Last updated: 11/02/2018 23:08:44
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
GSK study ID
100561 (Y6)
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children
Trial description: The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. This protocol posting deals with objectives & outcome measures of the extension phase at year 6 through to 10.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Anti-hepatitis A virus (anti-HAV) antibody concentration
Timeframe: Years 6, 7, 8, 9, and 10.
Anti-hepatitis B surface antigen (anti-HBs) antibody concentration
Timeframe: At Year 6, 7, 8, 9 and 10
Anti-hepatitis B surface antigen (anti-HBs) antibody concentration
Timeframe: Before and 1 month after the additional dose administration
Number of subjects with immune response to the additional dose of Engerix™-B
Timeframe: One month after the additional dose administration
Number of subjects reporting serious adverse events (SAEs) assessed by the investigator as causally related to primary vaccination, study procedures or lack of vaccine efficacy
Timeframe: At Year 6, 7, 8, 9 and 10
Number of subjects reporting solicited local and general symptoms
Timeframe: During the 4-day follow-up period after additional dose
Number of subjects reporting unsolicited adverse events
Timeframe: During the 30-day follow-up period after additional dose
Number of subjects reporting serious adverse events (SAEs)
Timeframe: During the 30-day follow-up period after additional dose
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
178
Primary completion date:
2004-03-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
SB208127
Collaborators
Not applicable
Study date(s)
February 2004 to May 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
7 - 17 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
- Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2004-03-05
Actual study completion date
2004-03-05
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
Additional information
Not applicable
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