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NCT05972174Recruiting

A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age
ModernaTX, Inc.Phase 1/2ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Influenza
Drug/Device/Intervention
mRNA-1018 for H5N8
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
ModernaTX, Inc.
Location
South Jordan, United States of America
Timeline & enrollment
Phase
Phase 1/2
Start date
Jul 10, 2023
End date
May 22, 2024
Enrollment
1500 participants
Primary outcome

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs),Number of Participants with Unsolicited Adverse Events (AEs),Number of Participants with AEs Leading to Discontinuation From Study,Number of Participants with Medically-Attended AEs (MAAEs),Number of Participants with Serious Adverse Events (SAEs),Number of Participants with Adverse Events of Special Interest (AESIs)

Summary

The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data
 of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to
 enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study
 will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part
 A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B
 of the study will evaluate a single vaccine candidate (H5 only-CG).

ICD-10 classifications
Influenza and pneumoniaInfluenza due to identified seasonal influenza virusInfluenza with other manifestations, seasonal influenza virus identifiedInfluenza with pneumonia, seasonal influenza virus identifiedInfluenza due to identified zoonotic or pandemic influenza virus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05972174
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05972174 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by ModernaTX, Inc. and is currently Recruiting. The study focuses on Influenza. Target enrollment is 1500 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.