Last updated: 11/06/2018 23:24:00
Long-term immune persistence of GSK Biologicals' combined hepatitis A & B vaccine injected according to a 0,1,6 mth schedule in healthy adults
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults
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 after subjects received their first dose of a 3 dose primary 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 11-15.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of subjects with anti-hepatitis A (anti-HAV) antibody concentrations equal to or above cut-off value
Timeframe: Years 11, 12, 13, 14 and 15
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations equal to or above cut-off values
Timeframe: Years 11, 12, 13, 14 and 15
Anti-HAV and anti-HBs antibody concentrations
Timeframe: Years 11, 12, 13, 14 and 15
Anti-HBs antibody concentrations
Timeframe: at Year 11, pre-additional vaccine, after additional dose of Engerix
Number of subjects, receiving an additional vaccination of Engerix, with an anamnestic response
Timeframe: 30 days post additional dose of Engerix
Number of subjects with solicited local and general symptoms assessed
Timeframe: During the 4-day follow-up period after additional vaccination with Engerix
Number of subjects with unsolicited symptoms
Timeframe: During the 30-day follow-up period after additional Engerix vaccination
Number of subjects with Serious Adverse Events (SAEs)
Timeframe: During the 30-day follow-up period after additional Engerix vaccination
Number of subjects with serious adverse events (SAEs) determined by the investigator to have a causal relationship to primary vaccination or due to lack of vaccine efficacy
Timeframe: up to Year 11, 12, 13, 14, 15
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Twinrix™
Enrollment:
50
Observational study model:
Not applicable
Primary completion date:
2004-20-12
Time perspective:
Not applicable
Clinical publications:
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 Damme P. et al. (2001) 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 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 December 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who had consented to participate in the long-term follow-up studies at the previous long-term blood sampling time points
- Written informed consent will have been obtained from each subject. before the blood sampling visit of each year.
Inclusion Criteria:
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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
2004-20-12
Actual study completion date
2004-20-12
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.
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