← Back to Search

Vaccine

Sequential Vaccination Group for Injection Site Reaction

Phase 4
Waitlist Available
Led By Emmanuel B Walter, MD, MPH
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days post vaccination (combined for visits 1 and 2)
Awards & highlights

Study Summary

This trial is testing whether it is better to get the flu vaccine and the Covid vaccine at the same time, or 14 days apart. They will also test different schedules for the Covid vaccine.

Eligible Conditions
  • Injection Site Reaction
  • Systemic Reaction
  • Quality of Life
  • Adverse Drug Reactions

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days post vaccination (combined for visits 1 and 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days post vaccination (combined for visits 1 and 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Group and the Sequential Group Following Both Vaccination Visit 1 and 2
Secondary outcome measures
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus Sequential Group Following the Second Vaccination Visit
Number of Participants With Moderate or More Severe Fever, Chills, Myalgia, or Arthralgia in the Simultaneous Versus the Sequential Group Following the First Vaccination Visit
Number of Participants With Observed Serious Adverse Events
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Simultaneous Vaccination GroupExperimental Treatment3 Interventions
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and IIV4 at Visit 1, saline placebo at Visit 2, and mRNA COVID-19 vaccine at Visit 3 (only for participants receiving their primary series of mRNA COVID-19 vaccine.)
Group II: Sequential Vaccination GroupExperimental Treatment3 Interventions
Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and saline placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 (only for participants receiving their primary series of mRNA COVID-19 vaccine.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA COVID-19
2021
Completed Phase 4
~350
IIV4
2020
Completed Phase 4
~1620

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,721 Total Patients Enrolled
3 Trials studying Injection Site Reaction
1,323 Patients Enrolled for Injection Site Reaction
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,477,054 Total Patients Enrolled
3 Trials studying Injection Site Reaction
1,323 Patients Enrolled for Injection Site Reaction
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,248 Total Patients Enrolled
2 Trials studying Injection Site Reaction
1,056 Patients Enrolled for Injection Site Reaction

Frequently Asked Questions

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

Has the Food and Drug Administration given its seal of approval to this technique?

"There is an abundance of clinical data backing the safety of this medication, thus it has been assigned a rating of 3 on our scale. This treatment was granted approval following Phase 4 trials."

Answered by AI

How many participants have signed up to take part in this investigation?

"In order to meet the study's objectives, 450 eligible participants are needed. The research sites offering this trial include John Hopkins University in Baltimore and Duke University of Durham."

Answered by AI

Are any individuals currently being admitted to this experiment?

"Positive. According to clinicaltrials.gov, this trial is still recruiting and was initially posted on October 4th 2021 with the last update being made September 12th 2022. 450 patients need to be signed up from 3 different medical centres for this study."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
What site did they apply to?
John Hopkins University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
2021. "Simultaneous mRNA COVID-19 and IIV4 Vaccination Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05028361.
~99 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top