Status:
COMPLETED
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
15-24 years
Phase:
PHASE3
Brief Summary
This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose...
Detailed Description
Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC. Blood samples will be...
Eligibility Criteria
Inclusion
- 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 24 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 DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329.
- 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; with the exception of oral poliovirus vaccine (OPV).
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478).
- History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C 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 vaccine.
- 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.
- Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2007
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT00291343
Start Date
February 1 2006
End Date
March 15 2007
Last Update
June 6 2018
Active Locations (2)
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1
GSK Investigational Site
Manila, Philippines, 1000
2
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008