Trial Outcomes & Findings for FLUAD® vs. Fluzone® High-Dose Study (NCT NCT03183908)
NCT ID: NCT03183908
Last Updated: 2021-03-30
Results Overview
Comparison of the proportion of subjects reporting moderate/severe injection site pain within the first week post-vaccination in both treatment groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
757 participants
Primary outcome timeframe
Days 1 through 8 post-vaccination
Results posted on
2021-03-30
Participant Flow
Participant milestones
| Measure |
Influenza Vaccine, Adjuvanted (FLUAD®)
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-Dose Influenza Vaccine (Fluzone HD)
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
378
|
379
|
|
Overall Study
COMPLETED
|
378
|
377
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Influenza Vaccine, Adjuvanted (FLUAD®)
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-Dose Influenza Vaccine (Fluzone HD)
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Overall Study
Missing Symptom Diary Data
|
0
|
2
|
Baseline Characteristics
FLUAD® vs. Fluzone® High-Dose Study
Baseline characteristics by cohort
| Measure |
Adjuvanted Influenza Vaccine (FLUAD)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone HD)
n=379 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
Total
n=757 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age Group · 65-79 Years
|
298 Participants
n=99 Participants
|
296 Participants
n=107 Participants
|
594 Participants
n=206 Participants
|
|
Age, Customized
Age Group · 80 or More
|
80 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=99 Participants
|
207 Participants
n=107 Participants
|
420 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
337 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
346 Participants
n=99 Participants
|
351 Participants
n=107 Participants
|
697 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black only
|
70 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
22 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White Only
|
286 Participants
n=99 Participants
|
303 Participants
n=107 Participants
|
589 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
378 participants
n=99 Participants
|
379 participants
n=107 Participants
|
757 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Days 1 through 8 post-vaccinationPopulation: Full Analysis Population 1
Comparison of the proportion of subjects reporting moderate/severe injection site pain within the first week post-vaccination in both treatment groups.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=377 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
None
|
297 Participants
|
282 Participants
|
|
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
Mild
|
69 Participants
|
73 Participants
|
|
Number of Participants With Injection-Site Pain in Arm That Was Vaccinated, Population 1
Mod/Severe
|
12 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 42 days post-vaccination and compared between the two groups.Population: Full Analysis Population 2
The frequency and descriptions of adverse events of clinical interest observed in the two treatment groups.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=379 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With Adverse Events of Clinical Interest, Population 2
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 42 days post-vaccination and compared between the two groups.Population: Full Analysis Population 2
The frequency and descriptions of serious adverse events observed in the two treatment groups. No analytical analysis was completed.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=379 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Fall
|
2 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Metastatic squamous cell
|
0 SAE Events
|
1 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Post-operative ileus
|
0 SAE Events
|
1 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Respiratory Failure
|
1 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Stress induced cardiomyopathy
|
1 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
TIA
|
1 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Chest Pain
|
0 SAE Events
|
1 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Asthma exacerbation
|
1 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Near syncope due to orthostasis
|
1 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Pulmonary emboli
|
1 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
Small bowel obstruction
|
1 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
SAEs related to study product
|
0 SAE Events
|
0 SAE Events
|
|
Observed Serious Adverse Events in Both Treatment Groups, Population 2
SAEs not related to study product
|
9 SAE Events
|
3 SAE Events
|
PRIMARY outcome
Timeframe: 29 days post-vaccinationPopulation: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
H3N2 hemagglutination inhibition assay (HAI) seroconversion: The proportion of subjects achieving H3N2 seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer is \> 1:10) in the respective season's vaccine
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=342 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=338 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With H3N2 HAI Seroconversion
|
112 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 8 post-vaccinationPopulation: Full Analysis Population 1
Comparison of local reactions within the first week post-vaccination in both treatment groups.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=377 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Redness · None
|
348 Participants
|
341 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Redness · Mild
|
24 Participants
|
23 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Redness · Mod/Severe
|
6 Participants
|
13 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Shoulder Pain · None
|
317 Participants
|
326 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Shoulder Pain · Mild
|
44 Participants
|
36 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Shoulder Pain · Mod/Severe
|
17 Participants
|
15 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Swelling · None
|
335 Participants
|
23 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Swelling · Mild
|
34 Participants
|
26 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Swelling · Mod/Severe
|
9 Participants
|
328 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Tenderness · None
|
201 Participants
|
196 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Tenderness · Mild
|
150 Participants
|
160 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Full Study, Population 1
Tenderness · Mod/Severe
|
27 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 8 post-vaccinationPopulation: Participants 65-79 years of age in Full Analysis Population 1
