Safety and Efficacy Trial of MK-1654 in Healthy Infants

• Research type

  Research Study

• Full title

  A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

• IRAS ID

  1003657

• Contact name

  Debbie Walton

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2020-002405-26

• Clinicaltrials.gov Identifier

  NCT04767373

• Research summary

  Respiratory syncytial virus (RSV) is a common respiratory virus. It can cause cold-like symptoms, such as a runny nose, fever, and cough. Both adults and children can get RSV. Most healthy adults recover quickly from the virus. Sometimes, RSV causes serious health issues in infants, such as breathing problems, high fever, and infections of the lungs. Currently, there are no treatments available in the UK to prevent RSV for healthy infants. Mortality from RSV infection is significant, with an estimated 94,600 to 149,400 childhood deaths worldwide.

  This study is testing a potential medicine (MK-1654) for infants to see if it may help prevent lower respiratory infections caused by RSV. The study medicine has not yet been approved.
  This clinical study will help researchers understand if this treatment may help prevent RSV infection
  in infants. Researchers will see how well the study medicine works, whether the treatment is safe, and how well infants’ bodies tolerate the treatment.

  The study will evaluate MK-1654 compared to a placebo (the placebo looks like the study medicine but has no active medicine) for the prevention of RSV respiratory infections in healthy pre-term and full-term infants.

  Overall 3300 healthy male and female infants from birth up to 8 months and 29 days of age and entering their first RSV season will be randomised into a 2:1 ratio to receive a single dose of MK-1654 or placebo and will be followed for either 365 days or 515 days. Some infants will be in this trial for about 12 months and visit the trial site about 7 times. Others will be in the trial for about 18 months and visit the trial site about 8 times. The Sponsor estimates that the study will run for approximately 3.5 years.

  The study is funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (“MSD”) of Kenilworth, New Jersey, USA and will take place at 7 NHS Sites in the UK.
  Lay Summary of Results:
  https://clinicaltrials.gov/study/NCT04767373?term=1654-004&rank=1&tab=results
  

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  21/SC/0149

• Date of REC Opinion

  18 Jun 2021

• REC opinion

  Further Information Favourable Opinion