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Safety and Immunogenicity of IVX-A12 in Healthy Older Adults

NCT05664334 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-03-05

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the safety and immunogenicity of three dosage levels (low, medium, high) of the bivalent combination 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 75 years of age.

Conditions

  • Healthy

Interventions

BIOLOGICAL

IVX-121

75 mcg of IVX-121 without MF59®

BIOLOGICAL

IVX-241

75 mcg of IVX-241 without MF59®

BIOLOGICAL

Placebo

Diluent

BIOLOGICAL

IVX-121

75 mcg of IVX-121, without MF59®

BIOLOGICAL

IVX-241

150 mcg IVX-241, without MF59®

BIOLOGICAL

IVX-241

225 mcg of IVX-241, without MF59®

BIOLOGICAL

IVX-121

75 mcg of IVX-121, with MF59®

BIOLOGICAL

IVX-241

75 mcg of IVX-241, with MF59®

BIOLOGICAL

IVX-241

150 mcg IVX-241, with MF59®

OTHER

MF59®

MF59® as an adjuvant

Sponsors & Collaborators

  • Icosavax, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-01-24
Completion
2024-01-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05664334 on ClinicalTrials.gov