Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc
Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals' Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines
4 other identifiers
interventional
596
3 countries
9
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2003
Shorter than P25 for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 24, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2004
CompletedFirst Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedResults Posted
Study results publicly available
October 3, 2018
CompletedNovember 15, 2019
October 1, 2019
1.1 years
February 9, 2006
January 30, 2017
October 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Antibody Concentrations for Anti-hepatitis A Virus (Anti-HAV) and Anti-hepatitis B Surface (Anti-HBs) Antigens
Anti-HAV and anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL). The reference seropositivity cut-off values for anti-HAV and anti-HBs antibodies were equal to or above (≥) 15 mIU/mL and ≥ 3.3 mIU/mL, respectively.
At Month 7 after Twinrix vaccination
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value
Seropositivity for anti-HAV antibodies was defined as anti-HAV antibody concentration ≥ 15mIU/mL; seropositivity for anti-HBs antibodies was defined as anti-HBs antibody concentration ≥ 3.3 mIU/mL.
At Month 7
Number of Seroprotected Subjects Against Hepatitis B Surface (HBs) Antigen
A seroprotected subject was defined as a vaccinated subject with a serum anti-HBs antibody concentration equal to or above (≥) 10 mIU/mL.
At Month 7
Secondary Outcomes (27)
Anti-HAV and Anti-HBs Antibody Concentrations
At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Gender
At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Age
At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Body Mass Index (BMI)
At Month 7
Number of Subjects With Anti-HAV and Anti-HBs Antibody Concentrations Above the Cut-off Value, by Smoking Status
At Month 7
- +22 more secondary outcomes
Study Arms (3)
Twinrix Group
EXPERIMENTALHealthy 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.
Engerix-B+Havrix Group
ACTIVE COMPARATORHealthy 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.
HB VAX PRO+Vaqta Group
ACTIVE COMPARATORHealthy 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (9)
GSK Investigational Site
Wilrijk, 2610, Belgium
GSK Investigational Site
Hradec Králové, 500 01, Czechia
GSK Investigational Site
Finsterwalde, Brandenburg, 03238, Germany
GSK Investigational Site
Dresden, Saxony, 01129, Germany
GSK Investigational Site
Geringswalde, Saxony, 09326, Germany
GSK Investigational Site
Pirna, Saxony, 01796, Germany
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, 24576, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795, Germany
GSK Investigational Site
Elmshorn, Schleswig-Holstein, 25335, Germany
Related Publications (1)
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.
PMID: 16725234BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 10, 2006
Study Start
November 24, 2003
Primary Completion
December 21, 2004
Study Completion
December 21, 2004
Last Updated
November 15, 2019
Results First Posted
October 3, 2018
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.