A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age
NCT05903183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264
Last updated 2025-12-05
Summary
The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 85 years of age.
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
IVX-A12
IVX-A12 without adjuvant
- BIOLOGICAL
-
IVX-A12
IVX-A12 with adjuvant
- BIOLOGICAL
-
Diluent
Sponsors & Collaborators
-
Icosavax, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-15
- Primary Completion
- 2023-06-05
- Completion
- 2024-10-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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