Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Flu Vaccine in Adults

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older.

• IRAS ID

  1006000

• Contact name

  Jintanat Ananworanich

• Contact email

  Jintanat.Ananworanich@modernatx.com

• Sponsor organisation

  ModernaTX, Inc.

• Eudract number

  2022-001638-12

• Clinicaltrials.gov Identifier

  NCT05566639

• Research summary

  Seasonal flu viruses are estimated by the World Health Organization (WHO) to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year resulting in a severe challenge to public health. Currently licensed seasonal flu vaccines rarely exceed 60% overall effectiveness and are poorly effective during years when the circulating viruses do not match the strains selected for the vaccine. The purpose of this study is to test the Sponsors proprietary seasonal flu vaccine, known as mRNA 1010.
  The Sponsor developing a flu vaccine with mRNA encapsulated in a lipid nanoparticle (a lipid-based drug delivery system with increased stability) against disease caused by flu virus types A and B.
  The main goals of this study are:
  • To see how safe mRNA-1010 is in adults, and
  • To see if mRNA-1010 can provide better protection against influenza A and B when compared to Fluarix® Quadrivalent (also known as Fluarix® Tetra in the UK).

  Participants will be randomised in a 1:1 ratio to receive a single dose of mRNA 1010 at 50 micrograms total mRNA or a single dose of the active comparator. Randomisation will be stratified by age categories (≥ 50 to < 65 years or ≥ 65 years) and influenza vaccine status in the previous influenza season (received or not received) at the time of screening.
  Participants will be in the study for approximately 13 months during which they will have to complete electronic questionnaires on a smartphone and have regular follow-up calls at scheduled timepoints.
  About 23,000 adults, 50 years of age and older, will take part in this study across multiple sites in North America, Europe, and Asia.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  22/LO/0616

• Date of REC Opinion

  4 Oct 2022

• REC opinion

  Further Information Favourable Opinion