Comparison of local reactions within the first week post-vaccination in both treatment groups by age group.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=298 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=294 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Redness · None
|
274 Participants
|
267 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Redness · Mild
|
21 Participants
|
17 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Redness · Mod/Severe
|
3 Participants
|
10 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Shoulder Pain · None
|
246 Participants
|
249 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Shoulder Pain · Mild
|
36 Participants
|
33 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Shoulder Pain · Mod/Severe
|
16 Participants
|
12 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Swelling · None
|
264 Participants
|
253 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Swelling · Mild
|
28 Participants
|
22 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Swelling · Mod/Severe
|
6 Participants
|
19 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Tenderness · None
|
157 Participants
|
138 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Tenderness · Mild
|
117 Participants
|
137 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Tenderness · Mod/Severe
|
24 Participants
|
19 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Injection Site Pain · None
|
232 Participants
|
210 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Injection Site Pain · Mild
|
56 Participants
|
65 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 65 - 79, Population 1
Injection Site Pain · Mod/Severe
|
10 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 8 post-vaccinationPopulation: Participants 80+ years of age in Full Analysis Population 1
Comparison of local reactions within the first week post-vaccination in both treatment groups by age group.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=80 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=83 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Redness · None
|
74 Participants
|
74 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Redness · Mild
|
3 Participants
|
6 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Redness · Mod/Severe
|
3 Participants
|
3 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Shoulder Pain · None
|
71 Participants
|
77 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Shoulder Pain · Mild
|
8 Participants
|
3 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Shoulder Pain · Mod/Severe
|
1 Participants
|
3 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Swelling · None
|
71 Participants
|
75 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Swelling · Mild
|
6 Participants
|
4 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Swelling · Mod/Severe
|
3 Participants
|
4 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Tenderness · None
|
44 Participants
|
58 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Tenderness · Mild
|
33 Participants
|
23 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Tenderness · Mod/Severe
|
3 Participants
|
2 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Injection Site Pain · None
|
65 Participants
|
72 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Injection Site Pain · Mild
|
13 Participants
|
8 Participants
|
|
Number of Participants With Local Reactions in Arm That Was Vaccinated - Ages 80 +, Population 1
Injection Site Pain · Mod/Severe
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 8 post-vaccinationPopulation: Full Analysis Population 1: Four missing patient-reported outcome measures for "Fever" outcome.
Comparison of systemic reactions within the first week post-vaccination in both treatment groups.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=377 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Arthralgia · None
|
340 Participants
|
346 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Arthralgia · Mild
|
20 Participants
|
20 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Arthralgia · Mod/Severe
|
18 Participants
|
11 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Chills/Shivering · None
|
362 Participants
|
363 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Chills/Shivering · Mild
|
13 Participants
|
9 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Chills/Shivering · Mod/Severe
|
3 Participants
|
5 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Diarrhea · None
|
358 Participants
|
359 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Diarrhea · Mild
|
15 Participants
|
9 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Diarrhea · Mod/Severe
|
5 Participants
|
9 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Fatigue · None
|
319 Participants
|
337 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Fatigue · Mild
|
32 Participants
|
25 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Fatigue · Mod/Severe
|
27 Participants
|
15 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Fever · None
|
366 Participants
|
358 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Fever · Mild
|
11 Participants
|
12 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Fever · Mod/Severe
|
1 Participants
|
3 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Headache · None
|
335 Participants
|
338 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Headache · Mild
|
36 Participants
|
31 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Headache · Mod/Severe
|
7 Participants
|
8 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Malaise · None
|
332 Participants
|
344 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Malaise · Mild
|
28 Participants
|
22 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Malaise · Mod/Severe
|
18 Participants
|
11 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Myalgia · None
|
334 Participants
|
338 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Myalgia · Mild
|
25 Participants
|
22 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Myalgia · Mod/Severe
|
19 Participants
|
17 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Nausea · None
|
357 Participants
|
362 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Nausea · Mild
|
19 Participants
|
10 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Nausea · Mod/Severe
|
2 Participants
|
5 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Vomiting · None
|
374 Participants
|
374 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Vomiting · Mild
|
2 Participants
|
1 Participants
|
|
Number of Participants With Systemic Reactions - Full Study Population, Population 1
Vomiting · Mod/Severe
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 8 post-vaccinationPopulation: Participants 65-79 years of age in Full Analysis Population 1: Three missing "Fever" outcome values for the Fluzone HD group.
Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=298 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=294 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Arthralgia · None
|
266 Participants
|
266 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Arthralgia · Mild
|
16 Participants
|
19 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Arthralgia · Mod/Severe
|
16 Participants
|
9 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Chills/Shivering · None
|
283 Participants
|
282 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Chills/Shivering · Mild
|
12 Participants
|
7 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Chills/Shivering · Mod/Severe
|
3 Participants
|
5 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Diarrhea · None
|
280 Participants
|
280 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Diarrhea · Mild
|
13 Participants
|
7 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Diarrhea · Mod/Severe
|
5 Participants
|
7 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Fatigue · None
|
248 Participants
|
258 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Fatigue · Mild
|
27 Participants
|
22 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Fatigue · Mod/Severe
|
23 Participants
|
14 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Fever · None
|
288 Participants
|
278 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Fever · Mild
|
10 Participants
|
10 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Fever · Mod/Severe
|
0 Participants
|
3 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Headache · None
|
259 Participants
|
257 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Headache · Mild
|
32 Participants
|
29 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Headache · Mod/Severe
|
7 Participants
|
8 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Malaise · None
|
260 Participants
|
264 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Malaise · Mild
|
24 Participants
|
19 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Malaise · Mod/Severe
|
14 Participants
|
11 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Myalgia · None
|
262 Participants
|
261 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Myalgia · Mild
|
20 Participants
|
19 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Myalgia · Mod/Severe
|
16 Participants
|
14 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Nausea · None
|
280 Participants
|
280 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Nausea · Mild
|
16 Participants
|
9 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Nausea · Mod/Severe
|
2 Participants
|
5 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Vomiting · None
|
294 Participants
|
291 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Vomiting · Mild
|
2 Participants
|
1 Participants
|
|
Number of Participants With System Reactions - Ages 65 - 79, Population 1
Vomiting · Mod/Severe
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1 through 8 post-vaccinationPopulation: Participants 80+ years of age in Full Analysis Population 1: One missing "Fever" outcome value in the Fluzone HD group. No statistical analysis completed on following Outcomes: Chills/Shivering, Headache, Nausea, Vomiting because none reported in this age group.
Comparison of systemic reactions within the first week post-vaccination in both treatment groups by age group.
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=80 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=83 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Nausea · None
|
77 Participants
|
82 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Arthralgia · None
|
74 Participants
|
80 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Arthralgia · Mild
|
4 Participants
|
1 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Arthralgia · Mod/Severe
|
2 Participants
|
2 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Chills/Shivering · None
|
79 Participants
|
81 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Chills/Shivering · Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Chills/Shivering · Mod/Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Diarrhea · None
|
78 Participants
|
79 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Diarrhea · Mild
|
2 Participants
|
2 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Diarrhea · Mod/Severe
|
0 Participants
|
2 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Fatigue · None
|
71 Participants
|
79 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Fatigue · Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Fatigue · Mod/Severe
|
4 Participants
|
1 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Fever · None
|
78 Participants
|
80 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Fever · Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Fever · Mod/Severe
|
1 Participants
|
0 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Headache · None
|
76 Participants
|
81 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Headache · Mild
|
4 Participants
|
2 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Headache · Mod/Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Malaise · None
|
72 Participants
|
80 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Malaise · Mild
|
4 Participants
|
3 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Malaise · Mod/Severe
|
4 Participants
|
0 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Myalgia · None
|
72 Participants
|
77 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Myalgia · Mild
|
5 Participants
|
3 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Myalgia · Mod/Severe
|
3 Participants
|
3 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Nausea · Mild
|
3 Participants
|
1 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Nausea · Mod/Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Vomiting · None
|
80 Participants
|
83 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Vomiting · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants With System Reactions - Ages 80 +, Population 1
Vomiting · Mod/Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: LLFDI data collected for only one year.
