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Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older Adults

NCT05879107 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1113

Last updated 2025-05-18

Study results available
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Summary

The purpose of this study is to assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with PCV20 and its safety in older adults, aged ≥60 years of age.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSVPreF3 OA investigational vaccine

One dose of RSVPreF3 OA vaccine given intramuscularly in participant's non-dominant arm on Day 1 (in the Coad group) or Day 31(in the Control group).

BIOLOGICAL

PCV20

One dose of the 20-valent pneumococcal conjugate vaccine (PCV20) given intramuscularly in participant's dominant arm (Coad group) or non-dominant arm (Control group) on Day 1

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2023-12-06
Completion
2024-05-07
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Poland
  • 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 NCT05879107 on ClinicalTrials.gov