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Cancer Vaccine

mRNA COVID-19 + Influenza Vaccinations for Flu and Coronavirus

Phase 4
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy children aged 6-11 years and healthy adults aged 18-64 years that have not received the current season's influenza vaccination or a mRNA COVID-19 vaccination in the past 6 months and have already completed at least a two-dose primary series of an mRNA COVID-19 vaccination
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (baseline), visit 2 (day 28), and visit 3 (day 56)
Awards & highlights

Study Summary

This trial looks at how well the flu and COVID-19 vaccines work in people of different ages.

Who is the study for?
This trial is for healthy children aged 6-11 and adults 18-64 who haven't had the current season's flu shot or a COVID mRNA booster in the last 6 months, but have completed their initial COVID vaccine series. Participants must be able to attend all study visits, speak English or Spanish, and not plan on pregnancy within three months.Check my eligibility
What is being tested?
The study is testing how well people respond to getting their flu shot and COVID mRNA booster either at the same time or one after the other. It's being done across four US sites to see if there's a difference in immune response with these different schedules.See study design
What are the potential side effects?
Possible side effects from vaccinations may include soreness at injection site, fever, fatigue, headache, muscle pain. Rarely severe allergic reactions can occur. Side effects typically vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy child (6-11) or adult (18-64), haven't had this season's flu shot or COVID-19 shot in 6 months, but completed the initial 2-dose COVID-19 series.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (baseline), visit 2 (day 28), and visit 3 (day 56)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (baseline), visit 2 (day 28), and visit 3 (day 56) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in influenza antibody titer as measured by hemagglutination inhibition (HAI)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group iiiExperimental Treatment1 Intervention
Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2
Group II: Group iiExperimental Treatment1 Intervention
Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2
Group III: Group iExperimental Treatment1 Intervention
Simultaneous Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,269 Total Patients Enrolled
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,476,602 Total Patients Enrolled
Senders PediatricsUNKNOWN

Frequently Asked Questions

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

Does this research encompass individuals of elderly age?

"The minimum age for inclusion in this trial is 6 years old and the cap has been set at 64."

Answered by AI

Who meets the criteria for eligibility in this clinical trial?

"Eligibility for this investigation requires that patients have contracted COVID-19 and are between 6 to 64 years of age. 800 volunteers will be recruited across the trial's duration."

Answered by AI

What health hazards has Group i been linked to for patients?

"Based on the Phase 4 status of Group i, our Power team placed its safety rating at 3 out of 3."

Answered by AI

Is this experimentation accepting participants at the moment?

"Based on the clinicaltrials.gov records, it appears that this particular research venture is no longer taking applications from participants. The trial was first publicized on September 15th 2023 and underwent its last edit two weeks later. However, 852 other trials are currently recruiting individuals to participate in their studies."

Answered by AI

How many local healthcare facilities are actively conducting this research endeavor?

"The ASU Biodesign Institute in Tempe, Georgia, Centers for Disease Control and Prevention in Atlanta, Missouri, and Washington University IDCRU in Saint Louis, Ohio are three of the eleven enrolment sites hosting this clinical trial."

Answered by AI

Who else is applying?

What site did they apply to?
Centers for Disease Control and Prevention
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
2023. "Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06020118.
All > Covid 19 > Influenza
~505 spots leftby Apr 2025
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