Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
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To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.
Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR)
Study Start Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Months to 20 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female children between and including 18 -20 months of age at the time of the vaccination.
Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
Written informed consent obtained before study entry from the parents or guardians of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.