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Clinical Trial
. 2025 Mar 19:50:126847.
doi: 10.1016/j.vaccine.2025.126847. Epub 2025 Feb 7.

A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults

Mieke Soens  1 , Jintanat Ananworanich  2 , Bryony Hicks  3 , Kathryn Jean Lucas  4 , Jose Cardona  5 , Lawrence Sher  6 , Greg Livermore  2 , Kristi Schaefers  2 , Carole Henry  2 , Angela Choi  2 , Andrei Avanesov  2 , Ren Chen  2 , Evelyn Du  2 , Alicia Pucci  2 , Rituparna Das  2 , Jacqueline Miller  2 , Raffael Nachbagauer  2
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Free article
Clinical Trial

A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults

Mieke Soens et al. Vaccine. .
Free article

Abstract

Background: Messenger RNA (mRNA)-based influenza vaccines have the potential to improve upon limitations of current vaccine approaches to seasonal influenza.

Methods: Here we report findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of the quadrivalent mRNA vaccine, mRNA-1010, versus licensed standard-dose and high-dose quadrivalent influenza vaccines from a three-part, phase 3 clinical trial in adults aged ≥18 years (Part A), 18-64 years (Part B), and ≥ 65 years (Part C) (NCT05827978).

Results: A single 50-μg dose of mRNA-1010 elicited hemagglutination inhibition titers against vaccine-matched strains that were statistically noninferior and superior to licensed standard-dose and high-dose egg-based quadrivalent vaccine comparators. Solicited adverse reactions were more frequent with receipt of mRNA-1010; adverse reactions were lower in frequency and severity among adults aged ≥65 years than younger adults. No safety concerns were identified.

Conclusions: These findings support the potential benefit of mRNA-1010 as a seasonal influenza vaccine.

Keywords: Immunogenicity; Reactogenicity; Safety; Seasonal influenza; mRNA vaccine; mRNA-1010.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Mieke Soens reports financial support was provided by Moderna Inc. Jintanat Ananworanich, Bryony Hicks, Kathryn Jean Lucas, Jose Cardona, Lawrence Sher, Greg Livermore, Kristi Schaefers, Carole Henry, Angela Choi, Andrei Avanesov, Ren Chen, Evelyn Du, Alicia Pucci, Rituparna Das, Jacqueline Miller, Raffael Nachbagauer reports financial support was provided by Moderna Inc. Mieke Soens, Bryony Hicks, Greg Livermore, Kristi Schaefers, Carole Henry, Angela Choi, Andrei Avanesov, Ren Chen, Evelyn Du, Alicia Pucci, Rituparna Das, Jacqueline Miller, Raffael Nachbagauer reports a relationship with Moderna Inc that includes: employment and equity or stocks. Kathryn Jean Lucas reports a relationship with Moderna Inc that includes: consulting or advisory. Lawrence Sher reports a relationship with Moderna Inc that includes: non-financial support. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper

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