Back to results

Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

HBsAg formulated with different concentrations of MPL and Aluminium Salts

Engerix™-B

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.
Positivity for anti hepatitis antibodies.
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.
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 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Arm Description

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentrations

Secondary Outcome Measures

Occurrence and intensity of local and general solicited symptoms

Anti-HBs antibody concentrations

Occurrence of unsolicited adverse events

Occurrence of serious adverse events

Full Information

NCT ID

NCT00697970

First Posted

June 12, 2008

Last Updated

June 13, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697970

Brief Title

Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

November 1993 (undefined)

Primary Completion Date

April 1995 (Actual)

Study Completion Date

April 1995 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12

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

321 (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

Experimental

Arm Title

Group E

Arm Type

Experimental

Arm Title

Group F

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

HBsAg formulated with different concentrations of MPL and Aluminium Salts

Intervention Description

Intramuscular injection, 3 doses

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

Intramuscular injection, 3 doses

Primary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

After two doses and after the booster dose

Secondary Outcome Measure Information:

Title

Occurrence and intensity of local and general solicited symptoms

Time Frame

8 days after vaccination

Title

Anti-HBs antibody concentrations

Time Frame

Screening, M1, 2, 3, 4, 6, 12, 13

Title

Occurrence of unsolicited adverse events

Time Frame

30-day after vaccination

Title

Occurrence of serious adverse events

Time Frame

During the study period and 30 days after the 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. Positivity for anti hepatitis antibodies. 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. 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

Vienna

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

We'll reach out to this number within 24 hrs