Evidence map›Paper›PMID 40953212›Full record

Trial reportHuman vaccines & immunotherapeutics2025

Safety and immunogenicity of an mRNA-based RSV vaccine in seropositive children aged 12-59 months.

Sabine Schnyder Ghamloush, Sue Fanning, Brandon Essink, Frank Eder, Matthew D Snape, Sonia K Stoszek, Ruiting Guo, Rakesh Dhar, Vinicius Righi, Louie Morsy and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04528719 (A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04528719 phase1completednot on this map

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Healthy Younger Adults Aged 18 to 49 Years, Women of Child-Bearing Potential Aged 18 to 40 Years, Healthy Older Adults Aged 65 to 79 Years, Japanese Older Adults Aged ≥ 60 Years, and RSV-Seropositive Children Aged 12 to 59 Months

TypeinterventionalSponsorModernaTX, Inc.Ran2020 to 2024Enrolled651ConditionsRespiratory Syncytial VirusArmsmRNA-1345, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Development of mRNA vaccines against herpes zoster.Human vaccines & immunotherapeutics · 2026
    Review
  2. Article
  3. Review
  4. 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

13 authors.

Sabine Schnyder GhamloushModerna, Inc., Cambridge, MA, USA.
Sue FanningThe Alliance for Multispecialty Research, LLC, Knoxville, TN, USA.
Brandon EssinkVelocity Clinical Research, Omaha, NE, USA.
Frank EderVelocity Clinical Research, Omaha, NE, USA.
Matthew D SnapeModerna Biotech Manufacturing UK, Harwell Science and Innovation Centre, Didcot, UK.
Sonia K StoszekModerna, Inc., Cambridge, MA, USA.
Ruiting GuoModerna, Inc., Cambridge, MA, USA.
Rakesh DharModerna, Inc., Cambridge, MA, USA.
Vinicius RighiModerna, Inc., Cambridge, MA, USA.
Louie MorsyModerna, Inc., Cambridge, MA, USA.
Archana KapoorModerna, Inc., Cambridge, MA, USA.
Laila El AsmarModerna, Inc., Cambridge, MA, USA.
Christine A ShawModerna, Inc., Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Respiratory syncytial virus (RSV) is a common respiratory pathogen in children. After demonstrating safety and immunogenicity in adults, mRNA-1345 encoding the RSV prefusion (preF) stabilized F glycoprotein was investigated in children. This phase 1, randomized, observer-blind study assessed the safety and immunogenicity of mRNA-1345 (NCT04528719) in RSV-seropositive children (per microneutralization assay) aged 12-59 months and is part of a larger study in multiple populations. Participants received three doses of mRNA-1345 (15 μg or 30 μg) or placebo 56 days apart, with 12-month safety follow-up. Forty-six participants were randomized to receive mRNA-1345 15 μg (

Indexed as

Immunogenicity, VaccineRespiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAntibodies, NeutralizingAntibodies, ViralChild, PreschoolDrug-Related Side Effects and Adverse ReactionsFemaleHumansInfantMalePlacebosRNA, MessengerVaccines, SyntheticViral Fusion ProteinsAntibodies, NeutralizingAntibodies, ViralPlacebosRespiratory Syncytial Virus VaccinesRNA, MessengerVaccines, SyntheticViral Fusion Proteinsimmunogenicityphase 1 trialRespiratory syncytial virusRSV-seropositive childrenRSV vaccinesafety

Identifiers

PMID40953212
PMCPMC12439546

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.