Effectiveness of Influenza Vaccines in Preventing Pandemic Influenza Virus Infection Among Healthcare Personnel, First Responders, and School Personnel
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-005159
Sponsor Protocol Number: 15-005159
About this study
The purpose of this study is to assess influenza vaccine effectiveness (VE) in preventing pandemic influenza virus illness and infection, and to assess the incidence of pandemic influenza virus infection and illness among Health care providers (HCP), first responders (FR) (police, fire, and Emergency Medical Technicians [EMT]) and school personnel (SP).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥18 years.
- Direct face to face contact, within 3 feet, with patients, students, or public as part of full-time (>30 hours/week) job responsibilities.
- K-12 SP with daily face-to-face contact with students throughout the school year.
- Access to medical records:
- For participants recruited through study sites: HCP, FR and SP who currently and for a minimum of 12 months prior to enrollment receive their medical care through the study site institution as their medical home (either membership in site institution medical plan or part of long-term epidemiologic cohort where medical history and ongoing medical encounter data are captured consistently), and who plan to remain in the area and medical home for the next 12 months (study duration period).
- For participants recruited through local, regional and national organizations: Willingness to grant access to prior 5 years and current medical records to research staff and ability to access or receive medical records remotely.
- Access to the internet and a phone with text messaging capabilities.
- Willingness to complete twice-weekly symptom assessments via email, phone application or text messaging.
- Willingness to be contacted periodically by study staff via email and telephone.
- Willingness to collect respiratory specimens with nasal swabs when prompted and to package and ship specimens using express mail promptly.
- Willingness to provide blood and serum samples at study enrollment, and again after vaccination and laboratory-confirmed influenza infection/illness, if applicable.
Exclusion Criteria:
- Work less than an average of 30 hours per week.
- Inability to speak or understand English.
- Unwilling to provide verbal and electronic confirmation of consent.
- The individual has previously requested that s/he not be contacted regarding research studies.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Robert Jacobson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available