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A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.

NCT00317174 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2016-09-09

No results posted yet for this study

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.

Conditions

  • Haemophilus Influenzae Type b
  • Tetanus
  • Whole Cell Pertussis
  • Hepatitis B
  • Diphtheria

Interventions

BIOLOGICAL

DTPw-HBV/Hib-MenAC conjugate vaccine

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Completion
2004-04-30

Countries

  • Philippines

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00317174 on ClinicalTrials.gov