Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Primary Purpose
Hepatitis B, Hepatitis A
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Twinrix™ Adult
Twinrix™ Junior
Sponsored by
![GlaxoSmithKline](https://trials-media.s3.amazonaws.com/orgs/glaxosmithkline.jpeg)
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Combined hepatitis A and B vaccine, Twinrix™
Eligibility Criteria
Inclusion Criteria: Participation in primary study Written informed consent obtained before each long term follow up visit.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Twinrix Junior
Twinrix Adult
Arm Description
Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
Outcomes
Primary Outcome Measures
Anti-hepatitis A (HAV) Antibody Concentrations
Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
Anti-hepatitis B (HBs) Antibody Concentrations
Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.
Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).
Secondary Outcome Measures
Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.
A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.
Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events
A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00197184
Brief Title
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Official Title
Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 1, 2003 (undefined)
Primary Completion Date
March 10, 2004 (Actual)
Study Completion Date
March 10, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatitis A
Keywords
Combined hepatitis A and B vaccine, Twinrix™
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Twinrix Junior
Arm Type
Experimental
Arm Description
Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
Arm Title
Twinrix Adult
Arm Type
Active Comparator
Arm Description
Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
Intervention Type
Biological
Intervention Name(s)
Twinrix™ Adult
Other Intervention Name(s)
Combined hepatitis A and B vaccine
Intervention Description
Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
Intervention Type
Biological
Intervention Name(s)
Twinrix™ Junior
Other Intervention Name(s)
Combined hepatitis A and B vaccine
Intervention Description
Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
Primary Outcome Measure Information:
Title
Anti-hepatitis A (HAV) Antibody Concentrations
Description
Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
Time Frame
Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Title
Anti-hepatitis B (HBs) Antibody Concentrations
Description
Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
Time Frame
Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Title
Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
Description
Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.
Time Frame
Before and one month after additional vaccination
Title
Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
Description
Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).
Time Frame
Before and One month after additional vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.
Description
A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame
From last study visit of the primary study up to Year 5 long term follow-up
Title
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms
Description
Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.
Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful
Time Frame
during the 4-day follow-up period after additional vaccination
Title
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.
Description
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination
Time Frame
During the 4-day follow-up period after additional vaccination
Title
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).
Description
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time Frame
During the 30-day follow-up period after additional vaccination.
Title
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events
Description
A serious adverse event (SAE) is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame
At least one month after additional vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participation in primary study
Written informed consent obtained before each long term follow up visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
GSK Investigational Site
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08042
Country
Spain
Facility Name
GSK Investigational Site
City
Blanes (Girona)
ZIP/Postal Code
17300
Country
Spain
Facility Name
GSK Investigational Site
City
Cerdanyola Del Vallés / Barcelona
ZIP/Postal Code
08290
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46024
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
20434544
Citation
Marshall H, Nolan T, Diez Domingo J, Rombo L, Sokal EM, Mares J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years. Vaccine. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208127/132 (EXT Y2)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208127/132 (EXT Y2)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208127/132 (EXT Y2)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208127/132 (EXT Y2)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208127/132 (EXT Y2)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208127/132 (EXT Y2)
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 208127/132 are summarised with studies 208122/133, 208127/134 and 208127/137 on the GSK Clinical Study Register.
Learn more about this trial
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
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