What is RSV?
- Enveloped single-strand RNA pneumovirus within the Paramyxoviridae family
– 2 main subgroups: A/B – antigenically related
- In temperate climates, annual epidemics occur during winter
- Circulation overlaps with seasonal influenza
Most common cause of ALRI in children <5 years, and a major cause of ALRI-associated hospitalisation
Who is most at risk of RSV?
- Almost all children will have experienced an RSV infection by 2 years of age
- Very young infants have the greatest risk of severe illness caused by RSV
- The highest priority target population is the RSV-naïve child
There is currently no specific treatment or currently approved vaccine. The development of effective new vaccines … to tackle RSV have the potential to make major contributions to reducing severe disease and deaths from RSV in children globally.
What is GRACE study?
- Phase 3 Global Clinical study
- Approximately 10,000 pregnant women
- Double-blind study
- Single dose administered intramuscularly
- Robust safety data is available from prior studies
What is the Purpose of the study?
- Evaluate the ability of the vaccine in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers.
- Evaluate the safety and immunogenicity of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.