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Virus Therapy
mRNA-1403 for Stomach Flu (Nova 301 Trial)
Phase 3
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
History of AGE within 14 days prior to Day 1 or close contact with an individual with AGE symptoms (in the home, socially, or occupationally) within 14 days prior to Day 1.
Has undergone surgical procedures within 7 days prior to Day 1 or is scheduled to undergo a surgical procedure within 28 days after study intervention.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
Summary
This trial aims to test the safety and effectiveness of mRNA-1403 in preventing moderate to severe stomach flu caused by specific strains of the virus.
Who is the study for?
This trial is for adults over 18 years old who want to prevent severe stomach flu caused by norovirus. Participants should be healthy with no recent history of gastroenteritis and not pregnant. They can't join if they've had a bad reaction to vaccines before or are on medications that affect the immune system.
What is being tested?
The study tests mRNA-1403, which is a new vaccine aimed at preventing acute gastroenteritis from norovirus. Some participants will receive the actual vaccine while others will get a placebo, and researchers will compare results between these two groups.
What are the potential side effects?
Possible side effects include typical reactions seen with other vaccines such as soreness at injection site, fever, fatigue, headache, muscle pain, and chills. The severity of these side effects varies among individuals.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had acute gastroenteritis or been in close contact with someone who has, within the last 14 days.
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I haven't had surgery in the last 7 days and won't have any for the next 28 days.
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I haven't received any blood products or immunoglobulins in the last 3 months.
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I have a history of immune system problems or severe infections.
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I was diagnosed with cancer, other than nonmelanoma skin cancer, in the last 2 years.
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I have had Guillain-Barre syndrome in the past.
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I have a bleeding disorder that makes injections or blood draws unsafe.
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I have not taken strong immune system suppressing drugs for more than 2 weeks in the last 6 months.
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
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: mRNA-1403Experimental Treatment1 Intervention
Participants will receive a single injection of mRNA-1403 on Day 1.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single injection of mRNA-1403 matching placebo (0.9% sodium chloride solution) on Day 1.
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
121 Previous Clinical Trials
61,563,389 Total Patients Enrolled