Status:
COMPLETED
Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
15-18 years
Phase:
PHASE3
Brief Summary
This is a follow-up of Study A3L11 (NCT00404651). Immunogenicity * To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP\~T or Infanrix hexa™. * To...
Eligibility Criteria
Inclusion
- Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
- Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
- Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
- 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 the next visit.
- History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically).
- Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
- Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
- Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
- Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
- History of seizures.
- 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 :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
881 Patients enrolled
Trial Details
Trial ID
NCT00654901
Start Date
March 1 2008
End Date
July 1 2009
Last Update
May 13 2016
Active Locations (4)
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1
Estado de México, Mexico
2
Insurgentes Cuicuilco, Mexico
3
Monterrey, Mexico
4
Puebla City, Mexico