Change in scores on the Late Life Function \& Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=138 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=141 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - Late Life Function & Disability Instrument - Full Population
Activity Limitation
|
-1.43 score on a scale
Interval -2.2 to -0.66
|
-2.25 score on a scale
Interval -2.99 to -1.51
|
|
Quality of Life - Late Life Function & Disability Instrument - Full Population
Daily Activities
|
-1.26 score on a scale
Interval -2.04 to -0.48
|
-2.06 score on a scale
Interval -2.77 to -1.35
|
|
Quality of Life - Late Life Function & Disability Instrument - Full Population
Basic Mobility
|
-1.37 score on a scale
Interval -2.06 to -0.68
|
-2.43 score on a scale
Interval -3.14 to -1.72
|
|
Quality of Life - Late Life Function & Disability Instrument - Full Population
Participation Restriction
|
-0.86 score on a scale
Interval -1.57 to -0.15
|
-1.58 score on a scale
Interval -2.31 to -0.85
|
|
Quality of Life - Late Life Function & Disability Instrument - Full Population
Social Roles
|
-0.77 score on a scale
Interval -1.55 to 0.01
|
-1.80 score on a scale
Interval -2.58 to -1.02
|
|
Quality of Life - Late Life Function & Disability Instrument - Full Population
Instrumental Roles
|
-1.08 score on a scale
Interval -1.82 to -0.34
|
-1.66 score on a scale
Interval -2.41 to -0.91
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: Participants 65-79 years of age. LLFDI data collected for only one year.
Change in scores on the Late Life Function \& Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=119 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=120 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Activity Limitation
|
-1.35 score on a scale
Interval -2.2 to -0.5
|
-2.12 score on a scale
Interval -2.91 to -1.33
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Daily Activities
|
-1.16 score on a scale
Interval -2.02 to -0.3
|
-1.88 score on a scale
Interval -2.6 to -1.15
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Basic Mobility
|
-1.33 score on a scale
Interval -2.09 to -0.056
|
-2.29 score on a scale
Interval -3.03 to -1.55
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Participation Restriction
|
-0.81 score on a scale
Interval -1.52 to -0.1
|
-1.69 score on a scale
Interval -2.44 to -0.93
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Social Roles
|
-0.66 score on a scale
Interval -1.46 to 0.14
|
-1.98 score on a scale
Interval -2.82 to -1.14
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 65 - 79
Instrumental Roles
|
-1.00 score on a scale
Interval -1.74 to -0.27
|
-1.70 score on a scale
Interval -2.47 to -0.93
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: Participants 80+ years of age. LLFDI data collected for only one year.
