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Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Engerix™-B

HBV-MPL vaccine 208129

About this trial

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

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

GSK Clinical Trial Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentrations

Secondary Outcome Measures

Anti-HBs antibody concentrations

Occurrence and intensity of solicited local and general symptoms

Occurrence, intensity and relationship to vaccination of unsolicited symptoms

Occurrence, intensity and relationship to vaccination of SAEs

Full Information

NCT ID

NCT00697853

First Posted

June 12, 2008

Last Updated

June 13, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697853

Brief Title

Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults

Official Title

Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine Administered According to a 0, 6 Month Schedule and of Engerix™-B Administered According to a 0, 1, 6 Month Schedule in Healthy Adults

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

November 1998 (undefined)

Primary Completion Date

July 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 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

Detailed Description

This is an open, randomized study with five groups, but the four groups receiving HBV-MPL candidate vaccine are double-blinded. 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, Adjuvanted hepatitis B vaccine, Recombinant hepatitis B vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Title

Group B

Arm Type

Experimental

Arm Title

Group C

Arm Type

Experimental

Arm Title

Group D

Arm Type

Experimental

Arm Title

Group E

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

3-dose intramuscular injection

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine 208129

Intervention Description

2-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 and 6

Title

Occurrence and intensity of solicited local and general symptoms

Time Frame

4-day follow-up period after each vaccination

Title

Occurrence, intensity and relationship to vaccination of unsolicited symptoms

Time Frame

30-day follow-up period after each vaccination

Title

Occurrence, intensity and relationship to vaccination of SAEs

Time Frame

Throughout the entire study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

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 Trial Call Center

City

Brussels

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine (2 Doses), and of Engerix™-B (3 Doses) in Healthy Adults

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