Trial intelligence / Profile preview

mRNA-1020 and mRNA-1030 Influenza Vaccines in Healthy Adults

NCT05333289Phase 2

Key facts

Status
Completed
Start
Apr 2022
Primary completion
Nov 2022
Countries
1
Modality
Vaccines & Immunotherapeutics, Lipid-based Nanoparticles, mRNA Therapeutics
Conditions
seasonal influenza
01

Overview

Phase 2, randomised, single-blind trial of mRNA-1020 and mRNA-1030 in seasonal influenza (8 arms), sponsored by Moderna Inc. Primary endpoints: Number of Participants With Solicited Local and Systemic Adverse Reactions at Day 7, Number of Participants With Unsolicited Adverse Events at Day 28 and 7 more. Started Apr 2022; status: completed.

02

Design

8 arms
Study design
RandomizedSingle-blind
  • mRNA-1030 Dose A

    mRNA-1030 at Dose Level A

  • mRNA-1020 Dose A

    mRNA-1020 at Dose Level A

  • mRNA-1030 Dose B

    mRNA-1030 at Dose Level B

  • mRNA-1020 Dose B

    mRNA-1020 at Dose Level B

  • mRNA-1030 Dose C

    mRNA-1030 at Dose Level C

  • mRNA-1020 Dose C

    mRNA-1020 at Dose Level C

2 more in the full profile.

03

Who it enrols

Healthy adults aged 18-75 years with a BMI of 18-35 kg/m^2 who have not received a recent influenza vaccine.

04

Endpoints

Primary

  • Number of Participants With Solicited Local and Systemic Adverse Reactions

  • Number of Participants With Unsolicited Adverse Events

  • Number of Participants With Medically-Attended AEs, AESI, AEs Leading to Withdrawal and SAEs

  • Geometric Mean Titer of Anti-Hemagglutinin Antibodies

  • Geometric Mean Titer of Anti-Neuraminidase Antibodies

Secondary

  • GMT of Anti-HA or Anti-NA Antibodies

  • GMFR of Anti-HA or Anti-NA Antibodies

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