NCT00697853

Brief Summary

This study is undertaken to assess the immune response and safety profile of 4 lots of the novel adjuvanted hepatitis B vaccine that were formulated following different processes, with Engerix™-B as the control vaccine

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

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

November 1, 1998

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1999

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2008

Completed
Last Updated

June 16, 2008

Status Verified

June 1, 2008

Enrollment Period

8 months

First QC Date

June 12, 2008

Last Update Submit

June 13, 2008

Conditions

Hepatitis B

Keywords

Hepatitis BAdjuvanted hepatitis B vaccineRecombinant hepatitis B vaccine

Outcome Measures

Primary Outcomes (1)

  • Anti-HBs antibody concentrations

    At month 7

Secondary Outcomes (4)

  • Anti-HBs antibody concentrations

    At months 1, 2 and 6

  • Occurrence and intensity of solicited local and general symptoms

    4-day follow-up period after each vaccination

  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms

    30-day follow-up period after each vaccination

  • Occurrence, intensity and relationship to vaccination of SAEs

    Throughout the entire study

Study Arms (5)

Group A

ACTIVE COMPARATOR
Biological: Engerix™-B

Group B

EXPERIMENTAL
Biological: HBV-MPL vaccine 208129

Group C

EXPERIMENTAL
Biological: HBV-MPL vaccine 208129

Group D

EXPERIMENTAL
Biological: HBV-MPL vaccine 208129

Group E

EXPERIMENTAL
Biological: HBV-MPL vaccine 208129

Interventions

Engerix™-BBIOLOGICAL

3-dose intramuscular injection

Group A
HBV-MPL vaccine 208129BIOLOGICAL

2-dose intramuscular injection

Group BGroup CGroup DGroup E

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A male or female between 15 and 50 years of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the subject and/or from the parents or guardians of the subject.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to vaccination and up to two months after the last vaccination

You may not qualify if:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
  • Previous vaccination against hepatitis B.
  • History of significant and persisting hematological, hepatic, renal, cardiac or respiratory disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrollment.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Oral temperature of ≥37.5°C (99.5°F).
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or intravenous drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Clinical Trial Call Center

Brussels, Belgium

Location

MeSH Terms

Conditions

Hepatitis 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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 16, 2008

Study Start

November 1, 1998

Primary Completion

July 1, 1999

Last Updated

June 16, 2008

Record last verified: 2008-06

Locations

BE(1)