Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women
brief summary
A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age
detailed description
A Phase 1, randomized, blinded, active controlled clinical trial to evaluate the safety, tolerability and immunogenicity of a recombinant, stabilized pre-f respiratory syncytial virus (RSV) vaccine (MKK900), non-adjuvanted, in healthy women aged 18-49 years
Participants will be randomized in a 1:1:1 ratio to receive a single IM injection of one of low-dose MKK900, high-dose MKK900 or the active control (ABRYSVO).
Participants will be immunized on day 1 and safety and immunogenicity will be evaluated at day 8, 31 and 91. Safety will also be assessed at day 181.
official title
A Phase 1, Randomized, Blinded, Active Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant, Stabilized Pre-F Respiratory Syncytial Virus (RSV) Vaccine (MKK900), Non-adjuvanted, in Healthy Women Aged 18-49 Years