Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Acellular Pertussis
Conditions
Brief summary
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.
Detailed description
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)
Interventions
BIOLOGICALDTPa-HBV-IPV/Hib vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
11 Weeks to 17 Weeks
Healthy volunteers
Yes
Inclusion criteria
* A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination. * Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available). * Born after a normal gestation period (between 36 and 42 weeks). * Written informed consent obtained from the parent or guardian of the subject.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Any chronic drug therapy to be continued during the study period. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose. * Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases. * Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One month after vaccination, measurement of antibodies against all vaccine antigens. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Russia
Outcome results
None listed