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Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

Engerix™-B

HBV-MPL 208129

Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation

About this trial

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

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Between 18 and 40 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.
Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

Pregnancy or lactation.
Positive titres for anti HBs antibody.
Any vaccination against hepatitis B in the past.
Any previous administration of MPL.
Elevated serum liver enzymes.
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.
Simultaneous administration of any other vaccine(s).
Administration of any immunoglobulin during the study period.
Simultaneous participation in any other clinical trial.

Sites / Locations

GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentrations

Occurrence and intensity of solicited local and general symptoms

Occurrence of unsolicited adverse events

Incidence of serious adverse events

Anti-Hbs antibody concentrations

Secondary Outcome Measures

Full Information

NCT ID

NCT00697840

First Posted

June 12, 2008

Last Updated

June 13, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697840

Brief Title

Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

Official Title

Study to Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

June 1995 (undefined)

Primary Completion Date

January 1996 (Actual)

Study Completion Date

January 1996 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

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, Adjuvant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Active Comparator

Arm Title

Group C

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

Intramuscular injection, 2 doses

Intervention Type

Biological

Intervention Name(s)

HBV-MPL 208129

Intervention Description

Intramuscular injection, 2 doses

Intervention Type

Biological

Intervention Name(s)

Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation

Intervention Description

Intramuscular injection, 2 doses; experimental formulation

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

At month 7

Title

Occurrence and intensity of solicited local and general symptoms

Time Frame

4-day follow-up after vaccination

Title

Occurrence of unsolicited adverse events

Time Frame

30-days after vaccination

Title

Incidence of serious adverse events

Time Frame

Throughout the study period

Title

Anti-Hbs antibody concentrations

Time Frame

Months 1, 6 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Between 18 and 40 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. Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry Exclusion Criteria: Pregnancy or lactation. Positive titres for anti HBs antibody. Any vaccination against hepatitis B in the past. Any previous administration of MPL. Elevated serum liver enzymes. 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. Simultaneous administration of any other vaccine(s). Administration of 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

Vienna

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

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