Last updated: 11/06/2018 23:24:20

Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,1,6 Month Schedule

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GSK study ID

100556 (Y11)

See study documents

Clinicaltrials.gov ID

NCT00289718

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Completed

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers

Trial description: The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 11, 12, 13, 14 and 15 years after subjects received their first dose of a 3 dose vaccination schedule of combined hepatitis A/hepatitis B 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 to 15.

Primary purpose:

Prevention

Trial design:

Single Group Assignment

Masking:

None (Open Label)

Allocation:

Not applicable

Primary outcomes:

Anti-hepatitis A Virus (Anti-HAV) antibody concentration

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of subjects reporting any and grade 3 solicited local symptoms.

Timeframe: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination

Number of subjects seropositive for anti-HAV antibodies

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Anti-hepatitis B surface antigen (Anti-HBs) antibody concentration

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of subjects seropositive for anti-HB antibodies

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of subjects seroprotected for anti-HBs antibodies.

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Number of Subjects Reporting Serious Adverse Events (SAE)

Timeframe: During the follow-up period after additional vaccination (minimum 30 days)

Anti-Hepatitis B surface antigen (Anti-HBs) antibody concentration

Timeframe: Before the additional dose and 1 month after the additional dose

Number of subjects reporting any solicited general symptoms.

Timeframe: During the 4-day (Day 0-3) follow-up period after additional HBV vaccination

Number of Subjects Reporting Unsolicited Adverse Events (AE)

Timeframe: During the 30-day follow-up period after additional vaccination

Number of subjects reporting serious adverse events (SAEs)

Timeframe: At Years 11, 12, 13, 14, and 15 after the first vaccine dose of the 3-dose primary vaccination

Secondary outcomes:

Not applicable

Interventions:

Biological/vaccine: Twinrix™ adult

Enrollment:

Observational study model:

Not applicable

Primary completion date:

2005-02-03

Time perspective:

Not applicable

Clinical publications:

Van Damme P et al. (2000) Long-Term persistence of antibodies induced by vaccination and safety Follow-Up, with the first combined vaccine against hepatitis A and B in children and adults. J Med Virol. 65 (1):6-13.

Van Damme P et al. (2012) Antibody persistence and immune memory in adults, 15 years after a three-dose schedule of a combined hepatitis A and B vaccine. J Med Virol. 84(1):11-17.

Van Herck et al. (2007) Ten-year antibody persistence induced by hepatitis A and B vaccine (Twinrix) in adults. Travel Medicine and Infectious Disease. 5(3):171-175.

Medical condition

Hepatitis B

Product

SB208127

Collaborators

Not applicable

Study date(s)

November 2004 to March 2005

Type

Interventional

Phase

Participation criteria

Sex

Female & Male

Age

18+ years

Accepts healthy volunteers

Yes

Inclusion Criteria:
Subjects participating in this study should have received three-dose primary vaccination with combined hepatitis A/hepatitis B vaccine in the primary study.

Trial location(s)

Location

Status

Location

GSK Investigational Site

Gent, Belgium, 9000

Status

Study Complete

Study documents

Clinical study report

Available language(s): English

Download document(s)

Scientific result summary

Available language(s): English

Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status

Completed

Actual primary completion date

2005-02-03

Actual study completion date

2005-02-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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