Last updated: 11/03/2018 11:04:44
A Phase III, Open-Label, Single-Dose Study to Evaluate the Safety and Immunogenicity of Fluviral® Vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
To evaluate the immunogenicity of Fluviral influenza vaccine in adults 18 years or older
Timeframe: 21 days after vaccination
Secondary outcomes:
Evaluate safety & reactogenicity: Solicited AEs
Timeframe: 4 days
Evaluate safety & reactogenicity: Unsolicited AEs
Timeframe: 21 days
Evaluate safety & reactogenicity: SAEs
Timeframe: entire study
Interventions:
Biological/vaccine: Fluviral®
Enrollment:
110
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK1536489A
Collaborators
Not applicable
Study date(s)
July 2007 to August 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- Healthy male and female adults, 18 years of age and older.
- Female subject of non-childbearing potential.
- Acute disease at the time of enrollment.
- Blood pressure abnormalities.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-20-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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