Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine
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To assess safety and reactogenicity of GSK Biologicals' Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants (3, 4 and 5 months of age)
Condition or disease
Haemophilus Influenzae Type b Disease
Biological: Haemophilus Influenza type b vaccine
All subjects will be randomized into two groups. One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone. A specific follow-up of solicited local and general symptoms after each vaccination. A specific follow-up of unsolicited symptoms after each vaccination. Recording of serious adverse events reported during the study period.
Assess the Safety & Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone, in Healthy Infants at 3,4 & 5 Mths of Age
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
3 Months to 4 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
A male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
Planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose.
Chronic administration of immunosuppressants or other immune-modifying drugs from birth until administration of first dose of study vaccine.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use during the study period.