Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children
5 other identifiers
interventional
178
1 country
1
Brief Summary
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. This protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10. 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 P25-P50 for phase_3
Started Feb 2004
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2004
CompletedFirst Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2009
CompletedResults Posted
Study results publicly available
August 26, 2010
CompletedAugust 20, 2018
July 1, 2018
5.2 years
February 9, 2006
April 8, 2010
July 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Years 6, 7, 8, 9, and 10.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
At Year 6, 7, 8, 9 and 10
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Before and 1 month after the additional dose administration
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
Immune response was defined as: * anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points * at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.
One month after the additional dose administration
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
At Year 6, 7, 8, 9 and 10
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
During the 4-day follow-up period after additional dose
Number of Subjects Reporting Unsolicited Adverse Events
Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
During the 30-day follow-up period after additional dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
During the 30-day follow-up period after additional dose
Study Arms (3)
Twinrix Group
EXPERIMENTALSubjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076)
Engerix-B Additional Dose (Adult)
EXPERIMENTALSubjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose).
Engerix-B Additional Dose (Pediatric)
EXPERIMENTALSubjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose).
Interventions
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
Eligibility Criteria
You may qualify if:
- Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
- Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Wilrijk, 2610, Belgium
MeSH Terms
Conditions
Condition 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 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 10, 2006
Study Start
February 16, 2004
Primary Completion
April 15, 2009
Study Completion
April 15, 2009
Last Updated
August 20, 2018
Results First Posted
August 26, 2010
Record last verified: 2018-07