Trials / Completed
CompletedNCT00317174
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 450 (planned)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 10 Months
- Healthy volunteers
- Accepted
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 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.
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 months age (DTP booster phase), all subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib2.5.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTPw-HBV/Hib-MenAC conjugate vaccine |
Timeline
- Start date
- 2003-07-01
- Completion
- 2004-04-01
- First posted
- 2006-04-24
- Last updated
- 2016-09-09
Locations
1 site across 1 country: Philippines
Source: ClinicalTrials.gov record NCT00317174. Inclusion in this directory is not an endorsement.