Clinical trial NCT00197119: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Hepatitis A
Keywords: Hepatitis B
TWINRIX™ Adult
Hepatitis A
TWINRIX™ Junior
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 244
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

• none

Primary outcomes:
measure: Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value
timeFrame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
measure: Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value
timeFrame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination
measure: Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)
timeFrame: From Year 6 through to Year 10
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.