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Status unknownNCT00216229Updated Dec 14, 2005

Twinrix Alternative Schedule Study

A Phase 4 interventional study of Combined vaccine against hepatitis A and B (Twinrix) in Antibody Response After Vaccination, sponsored by IDEWE Occupational Health Services. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-12-14.

Sponsored by IDEWE Occupational Health Services · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2005), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Antibody Response After Vaccination

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Keywords

  • combined hepatitis A and B vaccine
  • hepatitis B virus
  • immunity
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 400 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

This is the only study on the registry with IDEWE Occupational Health Services as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants

Interventions

  • BiologicalCombined vaccine against hepatitis A and B (Twinrix)
06

What researchers measure

Primary outcomes

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

Secondary outcomes

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

07

Study locations

1 site
  • IDEWE
    Leuven, B-3001, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00216229
Lead sponsor
IDEWE Occupational Health Services
Collaborators
GlaxoSmithKline
First posted
Sep 22, 2005
Start date
Sep 2004
Completion
Feb 2006
Last update
Dec 14, 2005

Study contacts

Antoon A De Schryver, M.D., PhD
principal investigator · IDEWE Occupational Health Services
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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