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Virus Vaccine
Influenza Vaccine for Coronavirus Prevention
Phase 3
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days after first vaccination on day 1 (up to day 8); 7 days after second vaccination on day 29 (up to day 36)
Awards & highlights
Study Summary
This trial is testing if a new vaccine for Covid-19 is non-inferior to the current flu vaccine, and if the new vaccine has an inferior binding antibody response when administered alone.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days after first vaccination on day 1 (up to day 8); 7 days after second vaccination on day 29 (up to day 36)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after first vaccination on day 1 (up to day 8); 7 days after second vaccination on day 29 (up to day 36)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine
Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine
Secondary outcome measures
GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants
Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine
Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine
+9 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and PlaceboExperimental Treatment3 Interventions
Participants aged >=65 years will receive a single IM injection of Ad26.COV2.S and a seasonal Q HD influenza vaccine on Day 1 followed by placebo on Day 29.
Group II: Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and PlaceboExperimental Treatment3 Interventions
Participants aged greater than or equal to (>=) 18 years will receive a single intramuscular (IM) injection of Ad26.COV2.S and a seasonal Q SD influenza vaccine on Day 1 and placebo on Day 29.
Group III: Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.SPlacebo Group3 Interventions
Participants aged >=18 years will receive a single IM injection of placebo and a seasonal Q SD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29.
Group IV: Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.SPlacebo Group3 Interventions
Participants aged >=65 years will receive a single IM injection of placebo and a seasonal Q HD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza Vaccine
2010
Completed Phase 4
~6900
Ad26.COV2.S
2021
Completed Phase 3
~84050
Find a Location
Who is running the clinical trial?
Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,133,487 Total Patients Enrolled
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
134,695 Total Patients Enrolled
Frequently Asked Questions
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