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

Phase 3CompletedNCT00197119

GlaxoSmithKline244 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

244

Conditions

Hepatitis B Hepatitis A

Interventions

Twinrix™ AdultBIOLOGICAL

Intramuscular administration in the deltoid region (2 doses).

Twinrix™ JuniorBIOLOGICAL

Intramuscular administration in the deltoid region (3 doses).

Eligibility

Sex: ALLMin age: 12 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Hradec Králové, Czechia

Outcomes

Primary Outcomes

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).

Time frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination

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.

Time frame: Year 6, 7, 8, 9 and 10 after the first vaccine dose of a two-dose or three-dose primary vaccination

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.

Time frame: From Year 6 through to Year 10

Data from ClinicalTrials.gov

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