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Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

HBV-MPL vaccine Formulation A

HBV-MPL vaccine Formulation B

Engerix™-B

About this trial

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

Eligibility Criteria

11 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age: between 11 and 15 years 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 parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series

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 of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
Previous vaccination against hepatitis B virus.
Previous vaccination with vaccine containing MPL.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
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.
Axillary temperature of ≥ 37.5° C.
Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
History of chronic disease deemed by the investigator to be relevant.
Positive for anti-HBV antibodies at screening

Sites / Locations

GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

HBV-MPL Formulation A at months 0 and 6

HBV-MPL Formulation B at months 0 and 6

HBV-MPL Formulation A at month 0 and Engerix™-B at month 6

Engerix™-B at months 0, 1, 6

Outcomes

Primary Outcome Measures

Occurrence of Serious adverse experiences (SAE)

Occurrence, intensity and relationship to vaccination of solicited local and general symptoms

Occurrence, intensity and causal relationship of unsolicited adverse events

Secondary Outcome Measures

Anti-HBs antibody concentrations

Cell mediated immunity

Full Information

NCT ID

NCT00697775

First Posted

June 12, 2008

Last Updated

June 13, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697775

Brief Title

Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

Official Title

Study to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

March 1998 (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

In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15

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, Recombinant hepatitis B vaccine, Adjuvant

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

Experimental

Arm Description

HBV-MPL Formulation A at months 0 and 6

Arm Title

Group B

Arm Type

Experimental

Arm Description

HBV-MPL Formulation B at months 0 and 6

Arm Title

Group C

Arm Type

Experimental

Arm Description

HBV-MPL Formulation A at month 0 and Engerix™-B at month 6

Arm Title

Group D

Arm Type

Active Comparator

Arm Description

Engerix™-B at months 0, 1, 6

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine Formulation A

Intervention Description

Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine Formulation B

Intervention Description

2-dose intramuscular injection

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection

Primary Outcome Measure Information:

Title

Occurrence of Serious adverse experiences (SAE)

Time Frame

During the study period

Title

Occurrence, intensity and relationship to vaccination of solicited local and general symptoms

Time Frame

During the 8-day follow-up period after vaccination

Title

Occurrence, intensity and causal relationship of unsolicited adverse events

Time Frame

31-day follow-up period after vaccination

Secondary Outcome Measure Information:

Title

Anti-HBs antibody concentrations

Time Frame

At months 1, 2, 6, and 7

Title

Cell mediated immunity

Time Frame

At months 1, 6, and 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: between 11 and 15 years 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 parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age. If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series 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 of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after. Previous vaccination against hepatitis B virus. Previous vaccination with vaccine containing MPL. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. 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. Axillary temperature of ≥ 37.5° C. Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female. History of chronic disease deemed by the investigator to be relevant. Positive for anti-HBV antibodies at screening

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

Mainz

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

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