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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
Must not have
Under age 18
Immunocompromised
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 7 days after the vaccine is given
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
All Individual Drugs Already Approved
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
My immune system is weak.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with treatment-related allergic reaction adverse events
Secondary study objectives
Number of clinical adverse reaction types (non-allergic)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pfizer-BioNTech mRNA COVID-19 vaccineExperimental Treatment1 Intervention
Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,434,861 Total Patients Enrolled
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
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.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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