Long-Term Immune Persistence of GSK Biologicals' Inactivated Hepatitis A Vaccine Injected Acc to a 0,12 Mth Schedule - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00291876

Purpose

The aim of this study is to evaluate the persistence of hepatitis A antibodies at 138, 150, 162, 174 and 186 months after subjects received their first dose of a 2 dose vaccination schedule of hepatitis A vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This protocol posting deals with objectives & outcome measures of the extension phase at year 11 through to 15.

No additional subjects will be recruited during this long-term follow-up.

Condition	Intervention	Phase
Hepatitis A	Biological: Havrix™	Phase III

MedlinePlus related topics: Hepatitis Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Inactivated Hepatitis A Vaccine Containing 1440 EL.U of Antigen Per ml and Injected According to a 0, 12 Month Schedule in Healthy Adult Volunteers.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HAV antibody concentrations [ Time Frame: at Months 138, 150, 162, 174 and 186 after the first vaccine dose of two-dose primary vaccination ]

Secondary Outcome Measures:

Anti-HAV antibody concentrations [ Time Frame: before and 1 month after the additional vaccination ]
Serious adverse events (SAEs) determined by the investigator to have a causal relationship to vaccination and lack of vaccine efficacy [ Time Frame: Months 138, 150, 162, 174 and 186, ]
Occurrence of solicited local symptoms [ Time Frame: during the 4-day follow-up period after vaccination ]
Occurrence of solicited general symptoms [ Time Frame: during the 4-day follow-up period after vaccination ]
Occurrence, intensity and causal relationship of unsolicited symptoms [ Time Frame: during the 30-day follow-up period after vaccination ]
SAEs [ Time Frame: during the follow-up period after additional vaccination ]

Enrollment:	107
Study Start Date:	January 2004
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Subjects received 2 doses of Havrix™ in the primary study	Biological: Havrix™ 2 doses at 12 months interval
Group B: Experimental Subjects received 2 doses of Havrix™ in the primary study	Biological: Havrix™ 2 doses at 12 months interval

Detailed Description:

This is a long-term follow-up study at Months 138, 150, 162, 174 and 186 after primary vaccination with GSK Biologicals' hepatitis A vaccine (two-dose schedule). To evaluate the long-term antibody persistence, volunteers will be bled at Months 138, 150, 162, 174 and 186 after the first vaccine dose of the primary vaccination course to determine their anti-HAV antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies during any of the long-term blood sampling time point (i.e. Months 138, 150, 162, 174 or 186), he/ she will be offered an additional vaccine dose. A blood sample will be taken on the day of the additional vaccination and after one month to evaluate the immune response following this vaccination.

Eligibility

Ages Eligible for Study:	29 Years to 51 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who had received at least one dose of the study vaccine in the primary study
Written informed consent will have been obtained from the subjects before the blood sampling visit of each year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291876

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:	100571 (M138), 100572 (M150), 100573 (M162), 100574 (M174), 100575 (M186)
Study First Received:	February 14, 2006
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00291876
Health Authority:	Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Hepatitis A
HAVRIX™

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Picornaviridae Infections

Hepatitis, Viral, Human
Hepatitis A
Healthy
Enterovirus Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009