A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age and Older (ARIES)
NCT07717840 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-07-21
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.
Conditions
- RSV Respiratory Syncytial Virus
Interventions
- BIOLOGICAL
-
AZD6489
Participants will receive AZD6489 as a single intramuscular injection.
- BIOLOGICAL
-
Licensed RSV vaccine #1
Participants will receive licensed RSV vaccine #1 as a single intramuscular injection.
- BIOLOGICAL
-
Licensed RSV vaccine #2
Participants will receive licensed RSV vaccine #2 as a single intramuscular injection.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-08
- Primary Completion
- 2026-10-15
- Completion
- 2027-09-06
- FDA Drug
- Yes
Countries
- United States
Study Locations
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