Back to resultsComparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hepatitis B adjuvanted vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- A male or female > = 15 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject/ from the parents or guardians of the subject.
- Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).
- If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
- Pre-haemodialysis patient* or a patient on haemodialysis.
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
- Previous vaccination against hepatitis B.
- History of hepatitis B infection.
- Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
- Clinically abnormal ALT/AST values (> 3 times normal values)
Sites / Locations
Outcomes
Primary Outcome Measures
Anti-HBs seroprotection rates at Month 7.
Secondary Outcome Measures
Solicited symptoms, unsolicited symptoms and serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00383227
Brief Title
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
Official Title
A Phase III, Clinical Trial Comparing the Immunogenicity and Safety of SmithKline Beecham Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-haemodialysis/Haemodialysis Patients (>=15 Years of Age)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
November 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Hepatitis B adjuvanted vaccine
Primary Outcome Measure Information:
Title
Anti-HBs seroprotection rates at Month 7.
Secondary Outcome Measure Information:
Title
Solicited symptoms, unsolicited symptoms and serious adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A male or female > = 15 years of age at the time of the first vaccination.
Written informed consent obtained from the subject/ from the parents or guardians of the subject.
Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).
If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
Pre-haemodialysis patient* or a patient on haemodialysis.
Exclusion Criteria:
Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
Previous vaccination against hepatitis B.
History of hepatitis B infection.
Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
Clinically abnormal ALT/AST values (> 3 times normal values)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
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
18160963
Citation
Kong NC, Beran J, Kee SA, Miguel JL, Sanchez C, Bayas JM, Vilella A, Calbo-Torrecillas F, Lopez de Novales E, Srinivasa K, Stoffel M, Hoet B. A new adjuvant improves the immune response to hepatitis B vaccine in hemodialysis patients. Kidney Int. 2008 Apr;73(7):856-62. doi: 10.1038/sj.ki.5002725. Epub 2007 Dec 26.
Results Reference
background
PubMed Identifier
16221232
Citation
Tong NK, Beran J, Kee SA, Miguel JL, Sanchez C, Bayas JM, Vilella A, de Juanes JR, Arrazola P, Calbo-Torrecillas F, de Novales EL, Hamtiaux V, Lievens M, Stoffel M. Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney Int. 2005 Nov;68(5):2298-303. doi: 10.1111/j.1523-1755.2005.00689.x.
Results Reference
background
PubMed Identifier
18845199
Citation
Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
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
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/032
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
208129/032
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/032
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
208129/032
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
208129/032
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
208129/032
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years
We'll reach out to this number within 24 hrs