NCT06481579

A Study of IVX-A12 in Adults Participants

A Phase 2, Randomized, Modified Double-Blind, Active Controlled Study to Characterize the Safety and Immunogenicity of IVX-A12 in Adults 60 Years of Age and Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Icosavax, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the immunogenicity and safety of IVX-A12 in adults 60 years of age and older.

Detailed description

This is a randomized, modified double-blind, active controlled study to characterize the immunogenicity and safety of IVX-A12. Approximately 140 participants will be randomized in a 1:1 ratio to receive IVX-A12 (approximately 70) or licensed respiratory syncytial virus (RSV) vaccine (AREXVY) (approximately 70). The study is planned to be conducted at approximately 5 sites in the United States. The duration of each participant's involvement in the study will be approximately 6 months following administration of study vaccination.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
BIOLOGICAL	IVX-A12	IVX-A12 IM injection.
BIOLOGICAL	Licensed RSV Vaccine	Licensed RSV Vaccine (AREXVY) IM injection.

Timeline

• Start date: 2024-06-10
• Primary completion: 2024-07-17
• Completion: 2024-12-19
• First posted: 2024-07-01
• Last updated: 2025-08-26
• Results posted: 2025-08-26

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study