Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-24

Study Completion Date

2004-12-21

Brief Summary

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The focus of this study is to evaluate how risk factors like age, gender, body mass index, smoking, alcohol consumption, etc. can influence immune response when subjects are vaccinated with GSK Biologicals' combined hepatitis A/hepatitis B vaccine or monovalent hepatitis A and B vaccines (from GSK Biologicals' or different manufacturers). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Detailed Description

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The study will also evaluate the persistence of hepatitis A and hepatitis B antibodies at months 12, 24 and 36 after the first dose of primary vaccination course.

Conditions

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Hepatitis B Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Twinrix Group

Healthy and non-healthy male or female subjects, aged 41 years or older, who received combined Twinrix™ (720/20) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule.

Group Type EXPERIMENTAL

TWINRIX™

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Engerix-B+Havrix Group

Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of Engerix™-B (20 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Havrix™ (1440 EL.U) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.

Group Type ACTIVE_COMPARATOR

Engerix™-B

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

HAVRIX™

Intervention Type BIOLOGICAL

Intramuscular injection, 2 doses

HB VAX PRO+Vaqta Group

Healthy and non-healthy male or female subjects, aged 41 years or older, who received separate administrations of HB VAX PRO™ (10 μg) vaccine, administered intramuscularly in the left deltoid region, according to a 0, 1 and 6 month schedule and Vaqta™ (50 IU) vaccine, administered intramuscularly in the right deltoid region, according to a 0 and 6 month schedule.

Group Type ACTIVE_COMPARATOR

HB VAX PRO™

Intervention Type BIOLOGICAL

Intramuscular injection, 3 doses

Vaqta™

Intervention Type BIOLOGICAL

Intramuscular injection, 2 doses

Interventions

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TWINRIX™

Intramuscular injection, 3 doses

Intervention Type BIOLOGICAL

Engerix™-B

Intramuscular injection, 3 doses

Intervention Type BIOLOGICAL

HAVRIX™

Intramuscular injection, 2 doses

Intervention Type BIOLOGICAL

HB VAX PRO™

Intramuscular injection, 3 doses

Intervention Type BIOLOGICAL

Vaqta™

Intramuscular injection, 2 doses

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* Healthy and non-healthy male or female aged 41 years or older at the time of the first vaccination.
* Written informed consent obtained from the subject.
* No serological signs of hepatitis A or B infection at screening.
* 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 product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* History of any hepatitis A or hepatitis B vaccination or infection, since the primary vaccination study 100382.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment. .
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions during the primary vaccination period.

Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Wilrijk, , Belgium

Site Status

GSK Investigational Site

Hradec Králové, , Czechia

Site Status

GSK Investigational Site

Finsterwalde, Brandenburg, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

Site Status

GSK Investigational Site

Geringswalde, Saxony, Germany

Site Status

GSK Investigational Site

Pirna, Saxony, Germany

Site Status

GSK Investigational Site

Bad Bramstedt, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Bad Segeberg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Elmshorn, Schleswig-Holstein, Germany

Site Status

Countries

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Belgium Czechia Germany

References

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Van der Wielen M, Van Damme P, Chlibek R, Smetana J, von Sonnenburg F. Hepatitis A/B vaccination of adults over 40 years old: comparison of three vaccine regimens and effect of influencing factors. Vaccine. 2006 Jun 29;24(26):5509-15. doi: 10.1016/j.vaccine.2006.04.016. Epub 2006 May 4.

Reference Type BACKGROUND

PMID: 16725234 (View on PubMed)

Study Documents

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Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 100382 are summarised with studies 100383, 100384, and 100385 on the GSK Clinical Study Register.

View Document