Twinrix Alternative Schedule Study

Antibody Response After Vaccination Clinical Trial

Official title:

A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00216229
• Other study ID #: IDEWE-301
• Secondary ID: 04-033
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: December 13, 2005
• Start date: September 2004
• Est. completion date: February 2006

Study information

• Verified date: September 2005
• Source: IDEWE Occupational Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibody Response After Vaccination

Intervention

Biological:
• Combined vaccine against hepatitis A and B (Twinrix)

Locations

Country	Name	City	State
Belgium	IDEWE	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
IDEWE Occupational Health Services	GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Secondary	Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)