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Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Engerix™-B
Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
  • 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.

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Outcomes

Primary Outcome Measures

Anti-hepatitis B surface antigen (HBs) antibody concentrations

Secondary Outcome Measures

Anti-pre-S1 antibody concentrations
Anti-HBs antibody concentrations
Occurrence and intensity of local and general solicited symptoms
Cell mediated immunity
Occurrence of unsolicited adverse events
Occurrence of serious adverse events

Full Information

First Posted
June 11, 2008
Last Updated
June 11, 2008
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00697242
Brief Title
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
Official Title
Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 1994 (undefined)
Primary Completion Date
November 1995 (Actual)
Study Completion Date
November 1995 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Arm Title
Group D
Arm Type
Active Comparator
Arm Title
Group E
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Engerix™-B
Intervention Description
Intramuscular injection, 3 doses
Intervention Type
Biological
Intervention Name(s)
Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Intervention Description
Intramuscular injection, 3 doses
Primary Outcome Measure Information:
Title
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time Frame
At M2 and M7
Secondary Outcome Measure Information:
Title
Anti-pre-S1 antibody concentrations
Time Frame
Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Title
Anti-HBs antibody concentrations
Time Frame
Screening, Months 1, 2, 3, 6, 7, 8 and 12
Title
Occurrence and intensity of local and general solicited symptoms
Time Frame
4-day after vaccination
Title
Cell mediated immunity
Time Frame
Month 0, Month 2 and month 7
Title
Occurrence of unsolicited adverse events
Time Frame
30 days after vaccination
Title
Occurrence of serious adverse events
Time Frame
During the study period and 30 days after last vaccine dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Wien
Country
Austria
Facility Name
GSK Clinical Trials Call Center
City
Gent
Country
Belgium
Facility Name
GSK Clinical Trials Call Center
City
Hvidovre
Country
Denmark
Facility Name
GSK Clinical Trials Call Center
City
Reykjavik
Country
Iceland

12. IPD Sharing Statement

Learn more about this trial

Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

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