Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
Infections, Meningococcal
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring meningococcal serogroups A and C diseases, tetanus, hepatitis B, pertussis, Haemophilus influenzae type b, meningococcal vaccine, Prophylaxis diphtheria
Eligibility Criteria
Inclusion Criteria: Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. A male or female between, and including, 15 and 18 months of age at the time of vaccination. Written informed consent obtained from the parent or guardian of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Having participated in the primary vaccination study (CPMS N° 759346/007). Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007). History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease. Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures including febrile seizures in infancy. Acute disease at the time of enrolment. Axillary temperature ≥ 37.5°C at the time of vaccination. Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period. Anaphylactic reaction following the administration of vaccine in the primary vaccination study. Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
AC primed Group
AC unprimed Group