Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
Haemophilus Influenzae Type b, Diphtheria, Tetanus
About this trial
This is an interventional prevention trial for Haemophilus Influenzae Type b
Eligibility Criteria
Inclusion criteria Administration of one dose of hepatitis B vaccine at birth. A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination. 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 since birth. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required) Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life. Previous vaccination against diphtheria, tetanus, pertussis and/or Hib/History of diphteria, tetanus, pertussis, hepatitis B and/ or hib disease.
Sites / Locations
- GSK Investigational Site