Status:
COMPLETED
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
6-10 years
Phase:
PHASE2
Brief Summary
To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™ vaccine and Tritan...
Detailed Description
Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 diffe...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
- Exclusion criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV).
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Hepatitis B and Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis B vaccine.
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT00291967
Start Date
November 1 2002
Last Update
December 8 2006
Active Locations (1)
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1
Manila, Philippines