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A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

NCT05921903 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2026-05-11

Study results available
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Summary

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSVPreF3 OA Investigational Vaccine

0.5 mililiter dose was administered intramuscularly as 1 dose to RSV\_IC\_1 and RSV\_HA groups, and 2 doses to RSV\_IC\_2 group.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-28
Primary Completion
2024-06-25
Completion
2025-05-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Italy
  • Japan
  • South Korea
  • Spain

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 NCT05921903 on ClinicalTrials.gov