Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

951 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Brief Summary

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The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.

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Detailed Description

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Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

HBV-MPL Lot A

Group Type EXPERIMENTAL

HBV-MPL vaccine 208129

Intervention Type BIOLOGICAL

3 consecutive lots; 3-dose intramuscular injection

Group B

HBV-MPL Lot B

Group Type EXPERIMENTAL

HBV-MPL vaccine 208129

Intervention Type BIOLOGICAL

3 consecutive lots; 3-dose intramuscular injection

Group C

HBV-MPL Lot C

Group Type EXPERIMENTAL

HBV-MPL vaccine 208129

Intervention Type BIOLOGICAL

3 consecutive lots; 3-dose intramuscular injection

Group D

Engerix™-B

Group Type ACTIVE_COMPARATOR

Engerix™-B

Intervention Type BIOLOGICAL

3-dose intramuscular injection

Interventions

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HBV-MPL vaccine 208129

3 consecutive lots; 3-dose intramuscular injection

Intervention Type BIOLOGICAL

Engerix™-B

3-dose intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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HBV-MPL vaccine 208129

Eligibility Criteria

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Inclusion Criteria

* A male or female between, and including, 15 and 50 years of age at the time of the first vaccination.
* Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days 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) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
* Previous vaccination against hepatitis B
* History of non-response to previous hepatitis B vaccination
* Known exposure to hepatitis B within the previous 6 weeks
* History of hepatitis B infection
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* 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 during the study period.
* Pregnant or lactating female

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes