A Study of mRNA-1010 Candidate Influenza Vaccine in Adults ≥50 Years of Age
Research type
Research Study
Full title
A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared with a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age
IRAS ID
1009760
Contact name
Mieke Soens
Contact email
Sponsor organisation
ModernaTX, Inc.
Clinicaltrials.gov Identifier
Research summary
ModernaTX, Inc. is sponsoring this research to learn more about a possible treatment to prevent seasonal influenza (flu) in people who are 50 years or older. Flu is caused by a virus. Symptoms of the flu include a fever, cough, sore throat, and headaches. Flu is more likely to cause serious medical problems for older adults.
The experimental vaccine treatment being studied in this trial is called mRNA-1010.
This trial will include participants who are 50 years or older. People with certain medical conditions or people who need to take certain medications may not be able to take part.
Participants will be assigned to receive mRNA-1010 or a vaccine that is already available to prevent flu. Participants will receive their assigned treatment once on Day 1, as a single injection into a muscle.The trial will be conducted at sites (hospitals, general practitioner (GP) surgeries, and/or academic medical centres) in multiple countries, including the United Kingdom.
Participants will visit a trial site regularly. Participants will be in the trial for up to about 6 to 8 months.
During site visits, trial doctors will keep track of the participants’ health and take blood samples to learn about their immune response to the injection.
The main goals of the trial are to learn about the safety of mRNA-1010 and how well it works to prevent flu compared to a vaccine that is already available. To learn this, doctors will study any new or worsening medical problems participants have after treatment. They will also monitor any flu-like illness that participants develop during the trial.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0636
Date of REC Opinion
12 Sep 2024
REC opinion
Further Information Favourable Opinion