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Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

NCT00289731 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2019-11-15

Study results available
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Summary

The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

TWINRIX™

Intramuscular injection, 3 doses

BIOLOGICAL

Engerix™-B

Intramuscular injection, 3 doses

BIOLOGICAL

HAVRIX™

Intramuscular injection, 2 doses

BIOLOGICAL

HB VAX PRO™

Intramuscular injection, 3 doses

BIOLOGICAL

Vaqta™

Intramuscular injection, 2 doses

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
41 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-11-24
Primary Completion
2004-12-21
Completion
2004-12-21

Countries

  • Belgium
  • Czechia
  • Germany

Study Locations

More Related Trials

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 NCT00289731 on ClinicalTrials.gov