Twinrix Alternative Schedule Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Antibody Response After Vaccination

Keywords

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combined hepatitis A and B vaccine hepatitis B virus immunity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Combined vaccine against hepatitis A and B (Twinrix)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Antoon A De Schryver, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

IDEWE Occupational Health Services

Locations

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IDEWE

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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04-033

Identifier Type: -

Identifier Source: secondary_id

IDEWE-301