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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00289744

Purpose

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.

This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti- HAV and anti-HBs antibody concentrations [ Time Frame: Years 6, 7, 8, 9, and 10. ]

Secondary Outcome Measures:

Anti-HAV and anti-HBs antibody concentrations [ Time Frame: before and one month after the additional dose (if applicable) ]
Serious adverse events (SAEs) that are determined by the investigator to have a causal relationship to primary vaccination and lack of efficacy [ Time Frame: during the long-term follow-up ]
Occurrence 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:	178
Study Start Date:	February 2004
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: TWINRIX™ ADULT 2 doses IM injection in primary study

Detailed Description:

To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations 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 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289744

Locations

Belgium

Antwerp, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	100561 (Y6), 100562 (Year 7), 100563 (Year 8), 100564 (Year 9), 100565 (Year 10)
Study First Received:	February 9, 2006
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00289744
Health Authority:	Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Hepatitis A
Hepatitis B
TWINRIX™ ADULT

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