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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,303

participants targeted

Target at P75+ for phase_3

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed

8.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed

Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

10 months

First QC Date

June 11, 2008

Last Update Submit

June 11, 2008

Conditions

Hepatitis B

Keywords

Hepatitis BAdjuvanted Hepatitis B vaccineRecombinant Hepatitis B vaccine

Outcome Measures

Primary Outcomes (3)

Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Full course of vaccination
Incidence of serious adverse events
Study period
Anti-HBs antibody concentrations
At Month 7

Secondary Outcomes (5)

Occurrence and intensity of solicited local signs and symptoms
4-day after vaccination
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
4-day after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
30 days after vaccination
Occurrence and relationship to vaccination of SAEs
During the study period
Anti-HBs antibody concentrations
At Months 1, 2, 6 and 7

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Biological: Engerix™-B

Group B

EXPERIMENTAL

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

Biological: HBV-MPL vaccine 208129

Group C

EXPERIMENTAL

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

Biological: HBV-MPL vaccine 208129

Group D

EXPERIMENTAL

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

Biological: HBV-MPL vaccine 208129

Interventions

HBV-MPL vaccine 208129BIOLOGICAL

2-dose intramuscular injection 3 different vaccine lots

Group BGroup CGroup D

Engerix™-BBIOLOGICAL

3-dose intramuscular injection

Group A

Eligibility Criteria

Age15 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.