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A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone or Co-administered With an Adjuvanted Vaccine Against Influenza in Adults Aged 65 Years and Above

NCT05568797 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1045

Last updated 2024-09-24

Study results available
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Summary

The aim of this study is to assess the immunogenicity, safety and reactogenicity of the RSV PreFusion protein 3 older adult (RSVPreF3 OA) investigational vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU aQIV) vaccine, in adults aged 65 years of age (YOA).

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSVPreF3 OA vaccine

One dose of RSVPreF3 OA vaccine administered intramuscularly.

BIOLOGICAL

FLU vaccine

One dose of FLU vaccine administered intramuscularly.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2023-02-17
Completion
2023-07-17
FDA Drug
Yes

Countries

  • Belgium
  • Finland
  • France
  • Spain
  • United Kingdom

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 NCT05568797 on ClinicalTrials.gov