Trial Outcomes & Findings for Simultaneous RZV and aIIV4 Vaccination (NCT NCT05007041)
NCT ID: NCT05007041
Last Updated: 2024-07-11
Results Overview
Modified Intention-to-Treat (mITT) Population
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
267 participants
Primary outcome timeframe
Up to 8 days post-vaccination
Results posted on
2024-07-11
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
137
|
|
Overall Study
COMPLETED
|
130
|
136
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Missing Diary Entries
|
0
|
1
|
Baseline Characteristics
Simultaneous RZV and aIIV4 Vaccination
Baseline characteristics by cohort
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=137 Participants
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
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
65-69 years
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Customized
70 or more years
|
86 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
128 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Only
|
123 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Only
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (mITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=136 Participants
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
|
|---|---|---|
|
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
|
119 Participants
|
|
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
|
17 Participants
|
PRIMARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (mITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=44 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=48 Participants
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
|
|---|---|---|
|
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
|
41 Participants
|
|
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
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (mITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=86 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=88 Participants
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
|
|---|---|---|
|
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
|
78 Participants
|
|
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
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (mITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=136 Participants
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
|
|---|---|---|
|
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
|
130 Participants
|
|
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
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (mITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=44 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=48 Participants
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
|
|---|---|---|
|
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
|
45 Participants
|
|
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
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (mITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=86 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=88 Participants
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
|
|---|---|---|
|
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
|
85 Participants
|
|
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
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=136 Participants
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
|
|---|---|---|
|
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
|
123 Participants
|
|
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
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (ITT) Population. Two subjects in the High-dose Quadrivalent Influenza arm reported local and systemic grade 3 events
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=44 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=48 Participants
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
|
|---|---|---|
|
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
|
42 Participants
|
|
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
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 8 days post-vaccinationPopulation: 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.
Modified Intention-to-Treat (ITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=86 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=88 Participants
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
|
|---|---|---|
|
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
|
7 Participants
|
|
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
|
81 Participants
|
SECONDARY outcome
Timeframe: Up 43 days post-vaccinationPopulation: ITT Population: All subjects who are randomized and vaccinated (received at least one study vaccine).
Intention-to-Treat (ITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=137 Participants
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
|
|---|---|---|
|
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
|
136 Participants
|
|
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
|
1 Participants
|
SECONDARY outcome
Timeframe: Up 43 days post-vaccinationPopulation: ITT Population: All subjects who are randomized and vaccinated (received at least one study vaccine).
Intention-to-Treat (ITT) Population
Outcome measures
| Measure |
Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 Participants
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
|
Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine
n=137 Participants
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
|
|---|---|---|
|
Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group
No
|
129 Participants
|
132 Participants
|
|
Number of Participants With at Least One Serious Adverse Event After Dose 1 of RZV (SHINGRIX®) in Each Study Group
Yes
|
1 Participants
|
5 Participants
|
Adverse Events
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
Serious events: 4 serious events
Other events: 32 other events
Deaths: 0 deaths
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Serious events: 5 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 participants at risk
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
|
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
n=137 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Cardiovascular Accident (CVA), Unspecified Mechanism
|
0.00%
0/130 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.73%
1/137 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Hepatobiliary disorders
Hepatocellular Carcinoma
|
0.77%
1/130 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.00%
0/137 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Blood and lymphatic system disorders
Acute Hyperkalemia
|
0.00%
0/130 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.73%
1/137 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/130 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.73%
1/137 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Vascular disorders
Acute pulmonary embolism and acute deep vein thrombosis
|
0.00%
0/130 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.73%
1/137 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Nervous system disorders
Left partial cranial nerve III palsy
|
0.00%
0/130 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.73%
1/137 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Musculoskeletal and connective tissue disorders
Revision of right shoulder rotator cuff surgery
|
0.77%
1/130 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.00%
0/137 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Cardiac disorders
Hospitalization for pacemaker due to arrhythmia
|
0.77%
1/130 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.00%
0/137 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease (COPD) exacerbation
|
0.77%
1/130 • Number of events 1 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
0.00%
0/137 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
Other adverse events
| Measure |
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
n=130 participants at risk
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
|
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
n=137 participants at risk
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
|
|---|---|---|
|
Infections and infestations
COVID-19 Infection
|
11.5%
15/130 • Number of events 15 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
8.0%
11/137 • Number of events 11 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
|
Infections and infestations
Upper Respiratory Infection
|
13.1%
17/130 • Number of events 17 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
7.3%
10/137 • Number of events 10 • Participants were followed through Day 43 after each dose of SHINGRIX for adverse events and adverse events of clinical interest. Participants were followed through the entire study period (up to 110 days) for serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place