Palivizumab-controlled evaluation of MK-1654 in infants at increased risk for severe RSV

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

• IRAS ID

  1004762

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

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

• Eudract number

  2020-005996-11

• Clinicaltrials.gov Identifier

  NCT04938830

• Research summary

  Respiratory syncytial virus (RSV) is a common virus that can infect the lungs and air passages, such as the mouth, nose, and throat. Most children who get RSV have a mild cold. However, some children who get RSV may become more sick, such as children born before their expected due date or with certain heart and lung problems.
  
  This trial is testing MK-1654 in infants. It is being studied to see if it can prevent RSV infection in infants at higher risk of having severe RSV illness. This trial will compare MK-1654 to palivizumab. Palivizumab, also called SYNAGIS®, is an approved treatment to prevent severe RSV illness. MK-1654 is not an approved treatment and is considered experimental. Researchers are testing to see how well the study medicine works, whether the treatment is safe and how well infants’ bodies tolerate the treatment compared to palivizumab. They will also measure what happens as MK-1654 goes through the body.

  Overall, 1000 infants from birth up to 1 year of age and entering their first RSV season will be randomly assigned to receive either MK-1654 and placebo, or palivizumab by injection. They will be in the trial for about 1 year and will visit the trial site 6 to 8 times. Some children will also be eligible to participate for a second RSV season. They will receive a dose of MK-1654 at the start of the second RSV season and will be in the trial for about 18 months and will visit the site about 10 to 12 times. Visits to the trial site will include physical examinations, blood samples and may include nose swabs.

  The study is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (“MSD”) and will take place at 8 NHS Sites in the UK.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  22/WM/0066

• Date of REC Opinion

  28 Apr 2022

• REC opinion

  Further Information Favourable Opinion