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

PHASE3CompletedINTERVENTIONAL
Enrollment

777

Participants

Timeline

Start Date

October 4, 2021

Primary Completion Date

April 20, 2022

Study Completion Date

October 11, 2022

Conditions
Influenza, Human PreventionRespiratory 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.

Trial Locations (19)

20854

Meridian Clinical Research, LLC, Rockville

29303

VitaLink Research Spartanburg, Spartanburg

29405

Coastal Carolina Research Center, North Charleston

32127

Progressive Medical Research, Port Orange

32162

Synexus Clinical Research US Inc, The Villages

33024

Research Centers of America, LLC, Hollywood

37920

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company, Knoxville

60602

Synexus Clinical Research US Inc, Chicago

63141

Sundance Clinical Research, St Louis

Synexus Clinical Research US Inc, St Louis

68134

Meridian Clinical Research, LLC, Omaha

68510

Meridian Clinical Research, LLC, Lincoln

68701

Meridian Clinical Research, LLC, Norfolk

68803

Meridian Clinical Research, LLC, Grand Island

73099

Tekton Research Inc., Yukon

77375

DM Clinical Research, Tomball

78705

Optimal Research, Austin

78745

Tekton Research Inc., Austin

90806

Ark Clinical Research, Long Beach

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT05071313 - 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 | Biotech Hunter | Biotech Hunter