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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Treatment: Other - Engerix™-B (thiomersal-free) 20µg
Treatment: Other - 10 µg Engerix™-B (preservative-free)
Treatment: Other - 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.


Treatment: Other: Engerix™-B (thiomersal-free) 20µg
In the primary study: 2 deep intramuscular injections (Months 0, \& 6)

Treatment: Other: 10 µg Engerix™-B (preservative-free)
In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)

Treatment: Other: placebo
In the primary study: 1 deep intramuscular injection (month 1)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
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.
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.
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.
Timepoint [1] 0 0
At Months 1, 2, 6 and 7
Secondary outcome [2] 0 0
Number of Subjects Seroprotected for Anti-HBs Antibody.
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
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.
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).
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)
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).
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
Sex
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
21/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2008
Sample size
Target
Accrual to date
Final
267
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/study/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. 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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00343915