A Phase 3 study of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age

• IRAS ID

  1013654

• Contact name

  Hiwot Hiruy

• Contact email

  hiwot.hiruy@modernatx.com

• Sponsor organisation

  ModernaTX, Inc.

• Clinicaltrials.gov Identifier

  NCT07496450

• Research summary

  ModernaTX, Inc. is sponsoring this research to learn about an experimental vaccine for a pandemic flu. There is an ongoing concern that a new type of flu virus could suddenly spread around the world. One possible threat is a bird flu virus called H5N1. Because of this risk, researchers want to test a new vaccine that could be used if such a pandemic happens.
  The experimental vaccine being studied in this trial is called mRNA-1018-H5. It is designed to protect people against a specific group of flu viruses, including H5N1.
  This trial will include healthy men and women who are 18 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 receive mRNA-1018-H5 or a placebo (an identical treatment with no active ingredients). Participants will receive assigned treatment on Days 1 and 22. Treatments will be given as injections into a muscle.
  The trial will be conducted at several sites (such as hospitals, general practitioner surgeries, private medical research clinics, and/or academic medical centers) in multiple countries, including the United Kingdom.
  Participants will visit a trial site at least 5 times. Participants will be in the trial for up to 7 months.
  Trial doctors will keep track of the participants’ health and take blood samples to learn about their immune response to the injection.
  The main goal of the trial is to learn about the immunogenicity of mRNA-1018-H5. The immunogenicity of a vaccine measures how well it teaches our immune system to fight a virus. Another main goal is to learn about the safety and reactogenicity of mRNA-1018-H5. The reactogenicity of a vaccine describes its potential to cause a reaction, such as a fever or soreness at the injection site, soon after it is given.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  26/SC/0056

• Date of REC Opinion

  13 Mar 2026

• REC opinion

  Further Information Favourable Opinion