Understanding Immunity to the Flu Vaccine in COVID-19 Pat... | NCT04579588

Studies
Understanding Immunity to the Flu Vaccine in COVID-19 Patients

NCT04579588

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

230Estimated

Phase

Not provided

Conditions

Corona Virus Infection
Flu Vaccine
Immunity

Interventions

Flu shot

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5U19AI057229-17	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2020Actual

Primary Completion Date

Apr 2028Estimated

Completion Date

Apr 2028Estimated

First Submitted Date

Oct 6, 2020

First Submission Date that Met QC Criteria

Oct 6, 2020

First Posted Date

Oct 8, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sayantani B. Sindher, Associate Professor of Medicine, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

230Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 participants			Biological: Flu shot
Control participants			Biological: Flu shot

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flu shot	Biological	All participants will receive a single shot of the flu vaccine	COVID-19 participants Control participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Testing immunity to the flu vaccine over time		1 week
Testing immunity to the flu vaccine over time		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

64 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SNP Center Inquiry	Contact	(650) 521-7237		snpcenterallergy_inquiry@stanford.edu

Overall Officials

Name	Affiliation	Role
Sayantani Sindher, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Palo Alto	California	94304	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections
D007251	Influenza, Human

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007252	Influenza Vaccines

Ancestor Terms

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

Browse Leaves

Not provided

Browse Branches

Not provided