A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19 Prevention

In brief

The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.

Key facts

Study ID: NCT05091307
Run by: Janssen Vaccines & Prevention B.V.
People needed: 861
Starts: 2021-11-02
Expected to finish: 2022-11-15
Last updated by the study team: 2025-05-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participants may have underlying illnesses, as long as the symptoms and signs are medically controlled
Participant either received complete primary vaccination with an authorized/licensed coronavirus disease-2019 (COVID-19) vaccine (completed greater than or equal to [>=] 6 months prior to the last vaccination received against COVID-19) or is COVID-19 vaccine-naive
All participants who were born female and are of childbearing potential must: a. Have a negative highly sensitive urine pregnancy test at screening, b. Have a negative highly sensitive urine pregnancy test on the day of vaccination prior to each study vaccine administration
Participant agrees to not donate or receive bone marrow, blood, and blood products from the administration of the study vaccine until 3 months after receiving the study vaccines
Participant must be willing to provide verifiable identification to be contacted and to contact the investigator during the study

You may not qualify if…

Participant has a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancies considered cured with minimal risk of recurrence per investigator's clinical judgment)
Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degrees celsius (ºC) (100.4 degrees fahrenheit [°F]) within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator
Participant has history of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
Participant has history of capillary leak syndrome
Participant received a licensed/registered severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) vaccine less than 6 months prior to first study vaccination (other than study vaccination)
Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood

Where it is running

Fiel Family and Sports Medicine Clinical Research Advantage — Tempe, Arizona, United States
Wr McCr Llc — San Diego, California, United States
Clinical Research of South Florida, an AMR Company — Coral Gables, Florida, United States
AMR Fort Myers Clinical Physiology Associates, an AMR company — Fort Myers, Florida, United States
Office of Emilio Mantero-Atienza, MD — Miami, Florida, United States
University of Miami Health System — Miami, Florida, United States
Premier Research Associate, Inc — Miami, Florida, United States
Medisphere Medical Research Center, Llc — Evansville, Indiana, United States
Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
Clinical Research Consortium, an AMR company — Las Vegas, Nevada, United States
I.D. Care, Inc. — Hillsborough, New Jersey, United States
Rochester Clinical Research, Inc — Rochester, New York, United States
Carolina Institute for Clinical Research — Fayetteville, North Carolina, United States
Coastal Carolina Research Center — North Charleston, South Carolina, United States
Ventavia Research Group, LLC — Keller, Texas, United States
Research Your Health — Plano, Texas, United States
Clinical Research Partners, LLC — Richmond, Virginia, United States
Anima — Alken, Belgium
Institute of Tropical Medicine Antwerp — Antwerp, Belgium
Clinical Pharmacology Unit — Merksem, Belgium
Private Practice RESPISOM Namur — Namur, Belgium
Synexus Polska Sp. z o.o. Oddzial w Czestochowie — Częstochowa, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku — Gdansk, Poland
Gdanskie Centrum Zdrowia — Gdansk, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdynia — Gdynia, Poland

Full record on ClinicalTrials.gov

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