A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Icosavax, Inc.
Study ID
NCT05903183
Phase
PHASE2
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • IVX-A12 — BIOLOGICAL
    IVX-A12 without adjuvant
  • IVX-A12 — BIOLOGICAL
    IVX-A12 with adjuvant
  • Placebo — BIOLOGICAL
    Diluent

Study Details

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.

Key Dates

First listed
Jun 15, 2023
Start date
May 15, 2023
Status verified
Nov 2025
Primary completion
Jun 5, 2023
Completion
Oct 25, 2024

Study Design

Enrollment
264 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: IVX-A12 Vaccine Formulation 1
    Participants will receive a single dose of IVX-A12 intramuscular (IM) injection on Day 0.
  • Experimental: IVX-A12 Vaccine Formulation 2
    Participants will receive a single dose of IVX-A12 IM injection on Day 0.
  • Placebo Comparator: Placebo
    Participants will receive a single dose of placebo IM injection on Day 0.

Primary Outcome Measure

Number of Participants With Solicited Local Adverse Reactions (ARs) and Systemic ARs [ Time Frame: From Day 0 to Day 6 ]

Locations (10)

FacilityCityStateZIPSite coordinators
AMR PhoenixTempeArizona85281-
Cenexel RCAHollywoodFlorida33024-
Clinical Research AtlantaStockbridgeGeorgia30281-
Velocity Clinical Research-BoiseMeridianIdaho83642-
ASR, LLCNampaIdaho83587-
Johnson City Clin-Trials (JCCT)LenexaKansas66219-
AMR LexingtonLexingtonKentucky40509-
Velocity Clinical ResearchOmahaNebraska68134-
Rochester Clinical Research, IncRochesterNew York14609-
PanAmerican Clinical ResearchBrownsvilleTexas78520-

Find similar trials in Tempe, AZ

By research site
AMR Phoenix· Tempe, AZCenexel RCA· Hollywood, FLClinical Research Atlanta· Stockbridge, GAVelocity Clinical Research-Boise· Meridian, IDASR, LLC· Nampa, IDJohnson City Clin-Trials (JCCT)· Lenexa, KS

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