Change in scores on the Late Life Function \& Disability Instrument pre-vaccination to post-vaccination (Day 1 - Day 3) compared between the vaccination groups (Year 1 only). Response choices are ranked 1-5, High Scores indicate better outcomes. The Function/Activity Scale measured the amount of difficulty in completing a range of activities, or the amount of help required in doing an activity due to physical or mental heath. : None (5); A little (4) ; Some (3), Quite a lot (2), and Cannot Do (1). The Disability/Participation Scale measured participation levels in social, family, and community activities due to physical or mental health. Each question has two parts. For the first part of the question, response choices include: Very often (5), Often (4), Once in a while (3), Almost never (2), Never (1). For the second part of the question, response choices include: Not at all (5), A little (4), Somewhat (3), A lot (2), and Completely (1).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=19 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=21 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Activity Limitation
|
-1.94 score on a scale
Interval -3.81 to -0.08
|
-2.99 score on a scale
Interval -5.25 to -0.74
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Daily Activities
|
-1.86 score on a scale
Interval -3.74 to 0.03
|
-3.13 score on a scale
Interval -5.65 to -0.61
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Basic Mobility
|
-1.62 score on a scale
Interval -3.22 to -0.02
|
-3.23 score on a scale
Interval -5.58 to -0.88
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Participation Restriction
|
-1.17 score on a scale
Interval -4.0 to 1.67
|
-0.97 score on a scale
Interval -3.54 to 1.6
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Social Roles
|
-1.45 score on a scale
Interval -4.31 to 1.41
|
-0.72 score on a scale
Interval -2.98 to 1.53
|
|
Quality of Life - Late Life Function & Disability Instrument - Ages 80 +
Instrumental Roles
|
-1.54 score on a scale
Interval -4.49 to 1.42
|
-1.44 score on a scale
Interval -4.1 to 1.22
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: EQ-5D-5L data collected for only one year.
Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only). Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=377 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - EQ-5D-5L -Full Population
|
-0.054 Change in score
Interval -0.064 to -0.044
|
-0.053 Change in score
Interval -0.063 to -0.044
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: Participants 65-79 years of age. EQ-5D-5L data collected for only one year.
Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=298 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=296 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - EQ-5D-5L - Ages 65 - 79
|
-0.054 Change in score
Interval -0.065 to -0.042
|
-0.051 Change in score
Interval -0.062 to -0.04
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: Participants 80+ years of age. EQ-5D-5L data collected for only one year.
Change in scores on the EuroQOL 5 dimensions-5 level (EQ-5D-5L) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only) Responses on the EQ-5D-5L measure is converted to a Utility Index that ranges from -0.109 (worst health) to 1.000 (best health).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=80 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=83 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - EQ-5D-5L - Ages 80 +
|
-0.055 Change in score
Interval -0.074 to -0.035
|
-0.062 Change in score
Interval -0.083 to -0.042
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: EQ VAS data collected for only one year.
Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=377 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - EQ VAS -Full Population
|
-2.222 Change in score
Interval -3.379 to -1.065
|
-2.496 Change in score
Interval -3.452 to -1.539
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: Participants 65-79 years of age.
Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=298 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=296 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - EQ VAS - Ages 65 - 79
|
-2.474 Change in score
Interval -3.876 to -1.071
|
-2.791 Change in score
Interval -3.923 to -1.658
|
SECONDARY outcome
Timeframe: Pre-vaccination (Day 1), 2 days post-vaccination (Day 3)Population: Participants 80+ years of age.
Change in scores on the EuroQOL visual analogue scale (EQ VAS) pre-vaccination and post-vaccination compared between the vaccination groups and age group (Year 1 only). The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' (100) and 'the worst health you can imagine' (0).
