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Trial record 1 of 1 for:    05028361
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Simultaneous mRNA COVID-19 and IIV4 Vaccination Study

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ClinicalTrials.gov Identifier: NCT05028361
Recruitment Status : Suspended (We will start enrollment again during the 2022-23 flu season.)
First Posted : August 31, 2021
Last Update Posted : June 7, 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

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.

Condition or disease Intervention/treatment Phase
Pain Quality of Life Injection Site Reaction Adverse Drug Event Biological: mRNA COVID-19 Biological: IIV4 Other: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : January 21, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Biological: mRNA COVID-19
ACIP recommended vaccine

Biological: IIV4
ACIP recommended vaccine

Other: Placebo
Saline Control

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.
Biological: mRNA COVID-19
ACIP recommended vaccine

Biological: IIV4
ACIP recommended vaccine

Other: Placebo
Saline Control




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Observed serious adverse events in both treatment groups [ Time Frame: Up to Day 121 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05028361


Locations
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United States, Maryland
John Hopkins University
Baltimore, Maryland, United States, 21205
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27709
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Duke University
Centers for Disease Control and Prevention
Johns Hopkins University
Children's Hospital Medical Center, Cincinnati
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] September 17, 2021

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT05028361    
Other Study ID Numbers: Pro00109102
First Posted: August 31, 2021    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
COVID-19
Influenza
vaccine
mRNA COVID-19 vaccine
influenza vaccine
safety
quality of life
pain following vaccination
fever following vaccination
Additional relevant MeSH terms:
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COVID-19
Injection Site Reaction
Drug-Related Side Effects and Adverse Reactions
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders
Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes