LT FU Studies at Y6, 7 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 y. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00197119

Purpose

To evaluate the persistence of anti-HAV and anti-HBs antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.

Condition	Intervention	Phase
Hepatitis A Hepatitis B	Biological: TwinrixTM Junior Biological: TwinrixTM Adult	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluate Persistence of Immune Response of GSK Biologicals' TWINRIX™ Vaccine Administered According to 0,6 Mth Schedule Versus TWINRIX™ JUNIOR Admd Accord. to 0,1,6 Mth Schedule, in Subjects Aged 12-15 y at Time of First Vaccine Dose.

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Twinrix

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Subjects With Anti-Hepatitis A (HAV) Antibody Concentrations Above the Cut-Off Value. [ Time Frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084. ] [ Designated as safety issue: No ]
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value [ Time Frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of the two-dose or three-dose primary vaccination in study HAB-084. ] [ Designated as safety issue: No ]
Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) [ Designated as safety issue: No ]

Enrollment:	244
Study Start Date:	May 2004
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group Tinwrix Adult: Active Comparator Subjects received TwinrixTM Adult (720/20) in a 0, 6 month schedule in the primary study	Biological: TwinrixTM Adult IM administration in the deltoid region (2 doses).
Group Twinrix Junior: Active Comparator Subjects received TwinrixTM Junior (360/10) in a 0, 1, 6 month schedule in the primary study	Biological: TwinrixTM Junior IM administration in the deltoid region (3 doses).

Detailed Description:

Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GSK Biologicals combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility

Ages Eligible for Study:	12 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male and female volunteers vaccinated in study HAB-084.
Written informed consent obtained from the subject before the blood sampling visit of each year

Exclusion Criteria: none

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197119

Locations

Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 03

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	100566, 100567, 100568, 100569, 100570
Study First Received:	September 14, 2005
Results First Received:	July 2, 2009
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00197119 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Keywords provided by GlaxoSmithKline:

Hepatitis A
Hepatitis B
TWINRIX™ Adult
TWINRIX™ Junior

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
Enterovirus Infections

Additional relevant MeSH terms:

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

Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections

ClinicalTrials.gov processed this record on September 03, 2009