Long Term Follow-up Study at Yrs 2, 3, 4 & 5 Where 2 Dosing Sched.of the Combined Hepatitis A & B Vaccine Were Compared - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00197184

Purpose

To evaluate the persistence of anti-HAV and anti-HBs antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

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: Combined hepatitis A and B vaccine Biological: Combined hepatitis A and B vaccine, 3 doses, junior formulation in primary study	Phase III

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Hepatitis A Vaccines Twinrix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 m Schedule & a 0,1,6 m Schedule, in Healthy Children Aged Between 1-11 y at the Time of First Vaccine Dose

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-hepatitis A antibody concentrations [ Time Frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) ]
Anti-hepatitis B (HBs) antibody concentrations [ Time Frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) ]
Anti-HAV antibody concentrations [ Time Frame: Before and one month after additional vaccination ]
Anti-HBs antibody concentrations [ Time Frame: Before and One month after additional vaccination ]

Secondary Outcome Measures:

SAEs determined by the investigator to have a causal relationship to primary vaccination or due to lack of vaccine efficacy. [ Time Frame: during the long-term follow-up ]
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 relationship of unsolicited symptoms [ Time Frame: during the 30-day follow-up period after additional vaccination. ]
Recording of SAEs [ Time Frame: At least one month after additional vaccination ]

Enrollment:	276
Study Start Date:	November 2003
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: Combined hepatitis A and B vaccine IM injection in the left deltoid, 2 doses, Adult formulation in primary study
Group B: Active Comparator	Biological: Combined hepatitis A and B vaccine, 3 doses, junior formulation in primary study IM injection in the left deltoid

Detailed Description:

Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence; No additional subjects will be recruited during the long term follow-up period.

Eligibility

Ages Eligible for Study:	3 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Participation in primary study
Written informed consent obtained before each long term follow up visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197184

Locations

Australia, Victoria
GSK Clinical Trials Call Center
Carlton, Victoria, Australia, 3053
Belgium
GSK Clinical Trials Call Center
Brussels, Belgium
Spain
GSK Clinical Trials Call Center
Barcelona, Spain

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK Biologicals ( Isabelle Harpigny )
Study ID Numbers:	208127/132 (EXT Y2), 208127/133 (EXT Y3), 208127/134 (EXT Y4), 208127/137 (EXT Y5)
Study First Received:	September 15, 2005
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00197184
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

Combined hepatitis A and B vaccine
Twinrix™

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