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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: Completed Phase 4 study of COVID-19 and Corona Virus Infection, sponsored by University of Michigan.
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 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Results reflect the number of participants who had previously received the Pfizer-BioNTech, the Moderna mRNA COVID-19 vaccine, or both, and who had experienced an adverse reaction (AR). An AR would be any symptom reported or objective finding during the 30-minute observation, or any symptom reported at the 7 day follow up. ARs were graded using the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, which ut
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 |
What the finished NCT05212610 record still lists
NCT05212610 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05212610's enrollment target sits among peer trials
103 197th of 298 higher than 101 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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