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PainPhase 4NCT05007041

Simultaneous RZV and aIIV4 Vaccination

A Phase 4 study testing FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent and SHINGRIX® in people with Pain and Quality of Life, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Pain, Quality of Life, Injection Site Reaction
What is being tested?
FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent and SHINGRIX®
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
2 sitesUnited States
Study dates
21 Sep 2021to 8 Jun 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 27Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • Duke University

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Safety of Simultaneous Vaccination With Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aIIV4)

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.

Read the detailed description

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.

Being tested
FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent, SHINGRIX®
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
Medical subject headings
Pain, Injection Site Reaction, Drug-Related Side Effects and Adverse Reactions, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLUAD® QuadrivalentBiological

    Also called Influenza Vaccine, Adjuvanted (Quadrivalent), aIIV4

    Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

  • Fluzone® High-Dose QuadrivalentBiological

    Also called High-Dose Quadrivalent Influenza Vaccine, HD-IIV4

    Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

  • SHINGRIX®Biological

    Also called Zoster Vaccine Recombinant, Adjuvanted (RZV)

    Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine

Study groups in NCT05007041
Study groupRoleWhat they receive
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine (FLUAD®)Active comparatorIn 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.
Receives: Biological: FLUAD® Quadrivalent; Biological: SHINGRIX®
Zoster Vaccine Recombinant (RZV) and High-Dose Quadrivalent Influenza Vaccine (Fluzone®)Active comparatorIn 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.
Receives: Biological: Fluzone® High-Dose Quadrivalent; Biological: SHINGRIX®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 8 days post-vaccination

  2. 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

    Measured: Up to 8 days post-vaccination

  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 - Ages 70 and Older

    Modified Intention-to-Treat (mITT) Population

    Measured: Up to 8 days post-vaccination

Secondary outcomes (8)

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

    Modified Intention-to-Treat (mITT) Population

    Measured: Up to 8 days post-vaccination

  2. 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

    Modified Intention-to-Treat (mITT) Population

    Measured: Up to 8 days post-vaccination

  3. 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

    Modified Intention-to-Treat (mITT) Population

    Measured: Up to 8 days post-vaccination

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

    Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events

    Measured: Up to 8 days post-vaccination

  5. 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

    Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events

    Measured: Up to 8 days post-vaccination

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

    Modified Intention-to-Treat (ITT) Population

    Measured: Up to 8 days post-vaccination

  7. Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group

    Intention-to-Treat (ITT) Population

    Measured: Up 43 days post-vaccination

  8. Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group

    Intention-to-Treat (ITT) Population

    Measured: Up 43 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start21 Sep 2021
  3. Primary completion4 Mar 2023
  4. Study completion8 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007041
Sponsor's protocol ID
Pro00108456
Status last verified
Jun 2024
First submitted
9 Aug 2021
Last updated
11 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39446325

  • 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.

    PubMed 37781954

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent and SHINGRIX® in people with Pain and Quality of Life, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to 8 days post-vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007041, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.

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