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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00343915




Trial ID
NCT00343915
Ethics application status
Date submitted
14/09/2005
Date registered
22/06/2006
Date last updated
29/09/2016

Titles & IDs
Public title
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
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
Secondary ID [1] 0 0
101696
Secondary ID [2] 0 0
101695 Ext. Mth30
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. - A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.
Timepoint [1] 0 0
At Month 7
Primary outcome [2] 0 0
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. - A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.
Timepoint [2] 0 0
At Month 30, Month 42, Month 54 and Month 66
Primary outcome [3] 0 0
Antibody Titers Against Hepatitis-B Virus. - Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Timepoint [3] 0 0
At Month 30, Month 42, Month 54 and Month 66
Secondary outcome [1] 0 0
Antibody Titers Against Hepatitis-B Virus. - Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Timepoint [1] 0 0
At Months 1, 2, 6 and 7
Secondary outcome [2] 0 0
Number of Subjects Seroprotected for Anti-HBs Antibody. - A seroprotected subject was defined as a subject with anti-HBs antibody concentrations = 10 mIU/mL.
Timepoint [2] 0 0
At Months 1, 2 and 6
Secondary outcome [3] 0 0
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - 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.
Timepoint [3] 0 0
During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Secondary outcome [4] 0 0
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. - 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.
Timepoint [4] 0 0
During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Secondary outcome [5] 0 0
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). - 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.
Timepoint [5] 0 0
During the 31-day (Day 0-30) follow-up period after each vaccination and overall
Secondary outcome [6] 0 0
Number of Subjects With Serious Adverse Events (SAEs) - 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.
Timepoint [6] 0 0
During the entire study period (Month 0 to Month 66)
Secondary outcome [7] 0 0
Number of Subjects With Serious Adverse Events (SAEs). - 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.
Timepoint [7] 0 0
At Month 30, Month 42, Month 54 & Month 66

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
Minimum age
13 Years
Maximum age
20 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Wilrijk
Country [3] 0 0
Ukraine
State/province [3] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00343915
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. Epub 2006 Dec 29.
Heron L et al. Randomised control trial: 2-vs 3-dose hepatitis B immunization of adolescents. Abstract presented at the 12th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Paris, France, 1-5 July 2006.
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.
Heron LG et al. A novel hepatitis B vaccination regimen for adolescents - 2 doses 12 months apart. Abstract presented at the 10th ICID Singapore, Bangkok, March 2002.
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.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries