Twinrix Alternative Schedule Study | NCT00216229

Studies
Twinrix Alternative Schedule Study

NCT00216229

Sponsor

IDEWE Occupational Health Services

Status

Unknown status

Last Update Posted

Dec 14, 2005Estimated

Enrollment

400

Phase

Phase 4

Conditions

Antibody Response After Vaccination

Interventions

Combined vaccine against hepatitis A and B (Twinrix)

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
04-033

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2005

Last Update Posted Date

Dec 14, 2005Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
Combined vaccine against hepatitis A and B (Twinrix)	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-HBs antibodies concentration 1 month after 3th vaccine dose

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antoon A De Schryver, M.D., PhD	IDEWE Occupational Health Services	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IDEWE		Leuven		B-3001	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C433226	twinrix

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided