Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination
Challenge Dose Administration of Twinrix™ or Comparator 4 Years After Primary Vaccination.
1 other identifier
interventional
506
2 countries
2
Brief Summary
Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2008
Shorter than P25 for phase_4
2 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
First Submitted
Initial submission to the registry
May 23, 2008
CompletedStudy Start
First participant enrolled
May 26, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2008
CompletedResults Posted
Study results publicly available
December 3, 2009
CompletedAugust 17, 2018
March 1, 2017
5 months
May 23, 2008
October 29, 2009
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis A (Anti-HAV) Antibodies
Anamnestic response was defined as: * for initially seronegative subjects, antibody concentration greater than or equal the cut-off \[≥ 15 Milli-International Units per Milliliter (mIU/mL)\], * for initially seropositive subjects with pre-vaccination antibody, concentration \< 100 mIU/mL: antibody concentration at least four times the pre-vaccination antibody concentration, * for initially seropositive subjects with pre-vaccination antibody concentration ≥ 100 mIU/mL: antibody concentration at least two times the pre-vaccination antibody concentration.
One month after the challenge dose.
Number of Subjects With Anamnestic Response to the Challenge Dose for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies
Anamnestic response was defined as : * for initially seronegative subjects, antibody concentration ≥ 10 Milli-International Units per Milliliter (mIU/mL), * for initially seropositive subjects: antibody concentration at ≥ 4 fold the pre-vaccination antibody concentration.
One month after the challenge dose.
Secondary Outcomes (6)
Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Prior to administration of challenge dose
Anti-hepatitis A (Anti-HAV) and Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations
Two weeks and one month after the challenge dose
Number of Subjects Reporting Solicited Symptoms
During the 4-day follow-up period after the challenge dose.
Number of Subjects Reporting Unsolicited Symptoms
During the 31-day follow-up period after the challenge dose.
Number of Subjects With Serious Adverse Events (SAEs) Since the Last Study Visit of the HAB-160 (NCT00603252) Long-term Follow-up Study Considered by the Investigator to Have a Causal Relationship to Primary Vaccination
Since the last study visit of the primary study long-term follow-up study up to challenge dose administration (1 year)
- +1 more secondary outcomes
Study Arms (3)
Twinrix Group
EXPERIMENTALSubjects received a single challenge dose of combined hepatitis A/hepatitis B vaccine (Twinrix).
Engerix + Havrix Group
ACTIVE COMPARATORSubjects received separate administration of a single challenge dose of hepatitis B vaccine (Engerix) and hepatitis A vaccine (Havrix).
HB VAX PRO + Vaqta Group
ACTIVE COMPARATORSubjects received separate administration of a single challenge dose of hepatitis B vaccine (HB VAX PRO) and hepatitis A vaccine (Vaqta).
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 HAB-160 study (NCT 00603252).
- 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 the vaccination.
You may not qualify if:
- The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, 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 (2)
GSK Investigational Site
Wilrijk, 2610, Belgium
GSK Investigational Site
Hradec Králové, 500 01, Czechia
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)
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
May 23, 2008
First Posted
May 28, 2008
Study Start
May 26, 2008
Primary Completion
November 3, 2008
Study Completion
November 3, 2008
Last Updated
August 17, 2018
Results First Posted
December 3, 2009
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.