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
|Hepatitis B Hepatitis A||Biological: Twinrix™ Adult Biological: Twinrix™ Junior||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||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|
- Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value [ Time Frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination ]Anti-HAV antibody concentration cut-off value assessed was ≥ 15 milli-International Units per milliliter (mIU/mL).
- Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value [ Time Frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination ]Anti-HBs antibody concentration cut-off value assessed was ≥ 3.3 mIU/mL.
- Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling) [ Time Frame: From Year 6 through to Year 10 ]
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.
|Study Start Date:||May 2004|
|Study Completion Date:||June 2004|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
Active Comparator: Group Twinrix Adult
Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
Biological: Twinrix™ Adult
Intramuscular administration in the deltoid region (2 doses).
Active Comparator: Group Twinrix Junior
Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
Biological: Twinrix™ Junior
Intramuscular administration in the deltoid region (3 doses).
Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197119
|GSK Investigational Site|
|Bruxelles, Belgium, 1200|
|GSK Investigational Site|
|Hradec Kralove, Czech Republic, 500 03|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|