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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197119
• Other study ID #: 100566
• Secondary ID: 1005671005681005
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: November 3, 2011
• Start date: May 2004
• Est. completion date: July 2008

Study information

• Verified date: November 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Twinrix™ Adult
Intramuscular administration in the deltoid region (2 doses).
• Twinrix™ Junior
Intramuscular administration in the deltoid region (3 doses).

Locations

Country	Name	City	State
Czech Republic	GSK Investigational Site	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No