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A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminium in Healthy Third-trimester Pregnant Women; and Safety

Investigators: Elke Seppanen, Fiona McDonald, Glady Perez, Jan Jones, Jennifer Kent, Lisa Montgomery, Peter Richmond

Project description

RSV, or Respiratory Syncytial Virus, is a virus that infects the airways and lungs. RSV is similar to the viruses that cause the flu or the common cold, RSV causes symptoms such as runny nose, cough and trouble breathing, and is extremely common. Almost every infant is exposed to RSV by the age of 2. Many children experience mild symptoms that are mistaken for the common cold and get better without treatment. Newborn babies 0-6 months of age can develop more severe complications such as bronchiolitis (inflammation of the small airways in the lungs) or pneumonia and may require hospitalisation due to the infant not being able to feed or requiring oxygen.

The Maternal RSV Vaccine Study aims to determine whether an RSV vaccine given to pregnant women during the third trimester can protect newborn babies from RSV infections. Similar clinical studies have given investigational vaccines to pregnant women and have been proven to protect newborn babies against tetanus, pertussis (whooping cough) and influenza. To help determine if the vaccine is effective against RSV some pregnant women will receive the RSV vaccine and others will receive a placebo vaccine.

This is an international study that commenced in 2016 aiming to enroll 8618 pregnant women whose infants will be born during the winter months, when RSV is most prevalent. To end December 2017, over 3,000 women have enrolled internationally including 25 from the Perth site.

Partners

  • Novavax Inc.