Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or Havrix+Typherix or Tiphim Vi, to Compare Reactogenicity & Immunogenicity

NCT00197249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1034

Last updated 2016-09-09

No results posted yet for this study

Summary

To evaluate the immunogenicity, reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix, and when compared to the administration of monovalent vaccines, Havrix or Typhim Vi. Furthermore, the study will evaluate the persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the first dose of the study vaccine.

Conditions

  • Hepatitis A

Interventions

BIOLOGICAL

Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2003-06-30
Completion
2005-11-30

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Entities

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 NCT00197249 on ClinicalTrials.gov