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Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine

NCT04025580 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-01-02

Study results available
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Summary

Background:

Vaccines help prevent disease by causing the body to have an immune response. Many parts of this response happen in the blood. This response happens over days and weeks after getting the vaccine. Researchers want to how the blood changes over time in response to vaccines. They want to find out why vaccines work better for some people than for others. This could help make more effective vaccines.

Objective:

To learn about how the body responds to vaccines.

Eligibility:

Healthy people ages 18 and older

Design:

Participants will be screened with a medical history, physical exam, and blood and urine tests.

Participants will have 9 visits over 6 months. All visits will include blood tests and a physical exam.

Participants will have the first visit 1 week before they get the vaccine.

Participants will get the flu vaccine at the second visit. The vaccine will be injected into the muscle of the upper arm with a needle. They will be watched for side effects for 15 minutes.

Participants will have the next 2 visits exactly 1 day and 1 week after they get the vaccine. They will have the other 5 visits about 14, 28, 70, and 100 days after they get the vaccine.

Participants will take email questionnaires about whether they had any side effects.

Participants may have optional extra study visits. These will be no more than once a month for up to 1 year after they get the vaccine. Optionally, they can also repeat the study each year through the 2023 - 2024 flu season

Conditions

  • Healthy Volunteer

Interventions

BIOLOGICAL

Flucelvax

Seasonal influenza vaccine

BIOLOGICAL

Fluvirin

Seasonal influenza vaccine

BIOLOGICAL

Fluzone High Dose

Seasonal influenza vaccine for adults ages 65 and older

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Rachel D Sparks, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04025580 on ClinicalTrials.gov