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Cancer Vaccine
mRNA Vaccine for COVID-19
Phase 4
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants had previous mRNA COVID-19 vaccination
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial aims to study how well a COVID-19 vaccine works against different variants of the virus in adults who have already been vaccinated.
Who is the study for?
This trial is for adults who've already had an mRNA COVID-19 vaccine and can follow the study rules. They must not be pregnant, have a negative pregnancy test before getting the shot, and use birth control or abstain from sex that could lead to pregnancy from 28 days before until 28 days after vaccination.
What is being tested?
The study tests new versions of the mRNA-1273 vaccine designed to fight different COVID-19 variants. It checks how well these updated vaccines work against both known and emerging variants in people who've been vaccinated before.
What are the potential side effects?
Possible side effects include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea; similar to those reported for other mRNA COVID-19 vaccines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received an mRNA COVID-19 vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: mRNA-1273 Variant-containing FormulationExperimental Treatment1 Intervention
Participants will receive an intramuscular (IM) injection of a mRNA-1273 variant-containing formulation.
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
121 Previous Clinical Trials
66,784,974 Total Patients Enrolled
41 Trials studying COVID-19
66,580,890 Patients Enrolled for COVID-19