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
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|ClinicalTrials.gov Identifier: NCT00197119|
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : August 14, 2009
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B Hepatitis A||Biological: Twinrix™ Adult Biological: Twinrix™ Junior||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||244 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||June 2004|
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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197119
|GSK Investigational Site|
|Bruxelles, Belgium, 1200|
|GSK Investigational Site|
|Hradec Kralove, Czech Republic, 500 03|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|