Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
Diphtheria, Acellular Pertussis, Tetanus
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, Prophylaxis, Haemophilus influenza type b diseases
Eligibility Criteria
Inclusion Criteria: A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject. Born after a normal gestation period (between 36 and 42 weeks). Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate. Exclusion Criteria: Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements). Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases. Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site