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Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

HBV-MPL vaccine

Engerix™-B

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Age: 50 to 70 years old.
Good physical condition as established by clinical examination and history taking at the time of entry.
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
Written informed consent obtained from the subjects

Exclusion Criteria:

Positive at screening for anti-HBV antibodies.
Elevated serum liver enzymes
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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.
Simultaneous participation in any other clinical trial.
Previous vaccination with a recombinant hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 6 months and during the whole study period
Vaccination one week before and one week after each dose of the study vaccine

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentrations

Secondary Outcome Measures

Anti-HBs antibody concentrations

Occurrence and intensity of solicited local symptoms

Occurrence and intensity and relationship to vaccination of solicited general symptoms

Occurrence and intensity of any symptoms (solicited/ unsolicited).

Occurrence, intensity and causal relationship of unsolicited symptoms

Serious adverse events

Full Information

NCT ID

NCT00696891

First Posted

June 11, 2008

Last Updated

June 11, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00696891

Brief Title

Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

Official Title

Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine With That of Engerix™-B When Both Are Injected According to 3 Dose Schedule (0, 1, 6 Months) in an Adult Population Aged Between 50 and 70 Years

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

June 1997 (undefined)

Primary Completion Date

May 1999 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study is conducted to compare the immunogenicity, reactogenicity and safety of Engerix™-B and HBV-MPL vaccine against hepatitis B infection in an elderly population

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

Adjuvanted hepatitis B vaccine, hepatitis B, Engerix™-B

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

380 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine

Intervention Description

3-dose intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

3-dose intramuscular injection

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

At Month 7

Secondary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

At Months 1, 2, 6, 7 and 12

Title

Occurrence and intensity of solicited local symptoms

Time Frame

4-day follow-up after vaccination

Title

Occurrence and intensity and relationship to vaccination of solicited general symptoms

Time Frame

4-day follow-up after vaccination

Title

Occurrence and intensity of any symptoms (solicited/ unsolicited).

Time Frame

4-day follow-up after vaccination

Title

Occurrence, intensity and causal relationship of unsolicited symptoms

Time Frame

Within 30 days after vaccination

Title

Serious adverse events

Time Frame

Throughout study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 50 to 70 years old. Good physical condition as established by clinical examination and history taking at the time of entry. Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. Written informed consent obtained from the subjects Exclusion Criteria: Positive at screening for anti-HBV antibodies. Elevated serum liver enzymes History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. Any acute disease at the moment of entry. Chronic alcohol consumption. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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. Simultaneous participation in any other clinical trial. Previous vaccination with a recombinant hepatitis B vaccine. Previous vaccination with an MPL containing vaccine. Administration of immunoglobulins in the past 6 months and during the whole study period Vaccination one week before and one week after each dose of the study vaccine

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

Wilrijk

Country

Belgium

Facility Name

GSK Clinical Trials Call Center

City

Toronto

Country

Canada

Facility Name

GSK Clinical Trials Call Center

City

Göteborg

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in Adults

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