Last updated: 06/13/2019 12:30:16
A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New versus Aged Bulk
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age from 18 to 60 Years
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 World Health Organization (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. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Geometric Mean Titers (GMTs) of anti-H3 and B strains
Timeframe: At Day 21
Secondary outcomes:
Geometric mean titers (GMTs) of the H1 strain and the GMT of the H3 and B strains
Timeframe: At Days 0 and 21
Number of participants who seroconverted.
Timeframe: At Day 21.
Number of seroprotected participants.
Timeframe: At Days 0 and 21
Seroconversion Factors defined as the fold increase in serum HI GMTs post-vaccination for influenza antigen H1N1
Timeframe: At Day 21 compared to Day 0
The fold increase in anti-HI GMTs for influenza antigens H3 and B
Timeframe: At Day 21 compared to Day 0
Number of participants reporting solicited local symptoms
Timeframe: During the 4-day follow up period following vaccination.
Number of participants reporting solicited general symptoms
Timeframe: During the 4-day period following each vaccination.
Number of participants reporting unsolicited adverse events (AE).
Timeframe: During the 21-day period following each vaccination.
Number of participants reporting serious adverse events (SAE)
Timeframe: Within 21 days after vaccination
Interventions:
Biological/vaccine: Fluviral
Enrollment:
1000
Observational study model:
Not applicable
Primary completion date:
2008-14-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza Vaccines
Product
GSK1536489A
Collaborators
Not applicable
Study date(s)
December 2007 to January 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 60 years
Accepts healthy volunteers
Yes
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Male and female adults, 18 to 60 years.
- Acute disease at the time of enrollment.
- Any confirmed or suspected immunosuppressive condition
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Male and female adults, 18 to 60 years.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
Exclusion criteria:
- Acute disease at the time of enrollment.
- Any confirmed or suspected immunosuppressive condition
- Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- A history of any demyelinating disease including Guillain-Barré syndrome.
- Presence of an active neurological disorder.
- Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
- Receipt of an influenza vaccine within 6 months prior to study enrollment.
- Administration of any vaccines within 30 days prior to study enrollment or during the study period.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
- A history of severe adverse reaction to a previous influenza vaccination.
- Lactating/nursing female.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Trial location(s)
Location
GSK Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Status
Study Complete
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-14-01
Actual study completion date
2008-14-01
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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