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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00787449

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: Twinrix Hepatitis A Vaccines

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 B (HBs) antibody concentrations [ Time Frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) ] [ Designated as safety issue: No ]
Anti-HAV antibody concentrations [ Time Frame: Before and one month after additional vaccination ] [ Designated as safety issue: No ]
Anti-HBs antibody concentrations [ Time Frame: Before and One month after additional vaccination ] [ Designated as safety issue: No ]
Anti-hepatitis A antibody concentrations [ Time Frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
Occurrence and intensity of solicited local symptoms [ Time Frame: during the 4-day follow-up period after additional vaccination ] [ Designated as safety issue: Yes ]
Occurrence, intensity and causal relationship of solicited general symptoms [ Time Frame: During the 4-day follow-up period after additional vaccination ] [ Designated as safety issue: Yes ]
Occurrence, intensity and relationship of unsolicited symptoms [ Time Frame: during the 30-day follow-up period after additional vaccination. ] [ Designated as safety issue: Yes ]
Recording of SAEs [ Time Frame: AT least one month after additional vaccination ] [ Designated as safety issue: Yes ]

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

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

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.

Exclusion Criteria: not applicable

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787449

Locations

Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
Spain
GSK Investigational Site
Barcelona, Spain, 08042

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	208127/132, 208127/133, 208127/134, 208127/137
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787449 History of Changes
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:

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 May 07, 2009