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Oxford University Hospitals NHS Foundation Trust

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A Study to see if a new experimental medicine (MEDI8897) is safe and effective in preventing Respiratory Syncytial Virus in healthy preterm infants

Trial categories: Immunity; Infection; Vaccines

Sponsoring organisation: MedImmune LLC

A Phase 2b Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus in Healthy Preterm Infants

RSV is a virus that is present in the general population from late autumn to early spring. Infection with RSV is very common in children. In the first year of life, about half of all infants become infected with RSV. RSV typically causes a cold-like illness in older children and adults, but can cause serious lung disease in infants and young children which may require medical attention such as outpatient and emergency department visits or hospitalisation. Preterm infants are at high risk for having serious illness from RSV infection.

The Oxford Vaccine Group is taking part in a study of a new medicine to see whether it protects healthy preterm babies from RSV infection. The study sponsor, MedImmune, is developing a new medicine (MEDI8897) to protect infants from getting serious lower respiratory tract infection caused by RSV. MEDI8897 is an 'experimental medicine', meaning that it is not yet licensed for use by any authority that regulates new medicines.

The purpose of this study is to evaluate how effective MEDI8897 is at preventing lung disease caused by RSV and to evaluate the safety and tolerability of MEDI8897 in healthy preterm infants compared with placebo (a saline solution that looks like the study drug but does not contain any active ingredient).

If you are interested in your child taking part, or would like more information about the study, please contact us on:

Tel: 01865 857679

or

Email: sheula.barlow@paediatrics.ox.ac.uk or sharon.baugh@paediatrics.ox.ac.uk

A member of the study team will contact you to provide further information and answer any queries that you have.

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