Flu vaccine study aims to unlock Age-Related immune secrets
NCT ID NCT04101838
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how four different FDA-approved flu vaccines affect the immune system in 50 adults aged 18-50 and 65-80. Researchers will measure antibody levels and memory B cells to see how age and past vaccination history influence the body's response. The goal is to understand why older adults often have weaker flu protection and how to improve future vaccines.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inactivated seasonal influenza vaccines (Fluzone, Flucelvax, Fluzone High-Dose, Fluad)
- What this could lead to
- If successful, this study could help design better flu vaccines tailored to different age groups, potentially improving protection for older adults.
- What could go wrong
- This is an observational study of immune responses, not a test of new treatments. Results may not lead to immediate changes in vaccine recommendations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2021
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participation in ancillary clinical research study * Able to give informed consent * Age 18-50 years old for Arm 1 and Arm 2 * Age 65-80 years old for Arm 3, Arm 4, and Arm 5 * Weight of at least 110 lbs as determined by self-reporting Exclusion Criteria: * Inability to give informed consent * Refusal or inability to have blood drawn or participate in study procedures * Previous adverse reaction to influenza vaccine or medical history contraindicated for receiving influenza vaccine, including but not limited to: 1. History of Guillain-Barre Syndrome 2. History of egg allergy 3. History of gelatin allergy 4. History of moderate to severe illness with or without fever within 6 weeks of receipt of influenza vaccine * Previous receipt of influenza vaccine outside of study within current season * Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) * Participant has any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgement of the investigator would interfere with, or serve as a contraindication to the planned procedure(s). * These following criteria are used for scientific reasons, and not safety reasons. Specifically, the criteria are used to obtain a population that is healthy and less likely to have conditions that may influence the immune system: 1. No recent respiratory infections in the past 4 weeks at time of vaccination 2. Malignancy 3. Evidence of Inflammation: Systemic Lupus Erythematosis, Rheumatoid Arthritis, Polymyositis, Dermatomyositis, Scleroderma, Crohn's Disease, Ulcerative Colitis. 4. Lymphoproliferative Disorder 5. Known Immunodeficiency 6. Myocardial Infarction \<6 months 7. Cerebral Vascular Accident 8. Peripheral Vascular Disease- recannulation \<6months 9. Cardiac Insufficiency - congestive heart failure 10. Hypertension with increased blood urea nitrogen (BUN) 11. Renal Failure 12. Dementia 13. Alcoholism (defined as \>17 drinks/week) 14. Drug Abuse (excluding marijuana) 15. HIV positive 16. History of hepatitis 17. History of immunization within 4 weeks of study participation or plan to receive non- IIV vaccination within 4 weeks of receiving IIV 18. Moderate to severe illness at time of enrollment * Donations of blood in the 8 weeks prior to enrollment which, combined with expected volumes to be drawn for this study, would exceed 450 mL in an 8 week period. * Current pregnancy at time of enrollment or pregnancy within last 4 months * Active or planned breastfeeding during study participation * Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Influenza are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- When the immune system Can't fight back: tracking three respiratory viruses
- Flu's journey: scientists track how influenza passes between people
- Can a stronger flu shot boost immunity in older adults?
- A nudge in the mailbox: could a letter boost flu shots for millions at risk?
- Can a new pill shorten the flu?
- Can a texted story boost flu shots for black kids?