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=80 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=83 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Quality of Life - EQ VAS - Ages 80 +
|
-1.295 Change in score
Interval -2.966 to 0.377
|
-1.463 Change in score
Interval -3.163 to 0.237
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
The proportion of subjects achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=342 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=338 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Seroconversion - 65 and Older
A/H1N1
|
28.1 percentage of participants
Interval 23.4 to 33.2
|
26.6 percentage of participants
Interval 22.0 to 31.7
|
|
Seroconversion - 65 and Older
Influenza B
|
18.7 percentage of participants
Interval 14.7 to 23.3
|
23.4 percentage of participants
Interval 19.0 to 28.3
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
Proportion of subjects with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=342 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=338 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Seroprotection - 65 and Older
A/H1N1 - Baseline
|
69.6 percentage of participants
Interval 64.4 to 74.4
|
66.9 percentage of participants
Interval 61.6 to 71.8
|
|
Seroprotection - 65 and Older
A/H1N1 - Post-vaccination
|
83.3 percentage of participants
Interval 79.0 to 87.1
|
83.4 percentage of participants
Interval 79.0 to 87.2
|
|
Seroprotection - 65 and Older
A/H3N2 - Baseline
|
66.7 percentage of participants
Interval 61.4 to 71.6
|
65.7 percentage of participants
Interval 60.4 to 70.7
|
|
Seroprotection - 65 and Older
A/H3N2 - Post-vaccination
|
89.8 percentage of participants
Interval 86.1 to 92.7
|
88.5 percentage of participants
Interval 84.6 to 91.6
|
|
Seroprotection - 65 and Older
Influenza B - Baseline
|
24.6 percentage of participants
Interval 20.1 to 29.5
|
26.9 percentage of participants
Interval 22.3 to 32.0
|
|
Seroprotection - 65 and Older
Influenza B - Post-vaccination
|
44.2 percentage of participants
Interval 38.8 to 49.6
|
48.8 percentage of participants
Interval 43.4 to 54.3
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=342 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=338 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Geometric Mean HAI Titer - 65 and Older
A/H1N1 - Baseline
|
51.8 GMT
Interval 44.5 to 60.3
|
50.8 GMT
Interval 43.4 to 59.4
|
|
Geometric Mean HAI Titer - 65 and Older
A/H1N1 - Post-vaccination
|
100.0 GMT
Interval 86.6 to 115.6
|
98.0 GMT
Interval 84.6 to 113.6
|
|
Geometric Mean HAI Titer - 65 and Older
A/H3N2 - Baseline
|
63.4 GMT
Interval 52.8 to 76.1
|
58.5 GMT
Interval 48.4 to 70.7
|
|
Geometric Mean HAI Titer - 65 and Older
A/H3N2 - Post-vaccination
|
141.7 GMT
Interval 123.2 to 162.9
|
177.3 GMT
Interval 152.7 to 205.9
|
|
Geometric Mean HAI Titer - 65 and Older
Influenza B - Baseline
|
13.4 GMT
Interval 11.9 to 15.0
|
14.7 GMT
Interval 12.9 to 16.7
|
|
Geometric Mean HAI Titer - 65 and Older
Influenza B - Post-vaccination
|
21.6 GMT
Interval 18.5 to 25.2
|
27.5 GMT
Interval 23.5 to 32.3
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
The proportion of subjects aged 65-79 achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=269 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=261 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Seroconversion - Ages 65-79
A/H1N1
|
29.7 percentage of participants
Interval 24.3 to 35.6
|
27.2 percentage of participants
Interval 21.9 to 33.0
|
|
Seroconversion - Ages 65-79
A/H3N2
|
34.2 percentage of participants
Interval 28.5 to 40.2
|
39.5 percentage of participants
Interval 33.5 to 45.7
|
|
Seroconversion - Ages 65-79
Influenza B
|
19.0 percentage of participants
Interval 14.5 to 24.2
|
26.1 percentage of participants
Interval 20.8 to 31.8
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
The proportion of subjects ages 80 and older achieving seroconversion at day 29 (an HAI titer \> 1:40 at day 29 if the baseline titer is \< 1:10 or a four-fold rise in HAI titer if the baseline titer
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=73 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=77 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Seroconversion - Ages 80 and Older
A/H1N1
|
21.9 percentage of participants
Interval 13.1 to 33.1
|
24.7 percentage of participants
Interval 15.6 to 35.8
|
