Study identifier:ICVX-12-201
ClinicalTrials.gov identifier:NCT05903183
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 2a Randomized, Observer-blind, Placebo-controlled, Dosage Optimization, Multi-center Clinical Trial to Evaluate the Safety and Immunogenicity of IVX-A12, a Respiratory Syncytial Virus and Human Metapneumovirus Bivalent Combination Virus-like Particle Protein Subunit Vaccine, in Adults 60 to 85 Years of Age
Healthy
Phase 2
Yes
-
All
264
Interventional
60 Years - 85 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Other
Verified 01 Nov 2025 by Icosavax, Inc.
Icosavax, Inc.
-
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: IVX-A12 Vaccine Formulation 1 Participants will receive a single dose of IVX-A12 intramuscular (IM) injection on Day 0. | Biological/Vaccine: IVX-A12 IVX-A12 without adjuvant |
| Experimental: IVX-A12 Vaccine Formulation 2 Participants will receive a single dose of IVX-A12 IM injection on Day 0. | Biological/Vaccine: IVX-A12 IVX-A12 with adjuvant |
| Placebo Comparator: Placebo Participants will receive a single dose of placebo IM injection on Day 0. | Biological/Vaccine: Placebo Diluent |