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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Hepatitis A; Hepatitis B

Treatments: Biological: HAVRIX™; Biological: Vaqta™; Biological: Engerix™-B; Biological: HB VAX PRO™; Biological: TWINRIX™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289731

100382

100385 (Other Identifier)

100384 (Other Identifier)

100383 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 596 patients

Sex: All

Ages: 41+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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596 participants in 3 patient groups

Twinrix Group

Experimental group

Description:

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.

Treatment:

Biological: TWINRIX™

Engerix-B+Havrix Group

Active Comparator group

Description:

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.

Treatment:

Biological: Engerix™-B

Biological: HAVRIX™

HB VAX PRO+Vaqta Group

Active Comparator group

Description:

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.

Treatment:

Biological: Vaqta™

Biological: HB VAX PRO™