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Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Hepatitis B

Hepatitis A

Eligibility:

All Genders

41+ years

Phase:

PHASE4

Brief Summary

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 Biolog...

Detailed 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.

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 24 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 21 2004

    Estimated Enrollment :

    596 Patients enrolled

    Trial Details

    Trial ID

    NCT00289731

    Start Date

    November 24 2003

    End Date

    December 21 2004

    Last Update

    November 15 2019

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    GSK Investigational Site

    Wilrijk, Belgium, 2610

    2

    GSK Investigational Site

    Hradec Králové, Czechia, 500 01

    3

    GSK Investigational Site

    Finsterwalde, Brandenburg, Germany, 03238

    4

    GSK Investigational Site

    Dresden, Saxony, Germany, 01129