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Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

HBV-MPL vaccine 208129

Engerix™-B

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 - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
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 parent or guardian of the subject.
If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment 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.
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 non-response to previous hepatitis B vaccination.
Known exposure to hepatitis B within the past 6 weeks.
History of hepatitis B infection.
Confirmed 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.
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

Sites / Locations

GSK Clinical Trials Call Center
GSK Clinical Trials Call Center
GSK Clinical Trials Call Center
GSK Clinical Trials Call Center
GSK Clinical Trials Call Center
GSK Clinical Trials Call Center
GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

Three doses according to 0, 1, 6-month schedule

Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Outcomes

Primary Outcome Measures

Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms

Incidence of serious adverse events

Anti-HBs antibody concentrations

Secondary Outcome Measures

Occurrence and intensity of solicited local signs and symptoms

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

Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms

Occurrence and relationship to vaccination of SAEs

Anti-HBs antibody concentrations

Full Information

NCT ID

NCT00696917

First Posted

June 11, 2008

Last Updated

June 11, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00696917

Brief Title

Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

Official Title

Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

April 1999 (undefined)

Primary Completion Date

February 2000 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.

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, Adjuvanted Hepatitis B vaccine, Recombinant Hepatitis B vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1303 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

Three doses according to 0, 1, 6-month schedule

Arm Title

Group B

Arm Type

Experimental

Arm Description

Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Arm Title

Group C

Arm Type

Experimental

Arm Description

Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Arm Title

Group D

Arm Type

Experimental

Arm Description

Two doses according to 0, 6-month schedule, with a placebo injection at Month 1

Intervention Type

Biological

Intervention Name(s)

HBV-MPL vaccine 208129

Intervention Description

2-dose intramuscular injection 3 different vaccine lots

Intervention Type

Biological

Intervention Name(s)

Engerix™-B

Intervention Description

3-dose intramuscular injection

Primary Outcome Measure Information:

Title

Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms

Time Frame

Full course of vaccination

Title

Incidence of serious adverse events

Time Frame

Study period

Title

Anti-HBs antibody concentrations

Time Frame

At Month 7

Secondary Outcome Measure Information:

Title

Occurrence and intensity of solicited local signs and symptoms

Time Frame

4-day after vaccination

Title

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

Time Frame

4-day after vaccination

Title

Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms

Time Frame

30 days after vaccination

Title

Occurrence and relationship to vaccination of SAEs

Time Frame

During the study period

Title

Anti-HBs antibody concentrations

Time Frame

At Months 1, 2, 6 and 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled. 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 parent or guardian of the subject. If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment 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. 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 non-response to previous hepatitis B vaccination. Known exposure to hepatitis B within the past 6 weeks. History of hepatitis B infection. Confirmed 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. 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

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

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

GSK Clinical Trials Call Center

City

Hradec Kralové

Country

Czech Republic

Facility Name

GSK Clinical Trials Call Center

City

München

Country

Germany

Facility Name

GSK Clinical Trials Call Center

City

Bari

Country

Italy

Facility Name

GSK Clinical Trials Call Center

City

Utrecht

Country

Netherlands

Facility Name

GSK Clinical Trials Call Center

City

Lausanne

Country

Switzerland

Facility Name

GSK Clinical Trials Call Center

City

London

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y

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