Twinrix Alternative Schedule Study

IDEWE Occupational Health Services400 enrolled

Overview

To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months. 1. To compare the seroconversion (\>= 1 IU/l) and seroprotection (\>= 10 IU/l) rate at month 6,7,12 and 13. 2. To compare the distribution of anti-HBs at these different moments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

400

Conditions

Antibody Response After Vaccination

Interventions

Combined vaccine against hepatitis A and B (Twinrix)BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older; * a good physical condition as confirmed by history and physical examination at entry of the study; * for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen; * all participants have provided written informed consent. Exclusion Criteria: * Employees occupationally exposed to hepatitis B virus * Other exclusion criteria listed for the vaccine (licensed vaccine): * Each acute disease at the inclusion in the study; * A history of hypersensibility to one of the components of the vaccine; * Simultaneous participation in another clinical trial

Locations (1)

IDEWE

Leuven, Belgium

Outcomes

Primary Outcomes

Anti-HBs antibodies concentration 1 month after 3th vaccine dose

Secondary Outcomes

Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)

Data from ClinicalTrials.gov

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