MedTrace Logo

A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea

NCT06593587 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2026-02-09

Study results available
· View outcomes & findings →

Summary

The goal of this clinical trial is to quantify the immune response in older Korean adults after a RSVpreF vaccination. It will also learn about the safety and tolerability of RSVpreF vaccination. The main questions it aims to answer are:

What local reactions and systemic events do participants have after a RSVpreF vaccination? What medical problems do participants have after a RSVpreF vaccination? Researchers will compare RSVpreF to a placebo (a look-alike substance that contains no RSVpreF) to see if RSVpreF is safe and well tolerated. It will also examine the change in antibody levels (immune responses) before and after vaccination.

Participants will:

Receive the RSVpreF vaccination or a placebo injection once at Visit 1. Visit the clinic a month later for a checkup and tests. Receive a phone call 1 week after vaccination, and 2 months after vaccination, for health checks.

Keep a diary of their symptoms for 7 days after vaccination.

Conditions

Interventions

BIOLOGICAL

RSVpreF Vaccine

RSV Vaccine 120 mcg

OTHER

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-07
Primary Completion
2025-02-03
Completion
2025-02-03
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases
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 NCT06593587 on ClinicalTrials.gov