|
Seroconversion - Ages 80 and Older
A/H3N2
|
27.4 percentage of participants
Interval 17.6 to 39.1
|
35.1 percentage of participants
Interval 24.5 to 46.7
|
|
Seroconversion - Ages 80 and Older
Influenza B
|
17.8 percentage of participants
Interval 9.8 to 28.5
|
14.3 percentage of participants
Interval 7.4 to 24.1
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
Proportion of subjects ages 65-79 with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=269 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=261 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Seroprotection - Ages 65-79
A/H1N1 - Baseline
|
69.9 percentage of participants
Interval 64.0 to 75.3
|
65.5 percentage of participants
Interval 59.4 to 71.2
|
|
Seroprotection - Ages 65-79
A/H1N1 - Post-vaccination
|
83.6 percentage of participants
Interval 78.7 to 87.8
|
82.8 percentage of participants
Interval 77.6 to 87.1
|
|
Seroprotection - Ages 65-79
A/H3N2 - Baseline
|
67.3 percentage of participants
Interval 61.3 to 72.8
|
65.5 percentage of participants
Interval 59.4 to 71.2
|
|
Seroprotection - Ages 65-79
A/H3N2 - Post-vaccination
|
91.4 percentage of participants
Interval 87.4 to 94.4
|
88.1 percentage of participants
Interval 83.6 to 91.7
|
|
Seroprotection - Ages 65-79
Influenza B - Baseline
|
22.3 percentage of participants
Interval 17.5 to 27.8
|
19.9 percentage of participants
Interval 15.3 to 25.3
|
|
Seroprotection - Ages 65-79
Influenza B - Post-vaccination
|
42.4 percentage of participants
Interval 36.4 to 48.5
|
45.2 percentage of participants
Interval 39.1 to 51.5
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
Proportion of subjects ages 80 and older with a seroprotective HAI titer (≥ 1:40) pre- and post-immunization at day 29 for each IIV antigen in the respective season's vaccine
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=73 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=77 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Seroprotection - Ages 80 and Older
A/H1N1 - Baseline
|
68.5 percentage of participants
Interval 56.6 to 78.7
|
71.4 percentage of participants
Interval 60.0 to 81.0
|
|
Seroprotection - Ages 80 and Older
A/H1N1 - Post-vaccination
|
82.2 percentage of participants
Interval 71.5 to 89.9
|
85.7 percentage of participants
Interval 75.9 to 92.4
|
|
Seroprotection - Ages 80 and Older
A/H3N2 - Baseline
|
64.4 percentage of participants
Interval 52.3 to 75.1
|
66.2 percentage of participants
Interval 54.6 to 76.5
|
|
Seroprotection - Ages 80 and Older
A/H3N2 - Post-vaccination
|
83.6 percentage of participants
Interval 73.0 to 91.0
|
89.6 percentage of participants
Interval 80.6 to 95.2
|
|
Seroprotection - Ages 80 and Older
Influenza B - Baseline
|
32.9 percentage of participants
Interval 22.3 to 44.8
|
50.6 percentage of participants
Interval 39.0 to 62.2
|
|
Seroprotection - Ages 80 and Older
Influenza B - Post-vaccination
|
50.7 percentage of participants
Interval 38.7 to 62.5
|
61.0 percentage of participants
Interval 49.2 to 71.8
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 65-79
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=269 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=261 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Geometric Mean HAI Titer - Ages 65-79
A/H1N1 - Baseline
|
52.5 GMT
Interval 44.3 to 62.2
|
49.5 GMT
Interval 41.4 to 59.0
|
|
Geometric Mean HAI Titer - Ages 65-79
A/H1N1 - Post-vaccination
|
108.8 GMT
Interval 92.1 to 128.5
|
100.9 GMT
Interval 84.9 to 119.9
|
|
Geometric Mean HAI Titer - Ages 65-79
A/H3N2 - Baseline
|
63.3 GMT
Interval 51.7 to 77.5
|
56.4 GMT
Interval 45.5 to 69.8
|
|
Geometric Mean HAI Titer - Ages 65-79
A/H3N2 - Post-vaccination
|
145.3 GMT
Interval 124.3 to 169.7
|
184.4 GMT
Interval 155.2 to 219.1
|
|
Geometric Mean HAI Titer - Ages 65-79
Influenza B - Baseline
|
12.2 GMT
Interval 10.8 to 13.8
|
11.8 GMT
Interval 10.3 to 13.4
|
|
Geometric Mean HAI Titer - Ages 65-79
Influenza B - Post-vaccination
|
20.3 GMT
Interval 17.2 to 24.1
|
23.8 GMT
Interval 20.0 to 28.4
|
SECONDARY outcome
Timeframe: Day 29 (28 days post-vaccination)Population: Immunogenicity Population - subjects receiving the study intervention. Participants analyzed include those that provided baseline and Visit 4 blood draws of acceptable volume and quality within the protocol-defined time frame with no protocol violations affecting immunogenicity.
