mRNA1345 mRNA 1365 RSV_hMPV in babies

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Observer-blind, Placebo-controlled, Age De-escalation Study of the Safety, Tolerability, and Immunogenicity of mRNA-1345 and mRNA-1365 in Participants Aged 5 months to <24 months

• IRAS ID

  1006997

• Contact name

  Matthew Snape

• Contact email

  Matthew.snape@modernatx.com

• Sponsor organisation

  ModernaTX, Inc.

• Eudract number

  2022-502022-41

• Clinicaltrials.gov Identifier

  NCT05743881

• Research summary

  Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are very common viruses that infect the lungs and respiratory tract – the parts of the body related to breathing. They can cause a runny nose, sore throat, cough, fever, and headache but can also lead to more serious disease, such as pneumonia, in young children. RSV is the most common cause of chest infection in young children. In 2019, it was associated with over 100,000 deaths of children across the world. Globally, an estimated 11.1 million chest infections, 502,000 hospital admissions, and 11,300 deaths were attributed to hMPV in 2018. Infants under 12 months of age are particularly affected. There are no approved vaccines to prevent RSV or hMPV.

  This study will help researchers learn about 2 new Moderna study vaccines against RSV and hMPV in children. The main goals of this study are to learn:
  • How safe the study vaccines are for children
  • How children’s immune systems respond to the study vaccines
  • How well the study vaccines work to prevent infection RSV and hMPV disease in children

  Children taking part will be randomly given 1 of the 3 study injections (either of the 2 vaccines or a placebo- a harmless, inactive substance- injection) with an equal chance of being given each injection. They will then be followed up for about 24 months (2 years). In total about 210 children between 5 and 23 months old will take part in this study across multiple sites in North America, Europe, Africa and Asia.

• REC name

  HSC REC B

• REC reference

  23/NI/0059

• Date of REC Opinion

  7 Aug 2023

• REC opinion

  Further Information Favourable Opinion