Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)
NCT ID: NCT01424371
Last Updated: 2012-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1000 participants
OBSERVATIONAL
2011-11-30
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adjuvanted Vaccine Group
No interventions assigned to this group
Unadjuvanted Vaccine Group
No interventions assigned to this group
Unvaccinated Elderly
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Cases: Proven influenza diagnosed on naso-pharyngeal swab via PCR Controls: Elderly with influenza-like-illness testing negative for influenza during the influenza season.
Exclusion Criteria
2. Current or recent (within 90 days prior to first dose of influenza vaccine) immunosuppressive treatment including chronic oral steroids (1mg/kg for \> 4 weeks), cytotoxic chemotherapy, radiation therapy, other immunosuppressive drug and biologic agents Note: Use of topical or inhalant corticosteroids is acceptable.
3. Administration of immunoglobulins during the study period;
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Fraser Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paul VanBuynder
Chief Medical Health Officer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
PAUL G VAN BUYNDER, MBBS MPH
Role: PRINCIPAL_INVESTIGATOR
Fraser Health Authority
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fraser Health Authority
Surrey, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-071
Identifier Type: -
Identifier Source: org_study_id