The geometric mean HAI titer (GMT) for each IIV antigen in the respective season's vaccine for ages 80 and older
Outcome measures
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=73 Participants
In the study arm, subjects will receive a single dose of FLUAD adjuvanted influenza vaccine during Visit 1.
FLUAD: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=77 Participants
In the study arm, subjects will receive a single dose of Fluzone High-Dose influenza vaccine during Visit 1.
Fluzone High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Geometric Mean HAI Titer - Ages 80 and Older
A/H1N1 - Baseline
|
49.3 GMT
Interval 35.1 to 69.3
|
55.6 GMT
Interval 39.2 to 78.8
|
|
Geometric Mean HAI Titer - Ages 80 and Older
A/H1N1 - Post-vaccination
|
73.4 GMT
Interval 55.2 to 97.7
|
88.7 GMT
Interval 66.7 to 118.0
|
|
Geometric Mean HAI Titer - Ages 80 and Older
A/H3N2 - Baseline
|
63.7 GMT
Interval 41.4 to 98.0
|
66.5 GMT
Interval 43.9 to 101.0
|
|
Geometric Mean HAI Titer - Ages 80 and Older
A/H3N2 - Post-vaccination
|
129.2 GMT
Interval 93.4 to 178.8
|
155.0 GMT
Interval 114.2 to 210.5
|
|
Geometric Mean HAI Titer - Ages 80 and Older
Influenza B - Baseline
|
18.7 GMT
Interval 14.6 to 24.0
|
31.2 GMT
Interval 23.2 to 42.1
|
|
Geometric Mean HAI Titer - Ages 80 and Older
Influenza B - Post-vaccination
|
27.0 GMT
Interval 19.0 to 38.2
|
45.0 GMT
Interval 31.8 to 63.5
|
Adverse Events
Adjuvanted Influenza Vaccine (FLUAD®)
Serious events: 10 serious events
Other events: 15 other events
Deaths: 1 deaths
High-dose Influenza Vaccine (Fluzone® HD)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 participants at risk
In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1.
FLUAD®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=379 participants at risk
In the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1.
Fluzone® High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.26%
1/379 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
General disorders
Fall
|
0.53%
2/378 • Number of events 2 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.00%
0/379 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Blood and lymphatic system disorders
Metastatic squamous cell
|
0.00%
0/378 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.26%
1/379 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Gastrointestinal disorders
Post-operative ileus
|
0.00%
0/378 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.26%
1/379 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.00%
0/379 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Cardiac disorders
Stressed induced cardiomyopathy
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.00%
0/379 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Nervous system disorders
TIA
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.00%
0/379 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.00%
0/379 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Nervous system disorders
Near syncope due to orthostatic
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.00%
0/379 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary emboli
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.00%
0/379 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.26%
1/378 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
0.26%
1/379 • Number of events 1 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
Other adverse events
| Measure |
Adjuvanted Influenza Vaccine (FLUAD®)
n=378 participants at risk
In the study arm, subjects will receive a single dose of FLUAD® adjuvanted influenza vaccine during Visit 1.
FLUAD®: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
High-dose Influenza Vaccine (Fluzone® HD)
n=379 participants at risk
In the study arm, subjects will receive a single dose of Fluzone® High-Dose influenza vaccine during Visit 1.
Fluzone® High-Dose: Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
4.0%
15/378 • Number of events 15 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
5.0%
19/379 • Number of events 19 • Adverse Events, Serious Adverse Events, and All-Cause Mortality rates were collected 42 days post vaccination. Serious Adverse Events and Mortality Rates were collected up to 181 days for the longer-term immunogenicity subset
The two reported deaths occurred \>42 days post vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place