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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Hepatitis A; Hepatitis B

Treatments: Biological: Twinrix™ Adult; Biological: Twinrix™ Junior

Study type: Interventional

Funder types: Industry

Identifiers

NCT00197119

100566

100569 (Other Identifier)

100570 (Other Identifier)

100567 (Other Identifier)

100568 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 patients

Sex: All

Ages: 12 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

Group Twinrix Adult

Active Comparator group

Description:

Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.

Treatment:

Biological: Twinrix™ Adult

Group Twinrix Junior

Active Comparator group

Description:

Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.

Treatment:

Biological: Twinrix™ Junior