US-based pharmaceutical company Moderna has dosed the first subject in the US in its Phase III Nova 301 clinical trial of its investigational norovirus vaccine, mRNA-1403.
The Nova 301 trial aims to evaluate the vaccine’s efficacy, safety and immunogenicity on a global scale.
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The observer-blind, randomised, placebo-controlled study has begun recruitment and will expand its recruitment efforts worldwide.
It is expected to enrol around 25,000 adults aged 18 years and older from various geographical regions.
Of these participants, around 20,000 will be aged 60 years and above, while 5,000 will be between the ages of 18 and 59 years.
Participants from countries in the Northern Hemisphere such as the US, Canada, the UK and Japan, as well as equatorial regions and the Southern Hemisphere such as Australia and South America, will be part of the trial.
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By GlobalDataIn the trial, the vaccine’s potential to protect against moderate to severe acute gastroenteritis (AGE) caused by norovirus, particularly in older adults who are more susceptible to severe consequences such as hospitalisation, will be assessed.
mRNA-1403 is a trivalent mRNA formulation designed to induce an immune response against multiple norovirus genotypes by encoding virus-like particles.
Moderna CEO Stéphane Bancel said: “Norovirus is a significant public health concern that affects millions of people worldwide each year, leading to severe symptoms and, in some cases, hospitalisation.
“By advancing our investigational norovirus vaccine into a pivotal Phase III trial, we are one step closer to potentially providing a new tool to prevent infection from this highly contagious virus, which places a significant burden on health systems globally.”
Earlier this year, Moderna announced that its Phase III trial of the investigational next-generation Covid-19 vaccine, mRNA-1283, met its primary efficacy endpoint.
The vaccine demonstrated non-inferior efficacy against Covid-19 compared with Spikevax (mRNA-1273) in the trial.
mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
