Last updated: 02/13/2019 07:22:30
Immuno & safety study of GSK Biologicals' thio or preservative free hepatitis B vaccine in subjects aged 11-15 yrs
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs
Trial description: To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.Subjects were aged 11 to 15 years at the time of the primary vaccination course.At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects seroprotected for anti-hepatitis B surface antigen (anti-HBs) antibody.
Timeframe: At Month 7
Number of subjects seroprotected for anti-hepatitis B surface antigen (anti-HBs) antibody.
Timeframe: At Month 30, Month 42, Month 54 and Month 66
Antibody titers against hepatitis-B virus.
Timeframe: At Month 30, Month 42, Month 54 and Month 66
Secondary outcomes:
Antibody titers against hepatitis-B virus.
Timeframe: At Months 1, 2, 6 and 7
Number of subjects seroprotected for anti-HBs antibody.
Timeframe: At Months 1, 2 and 6
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Number of subjects with any, grade 3 and related solicited general symptoms.
Timeframe: During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Number of subjects reporting any, grade 3 and related unsolicited adverse event (AE).
Timeframe: During the 31-day (Day 0-30) follow-up period after each vaccination and overall
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (Month 0 to Month 66)
Number of subjects with serious adverse events (SAEs).
Timeframe: At Month 30, Month 42, Month 54 & Month 66
Interventions:
Biological/vaccine: Engerix™-B (thiomersal-free) 20µg
Biological/vaccine: 10 μg Engerix™-B (preservative-free)
Biological/vaccine: placebo
Enrollment:
267
Observational study model:
Not applicable
Primary completion date:
2008-10-01
Time perspective:
Not applicable
Clinical publications:
Heron L et al. (2007) Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunization of healthy adolescents aged 11-15 years: A randomized controlled trial. Vaccine. 25(15):2817-2822.
Heron LG et al. (2002) A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine. 20(29-30):3472-3476.
Van Damme P. et al. (2010) Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11–15 years: a randomised controlled study. BMC Infect Dis.10:357.
Medical condition
Hepatitis B
Product
SKF103860
Collaborators
Not applicable
Study date(s)
April 2004 to January 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
13 - 20 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Subjects have participated in primary study HBV-280
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria:
- Subjects have participated in primary study HBV-280
- 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
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
2008-10-01
Actual study completion date
2008-10-01
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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