RSV MAT-009

• Research type

  Research Study

• Full title

  A Phase III, randomized, double-blind, placebo controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RSV Maternal vaccine, administered IM to pregnant women 18 to 49 years of age, for prevention of RSV associated LRTI in their infants up to 6 months of age

• IRAS ID

  288592

• Contact name

  Asma Khalil

• Contact email

  akhalil@sgul.ac.uk

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2020-001355-40

• Duration of Study in the UK

  2 years, 11 months, 19 days

• Research summary

  Respiratory Syncytial Virus (RSV) is a germ that can cause infections of the airways. Whilst most infections of RSV present as a simple cold, in young babies RSV can cause difficulty in breathing and can be dangerous. RSV infection is one of the most common reasons for young babies to be admitted to hospital.
  For protection against RSV, babies rely upon antibodies given to them from their mothers during pregnancy. A vaccine is one way to increase the antibodies in pregnant women.
  This study, funded by GlaxoSmithKline, will assess safety and efficacy of an RSV Maternal vaccine in pregnant women and their babies. It will check: how well the vaccine can boost antibodies in pregnant women; how well the antibodies are passed from the pregnant woman to their babies; how long its stays in the babies’ blood; if pregnant women visit a doctor less often for cold-like illnesses; and if the RSV caused the illness.
  The study will include around 10,000 participants worldwide. Six hospitals in the UK will take part.
  Women aged 18 to 49 years, between weeks 24 and 34 of uncomplicated pregnancies will be included.
  Mothers will have: up to 5 study visits; receive a single dose of active vaccine or placebo (a dummy vaccine); general and obstetrical examinations; heath questions; blood collected from their arm and umbilical cord; monthly contacts; and will be followed for 6 months after delivery.
  Babies will have: 5 planned visits; a physical examination; health questions; at least one monthly contact; blood collected if umbilical cord could not be collected. Approximately 1,500 infants will have one blood sample taken. All babies will be followed for 12 months after birth.
  Safety will be monitored for mothers and babies. They may have extra visits for cold-like illnesses, where nasal swabs will be collected.

  Summary of Results
  A lay summary of the results has been included on https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fgsk.trialsummaries.com%252FStudy%252FStudyDetails%253Fid%253D11518%2526tenant%253DMT_GSK_9011%2FNBTI%2FxXu3AQ%2FAQ%2F37b61d30-162c-4c57-b3fc-9939a102cd77%2F1%2F2GwcC9Gzd0&data=05%7C02%7Cberkshire.rec%40hra.nhs.uk%7C4a10ad88dd4c44915f0908dcc1c0e5db%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638598281438565559%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=RBzyVa2ZE7GrnxpyqUQiTuRItc%2BzAL6CdgeRdp0YNrc%3D&reserved=0

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  20/SC/0419

• Date of REC Opinion

  13 Jan 2021

• REC opinion

  Further Information Favourable Opinion