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Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations

NCT06020118 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2025-06-13

Study results available
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Summary

This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.

Conditions

Interventions

BIOLOGICAL

Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)

Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.

BIOLOGICAL

Sequential Vaccination (Influenza vaccine then mRNA COVID booster)

Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.

BIOLOGICAL

Sequential Vaccination (mRNA COVID booster then Influenza vaccine)

mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.

Sponsors & Collaborators

  • Centers for Disease Control and Prevention

    collaborator FED

  • Arizona State University

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Valleywise Health

    collaborator OTHER

  • Cleveland VA Medical Center

    collaborator UNKNOWN

  • Senders Pediatrics

    collaborator UNKNOWN

  • Duke University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2024-03-07
Completion
2024-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06020118 on ClinicalTrials.gov