COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05028361

Emmanual B Walter

Not reported

2021-08-31

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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

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: 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 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.

2

Duke University

12

100

United States

Healthy volunteers

N/A

349

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

None

Phase 4

[{"arm_notes": "Simultaneous administration+/-third dose", "treatment_id": 1967, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)+flu vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "Sequential vaccination+/-third dose", "treatment_id": 1967, "treatment_name": "Covid-19 mrna vaccine (nucleoside-modified)+flu vaccine", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]