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NCT05212610 · ClinicalTrials.gov registry record · Phase 4
Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
A Phase 4 study of COVID-19 and Corona Virus Infection, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 103
- Enrollment target
- 1
- Study location
NCT05212610 is a Phase 4 study of COVID-19 and Corona Virus Infection that has completed, run by University of Michigan. The registered enrollment target is 103 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05212610, a Phase 4 study of COVID-19 and Corona Virus Infection, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 103 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection ("long COVID"). Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits. We hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated. The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
Conditions Studied
Interventions
- BIOLOGICAL Pfizer-BioNTech mRNA COVID-19 vaccine
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2022-03-21 |
| Est. Completion | 2025-03-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05212610
The ClinicalTrials.gov registry entry for NCT05212610 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which Pfizer-BioNTech mRNA COVID-19 vaccine is the first listed.
NCT05212610 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT05212610 about?
NCT05212610 is a clinical study titled "Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction". This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal h...
What is the current status of trial NCT05212610?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2022-03-21. Estimated completion is 2025-03-07.
What conditions does trial NCT05212610 study?
This clinical trial studies the following conditions: COVID-19, Corona Virus Infection.
What interventions are being tested in trial NCT05212610?
The interventions under investigation include: Pfizer-BioNTech mRNA COVID-19 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05212610?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05212610 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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