Hepatitis B Clinical Trial
Official title:
Study to Assess Immunogenicity and Safety of GlaxoSmithKline Biologicals' Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs Concomitant Administration of CSL's Triple Antigen and GlaxoSmithKline Biologicals' Hiberix, to Infants at 2, 4, 6 Months of Age, After a Birth Dose of Hepatitis B
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.
"The study will be carried out in a partially double blind manner (i.e. double blind with
respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's
Triple Antigen & Hib group). Subjects will be randomly allocated to one of the three
following groups to receive:
- GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.
- GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.
- CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific
follow-up of solicited local and general symptoms during 4 days after each vaccination
and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events
reported during the study period will be recorded.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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