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A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older

NCT05071313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 777

Last updated 2025-05-25

Study results available
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Summary

The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.

Conditions

  • Influenza, Human Prevention
  • Respiratory Syncytial Viruses Prevention

Interventions

BIOLOGICAL

Ad26.RSV.preF-based vaccine

Ad26.RSV.preF-based vaccine will be administered as single IM injection.

BIOLOGICAL

Quadrivalent High-dose Influenza Vaccine

Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.

BIOLOGICAL

Placebo

Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2022-04-20
Completion
2022-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05071313 on ClinicalTrials.gov