Status:
COMPLETED
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
50-70 years
Phase:
PHASE2
Brief Summary
Primary Objective: * To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP\~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Infant of either gender, aged 50 to 70 days inclusive
- Mother is negative for HBsAg
- Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
- Written informed consent form signed by at least one parent or by another legal representative and an independent witness
- Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.
- Exclusion Criteria :
- Axillary temperature ≥37.1°C on the day of inclusion
- Current or planned enrolment in another clinical trial during the clinical trial period
- Known mother's history of Human Immunodeficiency Virus (HIV) infection
- Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
- Receipt of blood-derived products since birth
- Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial
- Occurrence of seizures since birth
- Hypersensitivity to any of the vaccine components
- Coagulopathy contraindicating intramuscular injection
- History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
- History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
- Vaccination within the last 4 weeks.
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT00831311
Start Date
October 1 2004
End Date
March 1 2007
Last Update
December 17 2013
Active Locations (1)
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1
Córdoba, Argentina