Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy Infants
Haemophilus Influenzae Type b, Diphtheria, Whole Cell Pertussis
About this trial
This is an interventional prevention trial for Haemophilus Influenzae Type b
Eligibility Criteria
Inclusion criteria: Healthy infants aged 3 days or less, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks. Result of the maternal blood sample (presence/not of hepatitis B virus) is available. Exclusion criteria: Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. A family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (except for immunoglobulins given at birth to infants born to HBsAg seropositive mothers). Acute disease at the time of enrolment. Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease. Hepatitis B vaccine given at birth outside the study.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site