Trials / Completed
CompletedNCT00289731
Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 596 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 41 Years
- Healthy volunteers
- Accepted
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.
Detailed description
The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2003-11-24
- Primary completion
- 2004-12-21
- Completion
- 2004-12-21
- First posted
- 2006-02-10
- Last updated
- 2019-11-15
- Results posted
- 2018-10-03
Locations
9 sites across 3 countries: Belgium, Czechia, Germany
Source: ClinicalTrials.gov record NCT00289731. Inclusion in this directory is not an endorsement.