NCT00383383

Brief Summary

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

Trial Health

85
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
3 countries

3 active sites

Status
completed

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

December 1, 1999

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2006

Completed
Last Updated

October 3, 2006

Status Verified

October 1, 2006

First QC Date

October 2, 2006

Last Update Submit

October 2, 2006

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Anti-HBs seroprotection rates at Month 12.

Secondary Outcomes (1)

  • Solicited symptoms, unsolicited symptoms and serious adverse events

Interventions

Hepatitis B adjuvanted vaccineBIOLOGICAL
Engerix-BBIOLOGICAL

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Clinical Trials Call Center

Hradec, Králové, Czechia

Location

GSK Clinical Trials Call Center

Kuala Lumpur, Malaysia

Location

GSK Clinical Trials Call Center

Málaga, Spain

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 3, 2006

Study Start

December 1, 1999

Last Updated

October 3, 2006

Record last verified: 2006-10

Locations

CZ(1)MY(1)ES(1)