The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Anti-PT, anti-FHA and anti-PRN antibody titers.
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers
Time frame: One month after the 3rd dose of the primary vaccination course
Occurrence of solicited adverse events
Time frame: During the 4-day follow-up period after each dose
Occurrence of unsolicited adverse events
Time frame: During the 30-day follow-up period after each dose
Occurrence of Serious Adverse Events
Time frame: Over the course of the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.