Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This protocol posting describes the booster phase of the study. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00289731

Hepatitis B Hepatitis A

COMPLETED PHASE4

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

NCT00289744

Hepatitis B Hepatitis A

COMPLETED PHASE3

Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults

NCT00697853

Hepatitis B

COMPLETED PHASE2

Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

NCT00696891

Hepatitis B

COMPLETED PHASE3

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

NCT00289718

Hepatitis B Hepatitis A

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis B Hepatitis A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Twinrix

Intervention Type BIOLOGICAL

Engerix-B

Intervention Type BIOLOGICAL

Havrix

Intervention Type BIOLOGICAL

HBVAXPRO

Intervention Type BIOLOGICAL

Vaqta

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A male or female who completed the primary vaccination phase of the study.
* Written informed consent obtained from the subject.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Pregnant or lactating female.

Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Wilrijk, , Belgium

Site Status

GSK Investigational Site

Finsterwalde, Brandenburg, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Geringswalde, Saxony, Germany

Site Status

GSK Investigational Site

Pirna, Saxony, Germany

Site Status

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Bad Segeberg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Elmshorn, Schleswig-Holstein, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium Germany

References

Explore related publications, articles, or registry entries linked to this study.

Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. doi: 10.1111/j.1708-8305.2010.00499.x. Epub 2011 Feb 7.

Reference Type DERIVED

PMID: 21366801 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.