Back to resultsTwinrix Alternative Schedule Study
Primary Purpose
Antibody Response After Vaccination
Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Combined vaccine against hepatitis A and B (Twinrix)
Sponsored by
About this trial
This is an interventional prevention trial for Antibody Response After Vaccination focused on measuring combined hepatitis A and B vaccine, hepatitis B virus, immunity
Eligibility Criteria
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
Sites / Locations
- IDEWE
Outcomes
Primary Outcome Measures
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Secondary Outcome Measures
Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
Full Information
NCT ID
NCT00216229
First Posted
September 12, 2005
Last Updated
December 13, 2005
Sponsor
IDEWE Occupational Health Services
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00216229
Brief Title
Twinrix Alternative Schedule Study
Official Title
A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
IDEWE Occupational Health Services
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
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.
To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month 6,7,12 and 13.
To compare the distribution of anti-HBs at these different moments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibody Response After Vaccination
Keywords
combined hepatitis A and B vaccine, hepatitis B virus, immunity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Combined vaccine against hepatitis A and B (Twinrix)
Primary Outcome Measure Information:
Title
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
Secondary Outcome Measure Information:
Title
Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoon A De Schryver, M.D., PhD
Organizational Affiliation
IDEWE Occupational Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDEWE
City
Leuven
ZIP/Postal Code
B-3001
Country
Belgium
12. IPD Sharing Statement
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Twinrix Alternative Schedule Study
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