Twinrix Alternative Schedule Study

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • IDEWE Occupational Health Services
  • Collaborator
    • GlaxoSmithKline
  • Overall Official(s)
    • Antoon A De Schryver, M.D., PhD, Principal Investigator, IDEWE Occupational Health Services

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.