Simultaneous RZV and aIIV4 Vaccination

Intention-to-Treat (ITT) Population: Defined as all subjects who are randomized and vaccinated.

Modified Intention-to-Treat (mITT) Population: Defined as all subjects who are randomized, vaccinated, and provide at least one day of complete data on the symptom diary.

Inclusion criteria

• Male or female age ≥ 65 years
• Intention of receiving IIV and RZV based on ACIP-CDC guidelines
• Able to speak English
• Willing to provide written informed consent
• Living in the community
• Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and clinic visits.
• If HIV positive, HIV should be clinically stable.

Exclusion criteria

• IIV or recombinant influenza vaccine (RIV) receipt during the respective 2021-2022 or 2022-2023 influenza season prior to study enrollment
• Prior receipt of recombinant zoster vaccine (SHINGRIX®)
• For non-COVID-19 Vaccines:

• Receipt of any inactivated vaccine within 2 weeks prior to enrollment in this study
• Receipt of any live vaccine within 4 weeks prior to enrollment in this study
• Planning receipt of any non-COVID-19 vaccine during the entire period
• For COVID-19 Vaccines:

• Receipt of COVID-19 vaccine within 2 weeks prior to enrollment in this study. For those who have initiated a COVID-19 vaccine series, enrollment is not allowed until 2 weeks after the final dose of a COVID-19 vaccine is completed.
• Planning receipt of a COVID-19 vaccine within 2 weeks after administration of study influenza and first dose recombinant zoster study vaccines.
• Have acute illness or exacerbation of chronic illness within 72 hours of study vaccination
• Hospitalization within the last 30 days for any reason
• History of febrile illness (> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration
• Has immunosuppression as a result of an underlying illness or treatment, or use of chemotherapy or radiation therapy within the preceding 12 months
• Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) *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
• A history of autoimmune disease, that requires immunosuppressive agents or any other chronic medical condition considered clinically significant by the investigator
• Use of chronic oral or intravenous administration (≥14 days) of immunosuppressive doses of steroids, i.e., prednisone >10 mg per day, immunosuppressants or other immune-modifying drugs within 30 days of starting this study. (Use of topical, nasal, or inhaled steroids is permitted)
• Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable)
• Contraindication to IIV receipt including history of severe allergic reaction after a previous dose of any influenza vaccine; or to a vaccine component, including egg protein
• Contraindication to RZV including history of a severe allergic reaction to any component of the RZV vaccine (including saponin or polysorbate 80) or to dose 2 of RZV
• History of Guillain-Barré syndrome
• History of Hepatitis C or active Hepatitis B
• Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination
• Dementia, any cognitive condition, or substance abuse that could interfere with study compliance
• Anyone who is already enrolled or plans to enroll in another clinical trial with an investigational product within 28 days of vaccine receipt. Co-enrollment in observational or behavioral intervention studies are allowed at any time while enrollment in a clinical trial involving an investigational product (other than vaccine) may occur after 28 days following vaccine receipt
• 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