The double-blind, placebo-controlled, randomised ConquerRSV trial was designed for evaluating the safety and efficacy of the mRNA-1345 vaccine.
It will also show the efficacy of an mRNA-1345 vaccine single dose in preventing a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD), compared to a placebo, from 14 days after injecting through to 12 months.
Nearly 37,000 adult patients aged 60 years or above were enrolled in 22 countries, including the US.
The findings demonstrated that mRNA-1345 showed an 83.7% vaccine efficacy (VE) against RSV-LRTD, as defined by two or more symptoms, which were the trial’s primary efficacy endpoints.
A vaccine efficacy of 82.4% was observed in individuals with three or more symptoms.
An independent Data and Safety Monitoring Board reviewed the data in the ConquerRSV study.
The vaccine was also found to be well tolerated, and no safety concerns were identified.
Moderna intends to seek regulatory approval for the vaccine in the first half of this year using these results.
Moderna CEO Stéphane Bancel said: “Today’s results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older.
“These data are encouraging and represent the second demonstration of positive Phase III trial results from our mRNA infectious disease vaccine platform after Spikevax, our Covid-19 vaccine.
“We look forward to publishing the full data set and sharing the results at an upcoming infectious disease medical conference.”
In November last year, Moderna reported findings from a Phase II/III clinical trial where bivalent Omicron-targeting booster candidates, mRNA-1273.214 and mRNA-1273.222, met the primary endpoint of superiority against Omicron BA.4/BA.5 variants versus the mRNA-1273 booster.
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