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Cancer Vaccine
Combined Vaccine for COVID-19 and Flu
Phase 3
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants 18 through 64 years of age (or the minimum age of consent in accordance with local regulations) at Visit 1
Be between 18 and 65 years old
Must not have
Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after vaccination
Awards & highlights
Pivotal Trial
Summary
This trial is studying the safety and effects of a combined influenza and COVID-19 vaccine. The goal is to see if giving both vaccines at the same time can provide better protection against both diseases. Around
Who is the study for?
This trial is for healthy adults aged 18-64 who haven't had any flu or COVID-19 vaccines in the past 6 months. They must pass a medical review and possibly a physical exam to join.
What is being tested?
The study tests a combined vaccine for influenza and COVID-19 against separate vaccinations for each virus. Participants are randomly placed into one of four groups, receiving either combined or individual vaccines.
What are the potential side effects?
Potential side effects may include typical reactions like soreness at the injection site, fever, fatigue, headache, muscle pain similar to those experienced with regular flu and COVID-19 vaccines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had a flu shot or taken flu antiviral drugs in the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 3 Arm E:Influenza and COVID-19 Combination BExperimental Treatment1 Intervention
Cohort 3 Arm E:Influenza and COVID-19 Combination B
Group II: Cohort 2 Arm C:Influenza and COVID-19 Combination B and PlaceboExperimental Treatment2 Interventions
Cohort 2 Arm C: Influenza and COVID-19 Combination B vaccine and Placebo
Group III: Cohort 1 Arm A: Influenza and COVID-19 Combination A and PlaceboExperimental Treatment2 Interventions
Cohort 1 Arm A: Influenza and COVID-19 combination A vaccine and Placebo
Group IV: Cohort 3 Arm F: COVID-19 vaccineActive Control1 Intervention
Cohort 3 Arm F: COVID-19 vaccine
Group V: Cohort 3 Arm G: Licensed influenza vaccineActive Control1 Intervention
Cohort 3 Arm G: Licensed influenza vaccine
Group VI: Cohort 3 Arm H: Investigational influenza vaccineActive Control1 Intervention
Cohort 3 Arm H: Investigational influenza vaccine
Group VII: Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration groupActive Control2 Interventions
Cohort 1 Arm B: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Group VIII: Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration groupActive Control2 Interventions
Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
BioNTech SELead Sponsor
77 Previous Clinical Trials
107,024 Total Patients Enrolled
PfizerIndustry Sponsor
4,669 Previous Clinical Trials
17,853,044 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,894,085 Total Patients Enrolled