Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected Acc to a 0,1,6 Mth Schedule - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00289718

Purpose

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 to 15.

Condition	Intervention	Phase
Hepatitis A Hepatitis B	Biological: Twinrix™ adult	Phase III

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Hepatitis B Vaccines Hepatitis A Vaccines Twinrix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-hepatitis A (HAV) antibody concentrations [ Time Frame: Years 11, 12, 13, 14 and 15 ]
Anti-hepatitis B (HBs) antibody concentrations [ Time Frame: Years 11, 12, 13, 14 and 15 ]

Secondary Outcome Measures:

Anti-HAV antibody concentrations [ Time Frame: before and one month after the additional dose ]
Anti-HBs antibody concentrations [ Time Frame: before and one month after the additional dose ]
Serious adverse events (SAEs) that are determined by the investigator to have a causal relationship to primary vaccination or are due to lack of vaccine efficacy [ Time Frame: during the follow up period ]
Occurrence and intensity of solicited local symptoms [ Time Frame: during the 4-day follow-up period after additional vaccination ]
Occurrence, intensity and causal relationship of solicited general symptoms [ Time Frame: during the 4-day follow-up period after additional vaccination ]
Occurrence, intensity and causal relationship of unsolicited symptoms [ Time Frame: during the 30-day follow-up period after additional vaccination ]
SAEs [ Time Frame: during the follow-up period after additional vaccination (minimum 30 days) ]

Enrollment:	56
Study Start Date:	November 2004
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Group received Lot A in primary study	Biological: Twinrix™ adult Intramuscular injection, 3 doses
Group B: Experimental Group received Lot B in primary study	Biological: Twinrix™ adult Intramuscular injection, 3 doses
Group C: Experimental Group received Lot C in primary study	Biological: Twinrix™ adult Intramuscular injection, 3 doses

Detailed Description:

This is a long-term follow-up study at Years 11, 12, 13, 14 and 15 after primary vaccination with GSK Biologicals' hepatitis A/hepatitis B vaccine (three-dose schedule, 3 different lots). To evaluate the long-term antibody persistence, volunteers will be bled at Years 11, 12, 13, 14 and 15 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

No additional subjects will be recruited during the course of this long-term study.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 11, 12, 13, 14 or 15), he/ she will be offered an additional vaccine dose.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.
Written informed consent will be obtained from each subject before the blood sampling visit of each year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289718

Locations

Belgium

Ghent, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	100556 (Y11), 100557 (Y12), 100558 (Y13), 100559 (Y14), 100560 (Y15)
Study First Received:	February 9, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00289718
Health Authority:	Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Hepatitis A
Hepatitis B
Combined Hepatitis A and B vaccine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis B
Picornaviridae Infections

Hepatitis, Viral, Human
Hepatitis A
DNA Virus Infections
Healthy
Enterovirus Infections

Additional relevant MeSH terms:

RNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 16, 2009