A Clinical Trial to Evaluate an Investigational Vaccine for Norovirus
Now Enrolling: Adults Aged 60+
Clinical trial sites near you are seeking participants for Moderna’s Nova 301 Trial. This Phase 3 clinical trial will evaluate the safety, effectiveness, and immune response of an investigational vaccine aimed at preventing norovirus disease. Norovirus can spread quickly through everyday social interactions and cause disruptive symptoms such as vomiting and diarrhea. In severe cases, these symptoms can lead to dehydration, which may require hospitalization or IV fluids.
The Potential of mRNA Vaccines
The investigational vaccine being evaluated is a messenger RNA (mRNA) vaccine. An mRNA vaccine aims to teach the body how to make a specific protein that may potentially help your immune system prevent or treat certain diseases. The investigational vaccine in this clinical trial, mRNA-1403, aims to protect against norovirus and has been previously studied in Phase 1 and 2 trials. You cannot get norovirus from the investigational vaccine.
What to Expect
Your participation in the Nova 301 Trial will last about 2 years. You will have at least 6 clinic visits and 6 phone calls to check in on you. You will be given 1 injection in the upper arm. You must complete a brief symptom-reporting electronic diary (eDiary) entry every day for 7 days after the injection and weekly for the remainder of the clinical trial. You must reach out to the clinical trial team if you experience any acute gastroenteritis symptoms, such as vomiting and diarrhea, during the trial. If you report symptoms, you may be asked to provide a stool sample.
Will Everyone Get the Investigational Vaccine?
To understand whether the investigational vaccine works and is safe, it will be compared with a placebo. A placebo does not include any active ingredients.
You will be randomly assigned—like flipping a coin—to receive mRNA-1403 or the placebo. All clinical trial participants will get the same level of trial-related care regardless of which trial injection they receive.
Diseases do not discriminate — and neither should clinical trials.
Moderna is committed to researching safe and effective mRNA-based vaccines and therapies to bring better health and living to people of all ages, sexes, and backgrounds.
Doctor Kivitz explains how clinical trials may be right for you.
