Back to results

Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Engerix™-B

HBV-MPL vaccine (208129)

Hepatitis B vaccine, 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

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.
Serological signs of HBV infection
Elevated serum liver enzymes
Any vaccination against hepatitis B in the past.
Any previous administration of MPL.
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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Outcomes

Primary Outcome Measures

Occurrence and intensity of solicited local and general symptoms

Secondary Outcome Measures

Anti-HBs antibody concentrations

Occurrence, intensity of unsolicited adverse events

Occurrence of serious adverse events

Full Information

NCT ID

NCT00697125

First Posted

June 11, 2008

Last Updated

June 11, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697125

Brief Title

Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

Official Title

Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

June 1993 (undefined)

Primary Completion Date

July 1994 (Actual)

Study Completion Date

July 1994 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to evaluate the immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (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

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

Intramuscular injection, 3 doses

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine (208129)

Intervention Type

Biological

Intervention Name(s)

Hepatitis B vaccine, experimental formulation

Intervention Description

Intramuscular injection, 3 doses

Primary Outcome Measure Information:

Title

Occurrence and intensity of solicited local and general symptoms

Time Frame

8 days follow-up after vaccination

Secondary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

Months 0, 1, 3, 6, 7, 8 and 12

Title

Occurrence, intensity of unsolicited adverse events

Time Frame

30-day follow-up after vaccination

Title

Occurrence of serious adverse events

Time Frame

During the study period up to 30 days after last vaccination

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. Serological signs of HBV infection Elevated serum liver enzymes Any vaccination against hepatitis B in the past. Any previous administration of MPL. 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

Gent

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

We'll reach out to this number within 24 hrs