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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00343915
Registration number
NCT00343915
Ethics application status
Date submitted
14/09/2005
Date registered
23/06/2006
Date last updated
10/06/2019
Titles & IDs
Public title
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
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Scientific 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
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Secondary ID [1]
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101696
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Secondary ID [2]
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101695 Ext. Mth30
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Engerix™-B (thiomersal-free) 20µg
Other interventions - 10 µg Engerix™-B (preservative-free)
Other interventions - placebo
Experimental: 2-Dose Engerix - subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Active Comparator: 3-Dose Engerix - subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Other interventions: Engerix™-B (thiomersal-free) 20µg
In the primary study: 2 deep intramuscular injections (Months 0, & 6)
Other interventions: 10 µg Engerix™-B (preservative-free)
In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)
Other interventions: placebo
In the primary study: 1 deep intramuscular injection (month 1)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
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Assessment method [1]
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A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.
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Timepoint [1]
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At Month 7
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Primary outcome [2]
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Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
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Assessment method [2]
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A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.
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Timepoint [2]
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At Month 30, Month 42, Month 54 and Month 66
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Primary outcome [3]
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Antibody Titers Against Hepatitis-B Virus.
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Assessment method [3]
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Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
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Timepoint [3]
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At Month 30, Month 42, Month 54 and Month 66
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Secondary outcome [1]
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Antibody Titers Against Hepatitis-B Virus.
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Assessment method [1]
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Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
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Timepoint [1]
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At Months 1, 2, 6 and 7
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Secondary outcome [2]
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Number of Subjects Seroprotected for Anti-HBs Antibody.
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Assessment method [2]
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A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.
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Timepoint [2]
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At Months 1, 2 and 6
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Secondary outcome [3]
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
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Assessment method [3]
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Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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Timepoint [3]
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During the 4-day (Day 0-3) follow-up period after each vaccination and overall
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Secondary outcome [4]
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
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Assessment method [4]
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Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
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Timepoint [4]
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During the 4-day (Day 0-3) follow-up period after each vaccination and overall
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Secondary outcome [5]
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).
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Assessment method [5]
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Timepoint [5]
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During the 31-day (Day 0-30) follow-up period after each vaccination and overall
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Secondary outcome [6]
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Number of Subjects With Serious Adverse Events (SAEs)
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Assessment method [6]
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Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
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Timepoint [6]
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During the entire study period (Month 0 to Month 66)
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Secondary outcome [7]
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Number of Subjects With Serious Adverse Events (SAEs).
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Assessment method [7]
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erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
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Timepoint [7]
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At Month 30, Month 42, Month 54 & Month 66
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Eligibility
Key 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
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Minimum age
13
Years
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Maximum age
20
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/04/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/01/2008
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Sample size
Target
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Accrual to date
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Final
267
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Bruxelles
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Country [2]
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Belgium
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State/province [2]
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Wilrijk
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Country [3]
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Ukraine
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State/province [3]
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Kyiv
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00343915
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Trial related presentations / publications
Heron L, Selnikova O, Moiseieva A, Van Damme P, van der Wielen M, Levie K, Hoet B, Stoffel M. Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial. Vaccine. 2007 Apr 12;25(15):2817-22. doi: 10.1016/j.vaccine.2006.12.021. Epub 2006 Dec 29.
Heron LG, Chant KG, Jalaludin BB. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine. 2002 Oct 4;20(29-30):3472-6. doi: 10.1016/s0264-410x(02)00346-8.
Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. 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. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00343915
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