In this study, infants will be randomly allocated into three groups: * one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation) * the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation) * the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.
A study to compare the immunogenicity \& safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 \& 5 months age. The immunogenicity \& safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
415
GSK Investigational Site
Murmansk, Russia
GSK Investigational Site
Perm, Russia
GSK Investigational Site
Syktyvkar, Russia
GSK Investigational Site
Syktyvkar, Russia
One month after vaccination, measurement of antibodies against all vaccine antigens.
Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
Reactogenicity & safety: After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)."
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.