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History of Changes for Study: NCT05028361
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
Latest version (submitted September 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 30, 2021 None (earliest Version on record)
2 October 13, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 October 25, 2021 Arms and Interventions, Eligibility, Study Description, Study Status and Study Identification
4 November 15, 2021 Study Status and Document Section
5 February 4, 2022 Study Status
6 March 21, 2022 Study Status
7 May 31, 2022 Study Status
8 June 3, 2022 Recruitment Status, Study Status and Contacts/Locations
9 June 21, 2022 Study Status
10 September 12, 2022 Recruitment Status, Study Status, Document Section and Contacts/Locations
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Study NCT05028361
Submitted Date:  August 30, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00109102
Brief Title: Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
Official Title: Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza (IIV4) in Adults and Adolescents: A Randomized Observer Blinded Study
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2021
Overall Status: Not yet recruiting
Study Start: September 15, 2021
Primary Completion: April 5, 2022 [Anticipated]
Study Completion: July 14, 2022 [Anticipated]
First Submitted: August 30, 2021
First Submitted that
Met QC Criteria:
August 30, 2021
First Posted: August 31, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
August 30, 2021
Last Update Posted: August 31, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Duke University
Responsible Party: Sponsor
Collaborators: Centers for Disease Control and Prevention
Johns Hopkins University
Children's Hospital Medical Center, Cincinnati
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to either receive quadrivalent inactivated influenza vaccine (IIV4) or saline placebo simultaneously with mRNA COVID-19 vaccine at Visit 1. Participants receiving IIV4 will receive saline placebo and participants receiving placebo will receive IIV4 14 days later at Visit 2. A second dose of mRNA COVID-19 vaccine will be administered either 3 or 4 weeks following the first dose at Visit 3, depending upon the mRNA COVID-19 vaccine received. Study staff and participants will be blinded with respect to the timing of receipt of their influenza vaccine. 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 Visit 1 and daily during the 7 days following the initial vaccination visit. Serious adverse events and adverse events of special interest will be collected at designated time points during the study. Serum samples from participants will be collected for determination of COVID-19 seropositivity at baseline. Serum samples will be taken at designated time points to determine IIV4 immunogenicity and for potential future studies.
Detailed Description:
Open or close this module Conditions
Conditions: Pain
Quality of Life
Injection Site Reaction
Adverse Drug Event
Keywords: COVID-19
Influenza
vaccine
mRNA COVID-19 vaccine
influenza vaccine
safety
quality of life
pain following vaccination
fever following vaccination
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Allocation: Randomized
Enrollment: 450 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Simultaneous Vaccination Group
Subjects will receive first 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.
Biological: Simultaneous administration of mRNA COVID-19 and IIV4
Subjects will receive an mRNA COVID-19 vaccine either as a study procedure or standard of care and IIV4 on the same day within 8 hours of administration.
No Intervention: Sequential Vaccination Group
Subjects will receive their first 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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Persons aged ≥12 years
  • 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 a COVID-19 vaccine. Note: receipt of an mRNA COVID-19 vaccine within 8 hours of enrollment is permitted.
  • 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 within 28 days of vaccine receipt.*

    *Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time, while enrollment in a clinical trial involving an investigational product will not be permitted following enrollment until 4 weeks after receipt of the second dose of mRNA COVID-19 vaccine. 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.
Open or close this module Contacts/Locations
Central Contact Person: Emmanual B Walter, MD, MPH
Telephone: 919-620-5346
Email: chip.walter@duke.edu
Central Contact Backup: Grace N Davis, MS
Telephone: 919-385-5786
Email: grace.davis@duke.edu
Study Officials: Emmanual B Walter, MD, MPH
Principal Investigator
Duke University
Karen R Broder, MD
Principal Investigator
Centers for Disease Control and Prevention
Kawsar Talaat, MD
Principal Investigator
Johns Hopkins University
Elizabeth Schlaudecker, MD, MPH
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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