®...
Eligibility Criteria
Inclusion
- Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP\~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.
- Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).
- Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- Participation in another clinical trial in the 4 weeks preceding the booster 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 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 3 months.
- Any vaccination in the 4 weeks preceding the booster vaccination.
- Any vaccination planned until second Visit.
- History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
- Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
- Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055).
- Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
- Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature \> 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for \> 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00619502
Start Date
December 1 2007
End Date
July 1 2008
Last Update
May 13 2016
Active Locations (1)
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1
Ankara, Turkey (Türkiye)