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mRNA Vaccine
mRNA COVID-19 Vaccines Safety for Previous Vaccine Reactions
Phase 4
Recruiting
Led By James Baker, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be able to understand and provide informed consent
Age over 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 days after the vaccine is given
Awards & highlights
Study Summary
This trial is being conducted to see if people who have had bad reactions to COVID-19 vaccines in the past can safely have another dose, or if people with a history of allergies can safely have the vaccine at all.
Who is the study for?
This trial is for adults over 18 who've had adverse reactions to previous mRNA COVID-19 vaccines, allergic reactions without prior vaccination, or issues after a natural COVID infection. They must not be pregnant, immunocompromised, have immune disorders, recent COVID-19 infections or treatments with antibody agents.Check my eligibility
What is being tested?
The study tests the safety of an additional dose of Pfizer-BioNTech or Moderna bivalent mRNA COVID-19 vaccine in those with past adverse reactions to vaccines or 'long COVID', and initial doses in those with a history of allergies.See study design
What are the potential side effects?
Potential side effects may include typical vaccine-related responses such as soreness at injection site, fatigue, headache, muscle pain, chills, fever and nausea. Severe allergic reactions are rare but will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study and can give my consent.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 7 days after the vaccine is given
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 7 days after the vaccine is given
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment-related allergic reaction adverse events
Percent of participants that have a reaction to an initial or additional dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine
Secondary outcome measures
Number of clinical adverse reaction types (non-allergic)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pfizer-BioNTech mRNA COVID-19 vaccine or Moderna mRNA COVID-19 vaccineExperimental Treatment2 Interventions
Subject will receive an initial or additional dose of either the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine or the Moderna (Spikevax) mRNA COVID-19 vaccine
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,858 Total Patients Enrolled
21 Trials studying COVID-19
19,984 Patients Enrolled for COVID-19
The Wallace FoundationUNKNOWN
James Baker, MDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.You had a bad allergic reaction to a certain COVID-19 vaccine in the past.You have had a severe allergic reaction to a specific COVID vaccine, any severe allergic reaction without having a COVID vaccine, or a bad reaction to getting COVID.I had COVID-19 within the last 21 days before my vaccine appointment.My immune system is weak.I am of childbearing age and have a negative pregnancy test.I understand the study and can give my consent.I am over 18 years old.I haven't been sick with an infection in the last 14 days.You have a history of an immune system disorder.I have not received COVID-19 antibodies or plasma treatment in the last 90 days.
Research Study Groups:
This trial has the following groups:- Group 1: Pfizer-BioNTech mRNA COVID-19 vaccine or Moderna mRNA COVID-19 vaccine
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people can enroll in this experiment at one time?
"The information on clinicaltrials.gov verifies that this study is currently looking for candidates. The posting date was March 21st, 2020 and the most recent edit was on April 23rd, 2020. They are hoping to find 200 participants total from one location."
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