*A Phase 3 Study of mRNA-1403 Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults
Research type
Research Study
Full title
A Phase 3, Randomized, Observer-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of mRNA-1403, a Multivalent Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults ≥18 Years of Age
IRAS ID
1009982
Contact name
Meklit Workneh
Contact email
Sponsor organisation
ModernaTX, Inc.
Clinicaltrials.gov Identifier
Research summary
ModernaTX, Inc. is sponsoring this research to learn more about a possible vaccine to prevent acute gastroenteritis (AGE) caused by norovirus (NoV). AGE is a common condition that can cause inflammation in the stomach and intestines, leading to diarrhea and vomiting. AGE is often caused by viruses, such as NoV.
The experimental vaccine being studied in this trial is called mRNA-1403.
This trial will include men and women aged 18 years and older. People with certain medical conditions or people who need to take certain medications may not be able to take part. Those with chronic medical conditions that are well-controlled may still be able to participate.
Participants will be assigned to receive mRNA-1403 or a placebo (an identical-looking treatment with no active ingredients). Participants will receive their assigned treatment once on Day 1, as a single injection into a muscle.
The trial will be conducted at sites (hospitals, general practitioner [GP] offices, and/or academic medical centers) in multiple countries, including the United Kingdom.
Participants will visit a trial site regularly. Participants will be in the trial for up to about 2 years.
During site visits, trial doctors will keep track of any medical problems the participants have and check their health. Trial doctors will also monitor the participants for NoV infection and AGE symptoms.
The main goals of the trial are to learn about the safety and reactogenicity of mRNA-1403 and to learn how well it works to prevent AGE caused by NoV. The reactogenicity of a drug describes its potential to cause a known reaction, such as a fever or soreness at the injection site. To learn this, doctors will ask about any new or worsening medical problems participants have after the vaccine. They will also monitor the participants for NoV infection and check any AGE symptoms they develop during the trial.REC name
Wales REC 1
REC reference
24/WA/0195
Date of REC Opinion
2 Oct 2024
REC opinion
Further Information Favourable Opinion