The study is designed to recruit up to 10,000 participants aged 18 to 84, with and without relevant comorbidities, over the next four to six weeks.
It is intended to involve at least 25% of subjects over the age of 65 and also prioritize the groups most affected by Covid-19, including racial and ethnic minorities.
During the randomized, placebo-controlled, blinded trial, 50% of the volunteers will receive two intramuscular injections of the vaccine candidate, 21 days apart, while the rest will receive a placebo.
The vaccine dose will consist of 5 µg of protein antigen and 50 µg of Matrix-M adjuvant.
Novavax added that as part of a co-administration sub-study, up to 400 participants will also receive a licensed seasonal influenza vaccine.
The first primary endpoint of the phase III trial is the first occurrence of symptomatic Covid-19 confirmed by PCR with an onset at least seven days after the second vaccination in subjects without previous infection with SARS-CoV -2.
In addition, the trial will assess the second primary endpoint as the first occurrence of moderate or severe symptomatic Covid-19 confirmed by PCR with onset at least seven days after the second vaccination in those who had no previous infection. by the virus.
An event assessment based on the number of volunteers with symptomatic or moderate / severe Covid-19 will be performed as the primary efficacy analysis.
Gregory Glenn, President of Novavax Research and Development, said: “With a high level of transmission of SARS-CoV-2 observed and expected to continue in the UK, we are optimistic that this pivotal Phase III clinical trial will continue. will quickly register and provide a short-term view of the effectiveness of NVX-CoV2373.
“The data from this trial should support regulatory licensing submissions in the UK, EU and other countries.”
Based on Novavax recombinant protein nanoparticle technology, the Covid-19 vaccine candidate has also undergone phase I and phase II trials.