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Cancer Vaccine

Cohort 2 Arm D: COVID-19 vaccine and licensed influenza vaccine concomitant administration group for COVID-19

Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7
Awards & highlights
Pivotal Trial

Study 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.

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 A recipients compared to licensed influenza vaccine recipients 4 weeks after vaccination
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 A recipients compared to participants having received licensed influenza vaccine and COVID-19 concomitant administration group at 4 weeks after vaccination
+9 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: 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 II: 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 III: 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
Group IV: 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
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
63 Previous Clinical Trials
99,499 Total Patients Enrolled
20 Trials studying COVID-19
89,659 Patients Enrolled for COVID-19
PfizerIndustry Sponsor
4,545 Previous Clinical Trials
11,413,828 Total Patients Enrolled
66 Trials studying COVID-19
1,430,008 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,457 Previous Clinical Trials
8,595,298 Total Patients Enrolled
48 Trials studying COVID-19
1,418,785 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the level of safety observed in Cohort 1 Arm B, which involves administering both a licensed influenza vaccine and COVID-19 vaccine simultaneously to individuals?

"Based on our assessment at Power, the safety level of Cohort 1 Arm B, which involves administering a licensed influenza vaccine and COVID-19 concurrently, is ranked as 3. This ranking is supported by the fact that this trial belongs to Phase 3, indicating existing evidence supporting efficacy and multiple rounds of data confirming its safety."

Answered by AI

Is the enrollment process open for this medical study at present?

"As per the information provided on clinicaltrials.gov, this particular clinical trial is not presently accepting new participants. The study was initially posted on December 21st, 2023 and last modified on December 20th, 2023. However, it's worth noting that there are currently 781 other ongoing studies actively recruiting patients at this time."

Answered by AI

Are there numerous medical facilities in North America currently conducting this clinical trial?

"Velocity Clinical Research, Westlake in Los Angeles, California; Pharmaron in Baltimore, Maryland; and Health Research of Hampton Roads, Inc. in Newport News, Virginia are among the 118 additional locations where this clinical trial is being conducted."

Answered by AI

Is the inclusion criteria for this research limited to individuals who have surpassed their 18th year of age?

"To be eligible for participation in this clinical trial, individuals must fall within the age range of 18 to 64. It is worth noting that there are a total of 122 ongoing trials available specifically for participants under the age of 18, and an additional 649 trials targeting individuals over the age of 65."

Answered by AI

Who else is applying?

What site did they apply to?
Accel Research Sites Network - Birmingham Clinical Research Unit
HOPE Research Institute
Santa Clara Family Clinic
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Protection due to age. I'm willing to make a change. I believe in science and medicine and helping to further medical research.
PatientReceived 2+ prior treatments
I need the Covid 19 Study because a family member told me about it.l need the vaccine.
PatientReceived no prior treatments
I haven't taken flu shot this year, last COVID-19 booster was taken 7 months ago, it's time to take both of them. Additionally, I'd like to contribute to the medical research.
PatientReceived 2+ prior treatments
~6000 spots leftby Aug 2024