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NCT03996538 · ClinicalTrials.gov registry record · Phase 1
Vaccination Efficacy With Metformin in Older Adults
A Phase 1 study, sponsored by UConn Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03996538 is a Phase 1 study that has completed, run by UConn Health. The registered enrollment target is 26 participants.
The verdict
NCT03996538, a Phase 1 study, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
With aging the immune system gets weaker. This makes older adults more susceptible to influenza (flu). Vaccinations help to prevent infection from the flu virus, however the immune system of older adults do not respond as well to vaccines compared to young adults and thus, aren't as well protected from the complications from the flu. This research is being done to determine if Metformin, an FDA-approved diabetes medication, is effective at enhancing immune responses to flu vaccine in older men and women. Participants will be randomly assigned to either metformin or placebo treatment for a total of 22 weeks. Participants will be vaccinated with high-dose flu vaccine after 12 weeks of treatment. Immune responses will be evaluated throughout the study at 6 time points.
Interventions
- BIOLOGICAL Influenza Vaccine
- DRUG Metformin Hydrochloride Extended-Release Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2020-02-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03996538
The ClinicalTrials.gov registry entry for NCT03996538 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UConn Health, which has 178 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Influenza Vaccine is the first listed.
NCT03996538 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03996538 about?
NCT03996538 is a clinical study titled "Vaccination Efficacy With Metformin in Older Adults". With aging the immune system gets weaker. This makes older adults more susceptible to influenza (flu). Vaccinations help to prevent infection from the flu virus, however the immune system of older adults do not respond as well to vaccines compared to young adults and thus, aren't as well protected f...
What is the current status of trial NCT03996538?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-06-05. Estimated completion is 2020-02-04.
What interventions are being tested in trial NCT03996538?
The interventions under investigation include: Influenza Vaccine (BIOLOGICAL), Metformin Hydrochloride Extended-Release Tablets (DRUG).
Who is sponsoring clinical trial NCT03996538?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
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