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

Completed · Phase 3 · Has a placebo group

Conditions studied: Influenza, Human Prevention, Respiratory Syncytial Viruses Prevention

In brief

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.

Key facts

Study ID

NCT05071313

Run by

Janssen Vaccines & Prevention B.V.

People needed

777

Starts

2021-10-04

Expected to finish

2022-10-11

Last updated by the study team

2025-05-25

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to adhere to the prohibitions and restrictions specified in this protocol
• In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Participants will be included on the basis of medical history and vital signs performed between informed consent from (ICF) signature and vaccination
• Before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile
• From the time of vaccination through 3 months after vaccination, agrees not to donate blood
• Must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
• Participant must be able to work with smartphones/tablets/computers

You may not qualify if…

• History of malignancy within 5 years before screening not in the following categories: a) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgement, can be enrolled
• Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
• History of severe allergic reactions (example, anaphylaxis) to any component of the Quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
• Has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination
• Per medical history, participant has chronic active hepatitis B or hepatitis C infection
• History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
• Has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
• Received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere

Where it is running

• Ark Clinical Research — Long Beach, California, United States
• Research Centers of America, LLC — Hollywood, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Synexus Clinical Research US Inc — The Villages, Florida, United States
• Synexus Clinical Research US Inc — Chicago, Illinois, United States
• Meridian Clinical Research, LLC — Rockville, Maryland, United States
• Sundance Clinical Research — St Louis, Missouri, United States
• Synexus Clinical Research US Inc — St Louis, Missouri, United States
• Meridian Clinical Research, LLC — Grand Island, Nebraska, United States
• Meridian Clinical Research, LLC — Lincoln, Nebraska, United States
• Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
• Meridian Clinical Research, LLC — Omaha, Nebraska, United States
• Tekton Research Inc. — Yukon, Oklahoma, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• VitaLink Research Spartanburg — Spartanburg, South Carolina, United States
• AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company — Knoxville, Tennessee, United States
• Optimal Research — Austin, Texas, United States
• Tekton Research Inc. — Austin, Texas, United States
• DM Clinical Research — Tomball, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.