Study to Show That the Combined Hepatitis A and B Vaccine is Non-inferior to Monovalent Vaccines in Adults
Evaluate the Effect of Risk Factors That Influence the Immunogenicity of GSK Biologicals' Twinrix Compared to Hepatitis A and Hepatitis B Vaccines Given Separately and to Show the Non-inferiority Between the Vaccines in Adults
1 other identifier
interventional
213
2 countries
8
Brief Summary
This protocol posting describes the booster phase of the study. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2008
Shorter than P25 for phase_4
8 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
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 16, 2008
CompletedFirst Posted
Study publicly available on registry
January 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedMarch 14, 2017
March 1, 2017
5 months
January 16, 2008
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Anti-HAV immune response to the challenge dose
Anti-HBs antibody response to the challenge dose
Secondary Outcomes (6)
Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects
Two weeks and one month after the challenge dose
Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects
Two weeks and one month after the challenge dose
Occurrence and intensity of solicited local symptoms
In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship of solicited general symptoms
In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported
During the 31-day follow-up period after the challenge dose
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- A male or female who completed the primary vaccination phase of the study.
- Written informed consent obtained from the subject.
- 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 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (8)
GSK Investigational Site
Wilrijk, 2610, Belgium
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)
Chlibek R, von Sonnenburg F, Van Damme P, Smetana J, Tichy P, Gunapalaiah B, Leyssen M, Jacquet JM. Antibody persistence and immune memory 4 years post-vaccination with combined hepatitis A and B vaccine in adults aged over 40 years. J Travel Med. 2011 Mar-Apr;18(2):145-8. doi: 10.1111/j.1708-8305.2010.00499.x. Epub 2011 Feb 7.
PMID: 21366801DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
January 16, 2008
First Posted
January 29, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
March 14, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.