MedTrace Logo

Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

NCT07734649 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2026-07-29

No results posted yet for this study

Summary

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.

The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups).

The duration of the study will be approximately 12 months for each participant.

Conditions

  • Respiratory Syncytial Virus Immunization
  • Human Metapneumovirus Immunization
  • Healthy Volunteers

Interventions

BIOLOGICAL

RSV+HMPV vaccine

RSV + HMPV Candidate Vaccine

BIOLOGICAL

Control Vaccine 3

Control Vaccine 3

BIOLOGICAL

Control Vaccine 4

Control Vaccine 4

BIOLOGICAL

Control Vaccine 2

Control Vaccine 2

OTHER

Placebo

Placebo

BIOLOGICAL

Control Vaccine 1

Control Vaccine 1

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-22
Primary Completion
2028-05-03
Completion
2028-05-03
FDA Drug
Yes

Countries

  • United States

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 NCT07734649 on ClinicalTrials.gov