A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
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 formulations) in the study DTPwHB/HibMenACTT001 (CPMS No. 759346/001) by giving unconjugated PRP, PSA and PSC at 10 months age to one subset of subjects.
- To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix™-HepB/Hib2.5 vaccine or Tritanrix™-HepB/Hib-MenAC vaccine at 15-18 months age in the other subset of subjects.
Neisseria Meningitidis Serogroup Diseases
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Assess Immune Persistence & Memory by Giving Plain PRP,PSA & PSC (10 Mths Age), & Immunogenicity & Safety of a Tritanrix™-HBV/Hib-MenAC/ Tritanrix™-HBV/Hib2.5 Booster (15-18 Mths Age) in Previously Primed Subjects|
- Pre & 1M post-plain PS, antibody levels & bactericidal titers (meningococcal serogroups A & C). Pre & 1M post-DTP booster, antibody levels for all vaccine antigens.
- Pre & 1M post-DTP booster (subset of subjects), antibody levels for all vaccine antigens. Retrospective serious adverse events (SAEs). Solicited (day 0-7), unsolicited events (day 0-30). SAEs (entire study)
|Study Start Date:||July 2003|
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 months age (DTP booster phase), all subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib2.5.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317174
|GSK Investigational Site|
|Muntinlupa, Philippines, 1781|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|