Phase 1 Study to Evaluate Safety and Immunogenicity of Multicomponent Vaccines in Healthy Adults

• Research type

  Research Study

• Full title

  Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-Component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age

• IRAS ID

  1005995

• Contact name

  Roderick McPhee

• Contact email

  Roderick.McPhee@modernatx.com

• Sponsor organisation

  ModernaTX, Inc.

• Eudract number

  2022-002138-15

• Research summary

  Moderna TX.,Inc. is developing multiple vaccines for the prevention of diseases caused by several respiratory viruses including influenza, Respiratory Syncytial Virus (RSV), and the virus that causes COVID-19 (SARS-CoV-2). This clinical trial will evaluate and compare two new multi-component vaccines against these viruses (mRNA-1045 [influenza and RSV] and mRNA-1230 [influenza, RSV, and SARS-CoV-2]) to three individual vaccines already being studied: mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2).
  The main goals of the trial are to determine the safety of the vaccines and to measure the body’s immune responses to the vaccines. The trial will enroll approximately 675 healthy adults 50 to 75 years of age across multiple clinical sites in North America, Europe, and Australia.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  22/EE/0226

• Date of REC Opinion

  8 Nov 2022

• REC opinion

  Further Information Unfavourable Opinion