We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Simultaneous mRNA COVID-19 and IIV4 Vaccination Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05028361
Recruitment Status : Recruiting
First Posted : August 31, 2021
Last Update Posted : September 14, 2022
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Johns Hopkins University
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE August 30, 2021
First Posted Date  ICMJE August 31, 2021
Last Update Posted Date September 14, 2022
Actual Study Start Date  ICMJE October 4, 2021
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
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 [ Time Frame: Visit 1 and Visit 2, Up to 7 Days Post Vaccination ]
Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • 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 [ Time Frame: Visit 1, Up to 7 Days Post Vaccination ]
    Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
  • Number of participants with moderate or more severe fever, chills, myalgia, or arthralgia in the Simultaneous versus Sequential Group following the second vaccination visit [ Time Frame: Visit 2, Up to 7 Days Post Vaccination ]
    Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
  • Number of participants in the Simultaneous and Sequential vaccination groups with solicited local and systemic reactogenicity events according to severity grade after the first, second and third vaccination visit [ Time Frame: Up to 7 Days Post Vaccination ]
    Subjects will be asked to complete a memory aid to document symptoms and measure temperature daily.
  • Observed serious adverse events in both treatment groups [ Time Frame: Up to Day 121 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
Official Title  ICMJE Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza Vaccine (IIV4) in Adults and Adolescents: A Randomized Observer Blinded Study
Brief Summary This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID vaccine either simultaneously or sequentially, 14 days apart. A second dose of mRNA COVID vaccine will be administered either 3 or 4 weeks following the first dose, depending upon the mRNA COVID vaccine received for participants receiving their initial dose of mRNA COVID vaccine. For those receiving a third dose of mRNA COVID vaccine, there will not be a second dose. Solicited symptoms of reactogenicity will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Serum samples from participants will be collected for determination of COVID-19 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 immunogenicity and for potential future studies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain
  • Quality of Life
  • Injection Site Reaction
  • Adverse Drug Event
Intervention  ICMJE
  • Biological: mRNA COVID-19
    ACIP recommended vaccine
  • Biological: IIV4
    ACIP recommended vaccine
  • Other: Placebo
    Saline Control
Study Arms  ICMJE
  • Simultaneous Vaccination Group
    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 for participants receiving their primary series of mRNA COVID-19 vaccine.
    Interventions:
    • Biological: mRNA COVID-19
    • Biological: IIV4
    • Other: Placebo
  • Sequential Vaccination Group
    Subjects will receive a dose of mRNA COVID-19 vaccine (either as a study procedure or standard of care) and placebo at Visit 1, IIV4 at Visit 2, and mRNA COVID-19 vaccine at Visit 3 for participants receiving their primary series of mRNA COVID-19 vaccine.
    Interventions:
    • Biological: mRNA COVID-19
    • Biological: IIV4
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2021)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2023
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Persons aged ≥12 years if receiving primary two-dose mRNA COVID-19 vaccine series or persons aged ≥18 years if receiving a third mRNA COVID-19 vaccine dose according to FDA authorization or approval and ACIP recommendation. Note: receipt of an mRNA COVID-19 vaccine within 8 hours of enrollment is permitted
  • English or Spanish literate
  • Intention of receiving influenza vaccine and COVID-19 vaccine based on ACIP-CDC guidelines
  • Willing to provide written informed consent
  • Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and clinic visits

Exclusion Criteria:

  • Currently pregnant, planning to become pregnant within the first three months of the study per participant self-report or likely to be pregnant per screening criteria as defined in Section 5.1 at Visit 1
  • Prior receipt of IIV4 during the 2021-2022 influenza season
  • Prior receipt of non-mRNA COVID-19 vaccine
  • Prior receipt of more than 2 mRNA COVID-19 vaccines
  • Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either medical history or lab testing
  • History of severe allergic reaction after a previous dose of any influenza vaccine; or to an influenza vaccine component, including egg protein
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of an mRNA vaccine
  • Receipt of any licensed inactivated vaccine within 2 weeks prior to enrollment in this study, receipt of any licensed live vaccine within 4 weeks prior to enrollment in this study, or receipt of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) or HEPLISAV-B (Hepatitis B Vaccine (Recombinant), Adjuvanted) vaccine within 6 weeks prior to enrollment in this study or planning receipt of any vaccines following enrollment until 6 weeks after receipt of the second dose of mRNA COVID-19 vaccine
  • Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematologic malignancy*

    *Participants with a history of malignancy may be included if, after previous treatment by surgical excision, chemotherapy or radiation therapy, the participant has been observed for a period that in the investigator's estimation provides a reasonable assurance of sustained cure

  • Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable).
  • Has immunosuppression as a result of an underlying illness or medications, such as antirejection/transplant regimens or immunomodulatory agents. Stable HIV disease is permitted per the following parameters:

    a. Confirmed stable HIV disease defined as document viral load <50 copies/mL and CD4 count >200 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months

  • Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per the following parameters:

    1. If known HBV: confirmed inactive chronic HBV infection: HBsAg present for ≥6 months and HBeAg negative, anti-HBe positive; serum HBV DNA <2000 IU/mL; persistently normal ALT or AST levels; in those who had liver biopsy, findings that confirm absence of significant necroinflammation
    2. If known HCV: evidence of sustained virological response for ≥12 weeks after treatment or without evidence of HCV RNA viremia (undetectable HCV RNA)
  • Use of oral, parenteral, or high-dose inhaled glucocorticoids

    *For definition of high-dose inhaled glucocorticoids, reference Appendix B.

  • History of Guillain-Barré syndrome
  • Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product during the study period.*

    *Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period e.g. COVID-19 illness.

  • Hearing loss determined by the investigators to prevent successful communication over the phone
  • History of myocarditis or pericarditis
  • History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A).
  • Has injury or other reason why deltoid site on both arms cannot be used for vaccinations.
  • Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
  • Anyone who is a relative of any research study personnel.
  • Anyone who is an employee of any research study personnel.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Emmanual B Walter, MD, MPH 919-620-5346 chip.walter@duke.edu
Contact: Grace N Davis, MS 919-385-5786 grace.davis@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05028361
Other Study ID Numbers  ICMJE Pro00109102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Duke University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Centers for Disease Control and Prevention
  • Johns Hopkins University
  • Children's Hospital Medical Center, Cincinnati
Investigators  ICMJE
Principal Investigator: Emmanual B Walter, MD, MPH Duke University
Principal Investigator: Karen R Broder, MD Centers for Disease Control and Prevention
Principal Investigator: Kawsar Talaat, MD Johns Hopkins University
Principal Investigator: Elizabeth Schlaudecker, MD, MPH Children's Hospital Medical Center, Cincinnati
PRS Account Duke University
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP