Adverse Drug Event, Injection Site Reaction, Pain, Quality of Life
Conditions
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
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.
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.
Interventions
BIOLOGICALFLUAD® Quadrivalent
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
BIOLOGICALFluzone® High-Dose Quadrivalent
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
BIOLOGICALSHINGRIX®
Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
Sponsors
Centers for Disease Control and Prevention
Johns Hopkins University
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Subjects, study coordinators, and investigators will be blinded to the type of influenza vaccine administered in conjunction with the Recombinant Zoster Vaccine, Adjuvanted.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female age ≥ 65 years 2. Intention of receiving IIV and RZV based on ACIP-CDC guidelines 3. Able to speak English 4. Willing to provide written informed consent 5. Living in the community 6. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls and clinic visits. 7. If HIV positive, HIV should be clinically stable.
Exclusion criteria
1. IIV or recombinant influenza vaccine (RIV) receipt during the respective 2021-2022 or 2022-2023 influenza season prior to study enrollment 2. Prior receipt of recombinant zoster vaccine (SHINGRIX®) 3. 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 4. 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. 5. Have acute illness or exacerbation of chronic illness within 72 hours of study vaccination 6. Hospitalization within the last 30 days for any reason 7. History of febrile illness (\> 100.0°F or 37.8°C) within the past 24 hours prior to IIV administration 8. Has immunosuppression as a result of an underlying illness or treatment, or use of chemotherapy or radiation therapy within the preceding 12 months 9. 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 10. A history of autoimmune disease, that requires immunosuppressive agents or any other chronic medical condition considered clinically significant by the investigator 11. 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) 12. Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating intramuscular injection (a daily aspirin may be acceptable) 13. 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 14. 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 15. History of Guillain-Barré syndrome 16. History of Hepatitis C or active Hepatitis B 17. Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study vaccination 18. Dementia, any cognitive condition, or substance abuse that could interfere with study compliance 19. 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 20. 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 21. Anyone who is a relative of any research study personnel 22. Anyone who is an employee of any research study personnel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 8 days post-vaccination | Modified Intention-to-Treat (mITT) Population |
| 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 | Up to 8 days post-vaccination | Modified Intention-to-Treat (mITT) Population |
| 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 | Up to 8 days post-vaccination | Modified Intention-to-Treat (mITT) Population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events |
| 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 | Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events |
| 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 | Modified Intention-to-Treat (mITT) Population |
| Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Up 43 days post-vaccination | Intention-to-Treat (ITT) Population |
| Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Up 43 days post-vaccination | Intention-to-Treat (ITT) Population |
| 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 | Up to 8 days post-vaccination | Modified Intention-to-Treat (ITT) Population |
| 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 | Modified Intention-to-Treat (mITT) Population |
| 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 | Modified Intention-to-Treat (mITT) Population |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine In this study arm, subjects will receive Dose 1 of RZV (SHINGRIX®) and Dose 1 of the quadrivalent adjuvanted influenza vaccine (FLUAD® Quadrivalent) simultaneously during Visit 1 and Dose 2 of RZV (SHINGRIX®) during Visit 6.
FLUAD® Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine | 130 |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine 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.
Fluzone® HD Quadrivalent: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
SHINGRIX®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine | 137 |
| Total | 267 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Missing Diary Entries | 0 | 1 |
Baseline characteristics
| Characteristic | Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Total |
|---|---|---|---|
| Age, Customized 65-69 years | 44 Participants | 48 Participants | 92 Participants |
| Age, Customized 70 or more years | 86 Participants | 89 Participants | 175 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants | 134 Participants | 262 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black Only | 7 Participants | 12 Participants | 19 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White Only | 123 Participants | 124 Participants | 247 Participants |
| Sex: Female, Male Female | 61 Participants | 69 Participants | 130 Participants |
| Sex: Female, Male Male | 69 Participants | 68 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 137 |
| other Total, other adverse events | 32 / 130 | 21 / 137 |
| serious Total, serious adverse events | 4 / 130 | 5 / 137 |
Outcome results
Primary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | No | 115 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | Yes | 15 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | No | 119 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | Yes | 17 Participants |
Comparison: The null hypothesis is simultaneous vaccination with RZV and allV4 is inferior (i.e., RZV and allV4 will have a higher proportion) to RZV and HD-IIV4 with regard to the proportion of adults with at least one severe (Grade 3) solicited local or systemic reactogenicity event on days 1-8 after RZV dosep-value: 0.003795% CI: [-8.94, 7.1]Difference in proportions
Primary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects ages 65-69 who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | No | 41 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | Yes | 3 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | No | 41 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | Yes | 7 Participants |
95% CI: [-20.22, 4.69]
Primary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects ages 70 or older who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | No | 74 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | Yes | 12 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | No | 78 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | Yes | 10 Participants |
95% CI: [-7.29, 12.47]
Secondary
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
Time frame: Up 43 days post-vaccination
Population: ITT Population: All subjects who are randomized and vaccinated (received at least one study vaccine).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 130 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 0 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 136 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Adverse Event of Clinical Interest After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 1 Participants |
95% CI: [-2.16, 0.7]Difference in proportions
Secondary
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
Time frame: Up 43 days post-vaccination
Population: ITT Population: All subjects who are randomized and vaccinated (received at least one study vaccine).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 129 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 1 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 132 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 5 Participants |
95% CI: [-6.36, 0.6]Difference in proportions
Secondary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 122 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 8 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 130 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 6 Participants |
Comparison: Number of Participants With at Least One Severe (Grade 3) Solicited Local Reactogenicity Event After SHINGRIX® Dose 1 in Each Study Groupp-value: 0.003195% CI: [-4.04, 7.77]Difference in proportions
Secondary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | No | 44 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | Yes | 0 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | No | 45 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | Yes | 3 Participants |
95% CI: [-13.1, 0.6]Difference in proportions
Secondary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects ages 70 or older who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | No | 78 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | Yes | 8 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | No | 85 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | Yes | 3 Participants |
95% CI: [-1.32, 13.11]Difference in proportions
Secondary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 123 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 7 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group | No | 123 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | Number of Participants With at Least One Severe (Grade 3) Solicited Systemic Reactogenicity After Dose 1 of RZV (SHINGRIX®) in Each Study Group | Yes | 13 Participants |
p-value: <0.000195% CI: [-10.9, 2.47]Difference in proportions
Secondary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | No | 41 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | Yes | 3 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | No | 42 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | Yes | 6 Participants |
95% CI: [-17.64, 6.28]Difference in proportions
Secondary
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
Time frame: Up to 8 days post-vaccination
Population: Modified Intention-to-Treat (mITT) Population: All subjects ages 70 or older who are randomized, vaccinated (received at least one study vaccine), and provided at least one day of complete data on the symptom diary.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | No | 82 Participants |
| Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine | 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 | Yes | 4 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | No | 81 Participants |
| Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine | 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 | Yes | 7 Participants |
95% CI: [-10.5, 3.89]Difference in proportions