Simultaneous RZV and aIIV4 Vaccination

NCT05007041 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00108456
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 2

Brief Summary

The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vaccine in persons age ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, and 180 older adults at Johns Hopkins University Medical Center. Eligible subjects will be randomized to receive either simultaneous RZV/FLUAD® or RZV/Fluzone® High-Dose vaccines. All subjects will be assessed for 7 days post-injection and safety and tolerability compared between the two groups. Serious adverse events and adverse events of clinical interest will be assessed 42 days post-vaccination and compared between the two groups. Health-related quality of life will be assessed pre-vaccination Day 1 through Day 8. Serious Adverse Events and Adverse Events of Clinical Interest were also assessed throughout the study period.

Conditions

Pain; Quality of Life; Injection Site Reaction; Adverse Drug Event

Keywords

influenza vaccine; fever following vaccination; pain following vaccination; quality of life; Zoster Vaccine Recombinant, Adjuvanted (RSV) (SHINGRIX®); Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®); Fluzone(®) High-Dose Quadrivalent

Outcome Measures

Primary Outcomes (3)

• Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group

  Modified Intention-to-Treat (mITT) Population

  Up to 8 days post-vaccination

• Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 65-69

  Modified Intention-to-Treat (mITT) Population

  Up to 8 days post-vaccination

• Number of Participants With at Least One Severe (Grade 3) Solicited Local or Systemic Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older

  Modified Intention-to-Treat (mITT) Population

  Up to 8 days post-vaccination

Secondary Outcomes (8)

• Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group

  Up to 8 days post-vaccination

• Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®)in Each Study Group - Ages 65-69

  Up to 8 days post-vaccination

• Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 70 and Older

  Up to 8 days post-vaccination

• Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group

  Up to 8 days post-vaccination

• Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group - Ages 65-69

  Up to 8 days post-vaccination

Study Arms (2)

Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine (FLUAD®)

ACTIVE COMPARATOR

In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.

Biological: FLUAD® Quadrivalent; Biological: SHINGRIX®

Zoster Vaccine Recombinant (RZV) and High-Dose Quadrivalent Influenza Vaccine (Fluzone®)

ACTIVE COMPARATOR

In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the (Fluzone® HD Quadrivalent) influenza vaccine simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.

Biological: Fluzone® High-Dose Quadrivalent; Biological: SHINGRIX®

Interventions

FLUAD® Quadrivalent BIOLOGICAL

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Also known as: Influenza Vaccine, Adjuvanted (Quadrivalent), aIIV4

Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine (FLUAD®)

Fluzone® High-Dose Quadrivalent BIOLOGICAL

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Also known as: High-Dose Quadrivalent Influenza Vaccine, HD-IIV4

Zoster Vaccine Recombinant (RZV) and High-Dose Quadrivalent Influenza Vaccine (Fluzone®)

SHINGRIX® BIOLOGICAL

Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Also known as: Zoster Vaccine Recombinant, Adjuvanted (RZV)

Zoster Vaccine Recombinant (RZV) and High-Dose Quadrivalent Influenza Vaccine (Fluzone®); Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine (FLUAD®)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Centers for Disease Control and Prevention: collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• Schmader KE, Walter EB, Talaat KR, Rountree W, Poniewierski M, Randolph E, Leng SX, Wunderlich B, McNeil MM, Museru O, Broder KR. Safety of Simultaneous Vaccination With Adjuvanted Zoster Vaccine and Adjuvanted Influenza Vaccine: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2440817. doi: 10.1001/jamanetworkopen.2024.40817.

  PMID: 39446325 DERIVED

• de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

  PMID: 37781954 DERIVED

MeSH Terms

Conditions

Pain; Injection Site Reaction; Drug-Related Side Effects and Adverse Reactions; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Chemically-Induced Disorders; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Dr. Kenneth Schmader
• Organization: Duke University

kenneth.schmader@duke.edu

919-660-7572

Study Officials

• Kenneth Schmader, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, study coordinators, and investigators will be blinded to the type of influenza vaccine administered in conjunction with the Recombinant Zoster Vaccine, Adjuvanted.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 16, 2021
• Study Start: September 21, 2021
• Primary Completion: March 4, 2023
• Study Completion: June 8, 2023
• Last Updated: July 11, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)