Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00787228

Purpose

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Prophylaxis Hepatitis B	Biological: placebo Biological: Engerix™-B (thiomersal-free) 20µg Biological: 10 μg Engerix™-B (preservative-free)	Phase III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Thimerosal Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Long-Term Study of Immune Response Persistence of GSK Biologicals' 2-Dose Thiomersal-Free Engerix™-B and 3-Dose Preservative-Free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations [ Time Frame: At Months 30, 42, 54 & 66 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of serious adverse events determined by the investigators to have a causal relationship to vaccination or to study procedures [ Time Frame: At Months 30, 42, 54 & 66 ] [ Designated as safety issue: Yes ]

Enrollment:	234
Study Start Date:	April 2004
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator	Biological: 10 μg Engerix™-B (preservative-free) In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)
Group A: Experimental	Biological: placebo In the primary study: 1 deep intramuscular injection (month 1) Biological: Engerix™-B (thiomersal-free) 20µg In the primary study: 2 deep intramuscular injections (Months 0, & 6)

Detailed Description:

All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Eligibility

Ages Eligible for Study:	13 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects have participated in primary study HBV-280
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

Exclusion Criteria: not applicable

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787228

Locations

Australia, New South Wales
GSK Investigational Site
Sydney, New South Wales, Australia
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Wilrijk, Belgium, 2610
Ukraine
GSK Investigational Site
Kyiv, Ukraine, 03038

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	101695, 101696, 101697, 101698
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787228 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by GlaxoSmithKline:

Persistence
hepatitis B vaccine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009