NCT00216229

Brief 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. 1.To compare the seroconversion (\>= 1 IU/l) and seroprotection (\>= 10 IU/l) rate at month 6,7,12 and 13.
  2. 2.To compare the distribution of anti-HBs at these different moments.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

December 14, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

December 13, 2005

Conditions

Antibody Response After Vaccination

Keywords

combined hepatitis A and B vaccinehepatitis B virusimmunity

Outcome Measures

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)

Interventions

Combined vaccine against hepatitis A and B (Twinrix)BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Employees occupationally exposed to hepatitis B virus
  • A history of hypersensibility to one of the components of the vaccine;
  • Simultaneous participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDEWE

Leuven, B-3001, Belgium

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

twinrix

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Antoon A De Schryver, M.D., PhD

    IDEWE Occupational Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

September 1, 2004

Study Completion

February 1, 2006

Last Updated

December 14, 2005

Record last verified: 2005-09

Locations

BE(1)