CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 98 enrolled
Drug / intervention
Flucelvax +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04025580
NCT04025580Phase 2Completed

Systems Analyses of the Immune Response to the Seasonal Influenza Vaccine

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 19, 2019·Updated Jan 2, 2024

In Brief

A Phase 2 clinical trial evaluating Flucelvax, Fluvirin, and 1 other intervention for Healthy Volunteer. Completed, enrolled 98 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 19, 2019
Enrollment StartOct 2, 2019
Primary CompletionJan 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.0 years ago

Interventions

Flucelvaxbiological

Seasonal influenza vaccine

Fluvirinbiological

Seasonal influenza vaccine

Fluzone High Dosebiological

Seasonal influenza vaccine for adults ages 65 and older