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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
720
GSK Investigational Site
Carlton, Victoria, Australia
Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Occurrence of local injection site reactions (1M after vacc).
Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
SAEs (full study).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.