NCT00697242

Brief Summary

In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects

Trial Health

90
On Track

Trial Health Score

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

Enrollment
362

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 1994

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1995

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1995

Completed
12.6 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

1.8 years

First QC Date

June 11, 2008

Last Update Submit

June 11, 2008

Conditions

Hepatitis B

Keywords

Hepatitis BEngerix™-BRecombinant Hepatitis B vaccine

Outcome Measures

Primary Outcomes (1)

  • Anti-hepatitis B surface antigen (HBs) antibody concentrations

    At M2 and M7

Secondary Outcomes (6)

  • Anti-pre-S1 antibody concentrations

    Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation

  • Anti-HBs antibody concentrations

    Screening, Months 1, 2, 3, 6, 7, 8 and 12

  • Occurrence and intensity of local and general solicited symptoms

    4-day after vaccination

  • Cell mediated immunity

    Month 0, Month 2 and month 7

  • Occurrence of unsolicited adverse events

    30 days after vaccination

  • +1 more secondary outcomes

Study Arms (5)

Group A

EXPERIMENTAL
Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Group B

EXPERIMENTAL
Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Group C

EXPERIMENTAL
Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Group D

ACTIVE COMPARATOR
Biological: Engerix™-B

Group E

EXPERIMENTAL
Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL

Interventions

Engerix™-BBIOLOGICAL

Intramuscular injection, 3 doses

Group D
Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPLBIOLOGICAL

Intramuscular injection, 3 doses

Group AGroup BGroup CGroup E

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female subjects between 50 and 70 years old.
  • Written informed consent will have been obtained from the subjects.
  • Good physical condition as established by physical examination and history taking at the time of entry

You may not qualify if:

  • Positive titres for anti hepatitis antibodies
  • Any vaccination against hepatitis B in the past.
  • Any previous administration of MPL
  • Elevated serum liver enzymes at two subsequent determinations 14 days apart.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Axillary temperature \> 37.5°C at the time of injection.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • Any treatment with immunosuppressive or immunostimulant therapy.
  • History of allergic disease likely to be stimulated by any component of the vaccine.
  • Administration of any other vaccine(s) or any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Clinical Trials Call Center

Vienna, Austria

Location

GSK Clinical Trials Call Center

Ghent, Belgium

Location

GSK Clinical Trials Call Center

Hvidovre, Denmark

Location

GSK Clinical Trials Call Center

Reykjavik, Iceland

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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

January 1, 1994

Primary Completion

November 1, 1995

Study Completion

November 1, 1995

Last Updated

June 13, 2008

Record last verified: 2008-06

Locations

BE(1)AU(1)IC(1)DK(1)