NCT02200276 Influenza Immunization in Adults Over Age 75
| NCT ID | NCT02200276 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Influenza |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,025 participants |
| Start Date | 2014-03 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,025 participants in total. It began in 2014-03 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The immune system is the part of the body that protects against infection. The immune system often doesn't work as effectively as people get older. This research is being done to find out how the immune systems in older people who are over age 75 respond to influenza vaccine (flu shot). We also want to find out if chronic cytomegalovirus (CMV) infection, a common virus infection in older persons affects the immune response in people older than 75 years of age who receive a flu shot. The Flu Shot is a vaccine approved for the prevention of influenza ("Flu") infections and is recommended every year for all persons 50 years and older. People who are older than 75 years of age are considered healthy or frail may join. A total of 1025 persons will be participating in this study. In order to determine if you are qualified for the study, we would ask you to answer a few questions over the phone that will take approximately 5 minutes. If you qualify and agree to proceed, you will be asked to come to Johns Hopkins Bayview Medical Center or, if you are unable to come to Bayview, one of our staff can visit you at your home. During that visit we obtain consent, review your medical history, and measure your vital signs, walking speed and grip strength. We will also administer a few brief questionnaires and collect urine and blood samples. We will then give you the Influenza vaccine for free. 7 days post receiving your Influenza Vaccine we will collect a small blood sample for further immune system testing. also, you will be asked to complete a 12-question survey which will assess your symptoms over the past 7 days (post receiving the Influenza vaccine). Also 4 weeks post receiving your Influenza vaccine you will be asked to complete a third visit that will include follow up health questionnaires and an influenza symptoms assessment questionnaire and vital signs. A third blood draw will be collected (approximately 10 teaspoons) to measure immune responses to the influenza vaccine. In addition, you will receive your test result (CBC/w/Diff.) from visit #1. Throughout the influenza study season, we will call you once a week to ask about your general health and any Flu-like symptoms. These calls will be made throughout the Flu season which typically lasts through May. If you begin to have any influenza like symptoms at any time during the study, we ask that you call our office to report these symptoms so that we may perform vital signs, nasal swab to confirm influenza, and a fourth blood draw to look at the immune response and protection of influenza vaccine.
Eligibility Criteria
Inclusion Criteria: * Adults over age 75 years Exclusion Criteria: * Allergies to egg or vaccine * Active malignancies * On radiation or chemotherapy * Active systemic inflammatory diseases including rheumatoid arthritis, Crohn's disease, and ulcerative colitis * Acute exacerbation of chronic cardiopulmonary conditions including decompensated CHF or COPD * Taking oral steroids (such as prednisone) or immune modulating drugs (such as methotrexate). * Lacking the capacity to consent (individuals who do not understand what Flu shot is or need someone else to decide if s/he should get the Flu shot)
Contact & Investigator
Sean Leng
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT02200276 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Influenza. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02200276 currently recruiting?
Yes, NCT02200276 is actively recruiting participants. Contact the research team at tagboka1@jhmi.edu for enrollment information.
Where is the NCT02200276 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT02200276 clinical trial?
NCT02200276 is sponsored by Johns Hopkins University. The principal investigator is Sean Leng at Johns Hopkins University. The trial plans to enroll 1,025 participants.