Norovirus Vaccine Study

Last updated: September 22, 2023
Sponsor: N/A
Overall Status: Active - Recruiting

Phase

N/A

Condition

Healthy Patient Studies

Healthy Volunteers

Treatment

N/A

Clinical Study ID

TX318213
  • Ages 18-90
  • All Genders

Study Summary

You may have heard of norovirus, sometimes called food poisoning or the stomach bug.You'll likely remember if you've had it. These symptoms, often known as acute gastroenteritis, generally last for 1 to 3 days. You can imagine how these symptoms can cause a major disruption to your daily life. Norovirus spreads quickly through interactions in places like day care centers, nursing homes, and restaurants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Who can join this study?

**
**

  • Be 18 to 49 or 60 to 80 years of age
  • Be in good health
  • Not be pregnant or planning on becoming pregnant for at least 3 months following the final vaccine visit

Study Design

Study Start date:
Estimated Completion Date:

Study Description

The Nova Trial will evaluate the safety and immune response of messenger RNA (mRNA)based investigational vaccines aimed at preventing norovirus and its serious symptoms. By participating, you play an important part in the development of a potential new vaccine for an illness that currently has none.

What Are Investigational mRNA Vaccines?

The investigational vaccines being evaluated are mRNA vaccines. mRNA vaccines aim to teach the body how to make a specific protein that may potentially help your immune system prevent or treat certain diseases and illnesses. The hope is that the investigational vaccines train immune system cells to remember these proteins and help the body quickly protect against the strain of infection if exposed in the future. The investigational vaccines in this clinical trial, mRNA-1403 and mRNA-1405, aim to protect against norovirus.

**Will Everyone Get an Investigational Vaccine? **

To understand whether the investigational vaccines work and are safe, they 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 a certain dose of mRNA-1403, mRNA-1405, or the placebo. All clinical trial participants will get the same level of trial-related care regardless of which injections they receive.

**What to Expect **

_Participation in the Nova Trial will last 14 months. _

  • You will have at least 11 clinic visits and 8 phone calls to check in on you. We will schedule your trial visits to minimize disruptions to your work and other commitments
  • You will be given a total of 2 injections in the upper arm, each during a separate visit
  • You must complete a symptom-reporting electronic diary (eDiary) entry every day for 7 days after each injection , starting on and including the day of injection
  • Enrolling in this clinical trial is completely your choice. You may stop participating in the trial at any time, and you do not have to give a reason for doing so
  • Qualified participants will receive payment for their trial-related time and travel

Connect with a study center

  • Ark Clinical Research

    Long Beach, California 90815
    United States

    Active - Recruiting

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