Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years
Evaluate Persistence of Immune Response of GSK Biologicals' TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 Years at Time of First Vaccine Dose
5 other identifiers
interventional
244
2 countries
2
Brief Summary
To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2004
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedResults Posted
Study results publicly available
August 14, 2009
CompletedApril 20, 2017
March 1, 2017
1 month
September 14, 2005
July 2, 2009
March 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value
Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).
Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value
Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.
Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
From Year 6 through to Year 10
Study Arms (2)
Group Twinrix Adult
ACTIVE COMPARATORSubjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Group Twinrix Junior
ACTIVE COMPARATORSubjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
Interventions
Intramuscular administration in the deltoid region (2 doses).
Intramuscular administration in the deltoid region (3 doses).
Eligibility Criteria
You may qualify if:
- Healthy male and female volunteers vaccinated in study HAB-084.
- Written informed consent obtained from the subject before the blood sampling visit of each year.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Hradec Králové, 500 03, Czechia
Related Publications (1)
Beran J, Kervyn D, Wertzova V, Hobzova L, Tichy P, Kuriyakose S, Leyssen M, Jacquet JM. Comparison of long-term (10 years) immunogenicity of two- and three-dose regimens of a combined hepatitis A and B vaccine in adolescents. Vaccine. 2010 Aug 23;28(37):5993-7. doi: 10.1016/j.vaccine.2010.06.104. Epub 2010 Jul 15.
PMID: 20637766BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 20, 2005
Study Start
May 1, 2004
Primary Completion
June 1, 2004
Study Completion
June 1, 2004
Last Updated
April 20, 2017
Results First Posted
August 14, 2009
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.