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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 day 7
Awards & highlights

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.Check my eligibility
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.See study design
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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMR of HAI titers in Influenza and COVID-19 combination B recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination
GMR of SARS-CoV-2-neutralizing titers in Influenza and COVID-19 combination B recipients compared to participants having received licensed influenza vaccine concurrently in the deltoid opposite to that used for COVID-19 at 4 weeks after vaccination
Percentage of participants reporting adverse events (AEs) through 4 weeks following investigational product administration
+5 more
Secondary outcome measures
Difference in percentage of participants with seroconversion at 4 weeks after vaccination in influenza and COVID-19 combination B recipients compared to licensed influenza vaccine administered concomitantly with COVID-19 vaccine recipients
GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine alone
GMR of HAI titers at 4 weeks after vaccination in participants who received influenza and COVID-19 combination B to those who received licensed influenza vaccine concomitantly with COVID-19 vaccine
+2 more

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
69 Previous Clinical Trials
100,968 Total Patients Enrolled
20 Trials studying COVID-19
89,590 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,861,636 Total Patients Enrolled
67 Trials studying COVID-19
1,429,905 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,038,245 Total Patients Enrolled
50 Trials studying COVID-19
1,418,706 Patients Enrolled for COVID-19
~2140 spots leftby Nov 2024
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