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Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults

NCT07295028 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-20

No results posted yet for this study

Summary

This study is being done to find out how safe and effective a new combined vaccine candidate, called VXB-251, is for older adults. The vaccine candidate is designed to protect against three common viruses that can cause respiratory tract infections:

* RSV (respiratory syncytial virus)
* hMPV (human metapneumovirus)
* PIV3 (parainfluenza virus type 3)

Two components of this vaccine (RSV and hMPV) have already been tested in people before, as part of another study for a two-in-one vaccine. However, this is the first time that the PIV3 component and all three components together (RSV, hMPV, and PIV3) are being tested in people.

The vaccine candidate will be given as a single intramuscular injection. The study will also test unlicensed comparator vaccines and a placebo (a substance that looks like the real vaccine but doesn't contain any active ingredients) that target none, one or two of these viruses to see whether combining all three components affects safety or how well the immune system responds.

Conditions

  • Lower Respiratory Tract Disease
  • Healthy Participants

Interventions

BIOLOGICAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

VXB-251 low dose, single, IM injection.

BIOLOGICAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

VXB-251 medium dose, single, IM injection.

BIOLOGICAL

trivalent (RSV/hMPV/PIV3) vaccine candidate

VXB-251 high dose, single, IM injection.

BIOLOGICAL

bivalent (RSV/hMPV) unlicensed comparator

VXB-241 medium dose, single, IM injection.

BIOLOGICAL

monovalent (RSV) unlicensed comparator

VXB-213 medium dose, single, IM injection.

BIOLOGICAL

Biological/Vaccine: monovalent (hMPV) unlicensed comparator

VXB-221 medium dose, single, IM injection.

BIOLOGICAL

monovalent (PIV3) unlicensed comparator

VXB-232 medium dose, single, IM injection.

OTHER

Placebo

diluent, single, IM injection.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2026-04-21
Completion
2027-04-24

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

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 NCT07295028 on ClinicalTrials.gov