Corona Virus InfectionNCT04579588
Understanding Immunity to the Flu Vaccine in COVID-19 Patients
An observational study of Corona Virus Infection and Flu Vaccine, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Read more about this study
- Who is it for?
- Ages 9 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection, Flu Vaccine, Immunity
- What is being tested?
- Flu shot
- Type of treatment
- Vaccines
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adults (18-64 years) and children (9-17 years) diagnosed and not diagnosed (controls) with COVID-19 and who may have other medical conditions including long term COVID-19 symptoms, chronic fatigue, type 2 diabetes, and obesity.
Who may be able to join
- Age 9 through 64 years
- Diagnosed with COVID-19 at least 2 months prior enrollment
- Patients with or without obesity, diabetes, chronic fatigue and/or long term COVID-19 symptoms
- Patients without COVID-19 diagnosis for controls
Who cannot join
- Received the influenza vaccine less than 4 months ago
- Pregnant or lactating
- Patients with special risks attendant to venipuncture
- Use of immunomodulatory medications that may impact vaccine immune response per clinician's judgment
- Contraindication to the flu vaccine
- Immunodeficiency or autoimmune disease that may impact vaccine immune responses per clinician's judgement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
SNP Center Inquiry, (650) 521-7237, snpcenterallergy_inquiry@stanford.edu
About this study
The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 9 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.
- Conditions
- Corona Virus Infection, Flu Vaccine, Immunity
- Being tested
- Flu shot
- Medical subject headings
- Coronavirus Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flu shotBiological
All participants will receive a single shot of the flu vaccine
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 participants | Not described Receives: Biological: Flu shot | |
| Control participants | Not described Receives: Biological: Flu shot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing immunity to the flu vaccine over time
Measured: 1 week
Testing immunity to the flu vaccine over time
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start29 Oct 2020
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayantani B. Sindher, Stanford University
- Investigators
- Sayantani Sindher, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579588
- Sponsor's protocol ID
- IRB-58356
- Other IDs
- 5U19AI057229-17
- Status last verified
- Nov 2025
- First submitted
- 6 Oct 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No