Investigator: Peter Richmond
Project description
Respiratory syncytial virus (RSV) is a common, highly contagious virus that causes infections of the lungs and respiratory tract. In most adults and older, healthy children, RSV symptoms are mild. It can, however, cause severe infection in some people, especially premature babies, older adults and infants. This study assesses the investigational RSV vaccine RSVpreF, administered to healthy pregnant women. The study aims to see whether RSVpreF vaccination is effective in protecting infants from RSV, and to see how safe and well tolerated the vaccine is in pregnant women and their infants. Healthy pregnant women will be randomised 1:1 to receive a single injection of RSVpreF vaccine or placebo. Study vaccine administration will be timed such that participants' infants are likely to be exposed to RSV in the first 6 months of life. Safety, tolerability and immune response will be assessed in participating mothers. Infants will have safety assessments, and antibodies transferred from mother to infant will be measured. Infants will be monitored for signs of acute respiratory illness for approximately 12 - 24 months from birth (depending on when they are enrolled into the study).
Funders of the project
- Pfizer