A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Fluviral®
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza
Eligibility Criteria
Inclusion Criteria:
- Healthy male and female adults, 18 years of age and older.
- Female subject of non-childbearing potential. Written informed consent obtained from subject.
Exclusion Criteria:
- Acute disease at the time of enrollment.
- Blood pressure abnormalities.
- Any immunosuppressive condition, such as HIV or cancer.
- Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus.
- Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
- Any demyelinating disease, including Guillain-Barré syndrome.
- Alcohol consumption and/or drug abuse.
- Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment.
- Any known or suspected allergy to the Fluviral vaccine.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older
Secondary Outcome Measures
Evaluate safety & reactogenicity: Solicited AEs
Evaluate safety & reactogenicity: Unsolicited AEs
Evaluate safety & reactogenicity: SAEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00505453
Brief Title
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine
Official Title
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) in Adults Ranging in Age From 18 to 60 Years and 61 Years and Over
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of WHO experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season.
This study is designed to test the safety/reactogenicity and the immunogenicity of the Fluviral Trivalent Split Virion Influenza Vaccine containing the influenza strains recommended for the 2007-2008 season.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Fluviral®
Primary Outcome Measure Information:
Title
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older
Time Frame
21 days after vaccination
Secondary Outcome Measure Information:
Title
Evaluate safety & reactogenicity: Solicited AEs
Time Frame
4 days
Title
Evaluate safety & reactogenicity: Unsolicited AEs
Time Frame
21 days
Title
Evaluate safety & reactogenicity: SAEs
Time Frame
entire study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male and female adults, 18 years of age and older.
Female subject of non-childbearing potential. Written informed consent obtained from subject.
Exclusion Criteria:
Acute disease at the time of enrollment.
Blood pressure abnormalities.
Any immunosuppressive condition, such as HIV or cancer.
Renal impairment, hepatic dysfunction, complicated insulin-dependent diabetes mellitus.
Unstable cardiopulmonary disease requiring chronic medical therapy or associated with functional impairment.
Any demyelinating disease, including Guillain-Barré syndrome.
Alcohol consumption and/or drug abuse.
Receipt of an influenza vaccine within 9 months prior to enrollment or of any vaccines within 30 days prior to enrollment.
Any known or suspected allergy to the Fluviral vaccine.
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
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
Facility Name
GSK Investigational Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
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.
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110502
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
110502
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
110502
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
110502
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
110502
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
110502
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
110502
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine
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