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Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

NCT ID: NCT00383383

Last Updated: 2006-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Brief Summary

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Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.

Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Hepatitis B adjuvanted vaccine

Intervention Type BIOLOGICAL

Engerix-B

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female \> = 15 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject.
* Seronegative for anti-HBs antibodies, anti-HBc antibodies \& Hepatitis B Surface antigen (HBsAg).
* If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
* Pre-haemodialysis patient\* or a patient on haemodialysis.

Exclusion Criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
* Previous vaccination against hepatitis B.
* History of hepatitis B infection.
* Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
* Clinically abnormal ALT/AST values (\> 3 times normal values)
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Hradec, Králové, Czechia

Site Status

GSK Clinical Trials Call Center

Kuala Lumpur, , Malaysia

Site Status

GSK Clinical Trials Call Center

Málaga, , Spain

Site Status

Countries

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Czechia Malaysia Spain

Other Identifiers

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208129/042

Identifier Type: -

Identifier Source: org_study_id