CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,900 enrolled
Drug / intervention
Placebo +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06060457
NCT06060457Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Observer-Blind Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, When Coadministered With a High-Dose, Quadrivalent Seasonal Influenza Vaccine in Adults ≥65 Years of Age

ModernaTX, Inc.·interventional·Posted Sep 29, 2023·Updated Jul 30, 2025

In Brief

A Phase 3 clinical trial evaluating Placebo, mRNA-1345, and 1 other intervention for Respiratory Syncytial Virus. Completed, enrolled 1,900 participants across 34 sites.

Detailed Summary

The main purpose of this study is to evaluate the safety and immunogenicity of mRNA-1345 RSV vaccine when coadministered with a high dose (HD) quadrivalent seasonal influenza vaccine (Fluzone HD) in adults ≥65 years of age. The study will examine the impact of Fluzone HD on the immune response to mRNA-1345 against RSV-A and RSV-B, as well as the impact of mRNA-1345 on the immune response to Fluzone HD against 4 vaccine-matched Influenza A and B strains.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedSep 29, 2023
Enrollment StartSep 25, 2023
Primary CompletionJun 7, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.8 years ago

Interventions

Placebobiological

0.9% sodium chloride (normal saline) injection

mRNA-1345biological

Suspension for injection

Fluzone HDbiological

Suspension for injection