Status:
COMPLETED
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Tetanus
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is as follows: * To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three for...
Detailed Description
This study will be conducted in two stages: At 10 months age, half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide (PS) vaccine at 10 months age. At 15 to 18 mon...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- • Healthy child 10 months that participated in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001), written informed consent obtained from the parents.
- Exclusion criteria:
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during study period.
- Chronic administration (\> 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal disease and/or Hib since the last visit of study 759346/001.
- History of/known exposure to diphtheria, tetanus, pertussis, hepatitis B, serogroups A or C meningococcal and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2004
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00317174
Start Date
July 1 2003
End Date
April 1 2004
Last Update
September 9 2016
Active Locations (1)
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1
GSK Investigational Site
City of Muntinlupa, Philippines, 1781