A Phase I/II, Randomized, Double-Blind, Active-Controlled Study to Characterize the Safety and Immunogenicity of AZD6489 in Adults 60 Years of Age and Older
AstraZeneca
Summary
This Phase I/II study is to characterize the safety and immunogenicity of 2 dose levels of AZD6489, an investigational RSV recombinant prefusion F protein VLP vaccine.
Description
This Phase I/II clinical study will be conducted in the US at approximately 5 sites. The study is a randomized, double-blind, active-controlled study to characterize the safety and immunogenicity of a single dose of AZD6489 in adults ≥ 60 years of age. Two dose levels of AZD6489 will be assessed. Approximately 160 participants will be randomized and stratified by age group and previous receipt of RSV vaccine. Participants will be randomized/dosed to receive AZD6489, licensed RSV vaccine #1, or licensed RSV vaccine #2. The study is split into 2 cohorts based on the 2 dose levels of AZD6489 bei…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- Yes