Back to resultsImmuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Engerix™-B (thiomersal-free) 20µg
10 μg Engerix™-B (preservative-free)
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Persistence, Hepatitis B vaccine
Eligibility Criteria
Inclusion Criteria: Subjects have participated in primary study HBV-280 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
Sites / Locations
- 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
2-Dose Engerix
3-Dose Engerix
Arm Description
subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Outcomes
Primary Outcome Measures
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Antibody Titers Against Hepatitis-B Virus.
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Secondary Outcome Measures
Antibody Titers Against Hepatitis-B Virus.
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Number of Subjects Seroprotected for Anti-HBs Antibody.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).
An unsolicited AE covers 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 With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects With Serious Adverse Events (SAEs).
erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00343915
Brief Title
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Official Title
Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 21, 2004 (Actual)
Primary Completion Date
January 10, 2008 (Actual)
Study Completion Date
January 10, 2008 (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 antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.
Subjects were aged 11 to 15 years at the time of the primary vaccination course.
At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.
No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Persistence, Hepatitis B vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
267 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-Dose Engerix
Arm Type
Experimental
Arm Description
subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Arm Title
3-Dose Engerix
Arm Type
Active Comparator
Arm Description
subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Intervention Type
Biological
Intervention Name(s)
Engerix™-B (thiomersal-free) 20µg
Intervention Description
In the primary study: 2 deep intramuscular injections (Months 0, & 6)
Intervention Type
Biological
Intervention Name(s)
10 μg Engerix™-B (preservative-free)
Intervention Description
In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
In the primary study: 1 deep intramuscular injection (month 1)
Primary Outcome Measure Information:
Title
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
Description
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame
At Month 7
Title
Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody.
Description
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame
At Month 30, Month 42, Month 54 and Month 66
Title
Antibody Titers Against Hepatitis-B Virus.
Description
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Time Frame
At Month 30, Month 42, Month 54 and Month 66
Secondary Outcome Measure Information:
Title
Antibody Titers Against Hepatitis-B Virus.
Description
Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Time Frame
At Months 1, 2, 6 and 7
Title
Number of Subjects Seroprotected for Anti-HBs Antibody.
Description
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame
At Months 1, 2 and 6
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame
During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Description
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
Time Frame
During the 4-day (Day 0-3) follow-up period after each vaccination and overall
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE).
Description
An unsolicited AE covers 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 31-day (Day 0-30) follow-up period after each vaccination and overall
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
During the entire study period (Month 0 to Month 66)
Title
Number of Subjects With Serious Adverse Events (SAEs).
Description
erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
At Month 30, Month 42, Month 54 & Month 66
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects have participated in primary study HBV-280
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
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
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
03038
Country
Ukraine
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
17276552
Citation
Heron L, Selnikova O, Moiseieva A, Van Damme P, van der Wielen M, Levie K, Hoet B, Stoffel M. Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial. Vaccine. 2007 Apr 12;25(15):2817-22. doi: 10.1016/j.vaccine.2006.12.021. Epub 2006 Dec 29.
Results Reference
background
PubMed Identifier
12297392
Citation
Heron LG, Chant KG, Jalaludin BB. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine. 2002 Oct 4;20(29-30):3472-6. doi: 10.1016/s0264-410x(02)00346-8.
Results Reference
background
PubMed Identifier
21171982
Citation
Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357.
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101695 Ext. Mth30
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
101695 Ext. Mth30
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
101695 Ext. Mth30
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
101695 Ext. Mth30
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 101695 (Ext HBV-280 M30) are summarised with studies 103860/280 (HBV-280), 101696 (Ext HBV-280 M42), 101697 (Ext HBV-280 M54) and 101698
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
101695 Ext. Mth30
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
We'll reach out to this number within 24 hrs