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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 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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after first vaccination on day 1 (up to day 8); 7 days after second vaccination on day 29 (up to day 36) for reporting.

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 more

Trial 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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~252 spots leftby Apr 2025