Evidence map›Paper›PMID 42441816›Full record

Trial reportHuman vaccines & immunotherapeutics2026

Optimized seasonal influenza mRNA vaccine compositions demonstrate safety and enhanced immunogenicity in a phase 2 study.

Carlos Fierro, Miaoxin Lin, Bethany Girard, Shannon McGrath, Xiaolin Chang, Qi Wu, Hsiao-Hsuan Kuo, Cathal Harmon, Jaap Oostendorp

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05868382 (A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05868382 phase2completednot on this map

A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age

TypeinterventionalSponsorModernaTX, Inc.Ran2023 to 2023Enrolled270ConditionsInfluenzaArmsmRNA-1010, mRNA-1010.4, mRNA-1010.6
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Carlos FierroJohnson County Clin-Trials, Clinical Research, Lenexa, KS, USA.
Miaoxin LinModerna, Inc., Cambridge, MA, USA.
Bethany GirardModerna, Inc., Cambridge, MA, USA.
Shannon McGrathModerna, Inc., Cambridge, MA, USA.
Xiaolin ChangModerna, Inc., Cambridge, MA, USA.
Qi WuModerna, Inc., Cambridge, MA, USA.
Hsiao-Hsuan KuoModerna, Inc., Cambridge, MA, USA.
Cathal HarmonModerna, Inc., Cambridge, MA, USA.
Jaap OostendorpModerna, Inc., Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Seasonal influenza causes considerable morbidity and mortality, with influenza A and B viruses driving most influenza-associated hospitalizations and deaths. Vaccination remains a key influenza prevention strategy; however, current seasonal influenza vaccines based on traditional platforms provide inconsistent protection. Messenger RNA - based vaccines may offer several key advantages over other vaccines, including the flexibility to optimize antigen expression to enhance immunogenicity without the need for adjuvants. mRNA-1010 is an investigational seasonal influenza vaccine candidate that encodes hemagglutinins (HAs) from WHO-recommended influenza strains. In this randomized, phase 2 study, safety, reactogenicity, and immunogenicity of 3 mRNA-1010 vaccine candidate compositions were evaluated in healthy adults aged 18-49 y in the United States (NCT05868382). Eligible participants were randomly assigned to receive a single dose of one of the mRNA-1010 compositions at several dose levels. The primary objective was the safety and reactogenicity of mRNA-1010 vaccine candidate compositions against vaccine-matched strains; secondary and exploratory objectives included humoral and cellular immunogenicity at evaluable timepoints, respectively. Two hundred and seventy participants received study vaccination between May and December 2023. All mRNA-1010 vaccine compositions were well tolerated, with no safety concerns identified; all compositions induced HA-specific humoral and cellular immune responses against all influenza strains evaluated, with the optimized compositions exhibiting higher immune responses against influenza B strains compared with the original mRNA-1010 composition. These results, together with findings from other mRNA-1010 clinical studies, support continued evaluation of mRNA-1010 for enhanced protection against seasonal influenza.

Indexed as

Immunogenicity, VaccineInfluenza, HumanInfluenza VaccinesAdolescentAdultAntibodies, ViralFemaleHemagglutinin Glycoproteins, Influenza VirusHumansInfluenza B virusMaleMiddle AgedmRNA VaccinesRNA, MessengerUnited StatesVaccines, SyntheticAntibodies, ViralHemagglutinin Glycoproteins, Influenza VirusInfluenza VaccinesmRNA VaccinesRNA, MessengerVaccines, SyntheticImmunogenicityinfluenzamRNA vaccinereactogenicitysafety

Identifiers

PMID42441816
PMCPMC13367079

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.