Trial Outcomes & Findings for FLUAD vs. FLUZONE HD Influenza Vaccine in Residents of Long Term Care (NCT NCT03694808)
NCT ID: NCT03694808
Last Updated: 2024-04-30
Results Overview
HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.
COMPLETED
PHASE4
478 participants
1 month post vaccine administration
2024-04-30
Participant Flow
19 people were excluded prior to assignment to a group. People were excluded from the study if investigators failed to obtain all proper documentation on time (HIPPA, consent), if they withdrew consent, already got vaccine elsewhere, on antibiotics, ivermectin, refused vaccination, were hospitalized, left the facility prior to study completion for any reason.
Participant milestones
| Measure |
Fluad Vaccine
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Study
STARTED
|
240
|
219
|
|
Overall Study
COMPLETED
|
194
|
193
|
|
Overall Study
NOT COMPLETED
|
46
|
26
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex was not reported on 2 people in the Fluad vaccine group.
Baseline characteristics by cohort
| Measure |
Fluad Vaccine
n=194 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=193 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
Total
n=387 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.5 Years
STANDARD_DEVIATION 9.8 • n=194 Participants
|
80.6 Years
STANDARD_DEVIATION 9.3 • n=193 Participants
|
80 Years
STANDARD_DEVIATION 9.6 • n=387 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=192 Participants • Sex was not reported on 2 people in the Fluad vaccine group.
|
93 Participants
n=193 Participants • Sex was not reported on 2 people in the Fluad vaccine group.
|
195 Participants
n=385 Participants • Sex was not reported on 2 people in the Fluad vaccine group.
|
|
Sex: Female, Male
Male
|
90 Participants
n=192 Participants • Sex was not reported on 2 people in the Fluad vaccine group.
|
100 Participants
n=193 Participants • Sex was not reported on 2 people in the Fluad vaccine group.
|
190 Participants
n=385 Participants • Sex was not reported on 2 people in the Fluad vaccine group.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=194 Participants
|
5 Participants
n=193 Participants
|
8 Participants
n=387 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=194 Participants
|
181 Participants
n=193 Participants
|
364 Participants
n=387 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=194 Participants
|
7 Participants
n=193 Participants
|
15 Participants
n=387 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=194 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=194 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=194 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=194 Participants
|
21 Participants
n=193 Participants
|
48 Participants
n=387 Participants
|
|
Race (NIH/OMB)
White
|
156 Participants
n=194 Participants
|
161 Participants
n=193 Participants
|
317 Participants
n=387 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=194 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=387 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=194 Participants
|
11 Participants
n=193 Participants
|
22 Participants
n=387 Participants
|
PRIMARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.
Outcome measures
| Measure |
Fluad Vaccine
n=192 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=190 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Hemagglutinin Inhibition (HAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
213.4 Titer
Interval 156.9 to 290.4
|
261.9 Titer
Interval 192.3 to 356.6
|
|
Overall Hemagglutinin Inhibition (HAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
70.5 Titer
Interval 53.5 to 92.9
|
67.2 Titer
Interval 52.3 to 86.3
|
PRIMARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.
Outcome measures
| Measure |
Fluad Vaccine
n=194 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=193 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Hemagglutinin Inhibition (HAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
375.5 Titer
Interval 271.3 to 519.7
|
517.3 Titer
Interval 380.8 to 702.6
|
|
Overall Hemagglutinin Inhibition (HAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
140.2 Titer
Interval 96.9 to 202.7
|
120.4 Titer
Interval 87.2 to 166.2
|
PRIMARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.
Outcome measures
| Measure |
Fluad Vaccine
n=194 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=193 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Hemagglutinin Inhibition (HAI) B Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
113.6 Titer
Interval 87.6 to 146.8
|
210.4 Titer
Interval 152.5 to 290.3
|
|
Overall Hemagglutinin Inhibition (HAI) B Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
75.5 Titer
Interval 58.1 to 98.1
|
66.1 Titer
Interval 51.1 to 85.5
|
PRIMARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.
Outcome measures
| Measure |
Fluad Vaccine
n=192 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=190 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall HAI H1N1 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
29.2 percentage of participants
Interval 20.3 to 40.0
|
44.6 percentage of participants
Interval 33.8 to 55.9
|
|
Overall HAI H1N1 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
48.5 percentage of participants
Interval 38.7 to 58.5
|
43 percentage of participants
Interval 33.6 to 52.9
|
PRIMARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.
Outcome measures
| Measure |
Fluad Vaccine
n=194 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=193 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall HAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
35.2 percentage of participants
Interval 25.6 to 46.0
|
57 percentage of participants
Interval 45.9 to 67.5
|
|
Overall HAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
70.9 percentage of participants
Interval 61.0 to 79.2
|
70.1 percentage of participants
Interval 60.4 to 78.4
|
PRIMARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
HAI is an in vitro bioassay testing subjects' sera for specific anti-influenza antibodies to each strain in the vaccine. Seroconversion is 4-fold rise in antibody titer. The FDA uses this as the standard immunogenicity assay for licensure. The investigators will follow the guidelines set out in the FDA guidance document on non-inferiority immunogenicity studies for the analysis plan.
Outcome measures
| Measure |
Fluad Vaccine
n=194 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=193 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall HAI B Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
34.1 percentage of participants
Interval 24.7 to 44.8
|
47.7 percentage of participants
Interval 36.9 to 58.7
|
|
Overall HAI B Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
36.9 percentage of participants
Interval 27.8 to 47.0
|
39.3 percentage of participants
Interval 30.1 to 49.2
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
Neuraminidase inhibition (NAI) assays will be performed to measure anti-neuraminidase titers. Seroconversion is 4-fold rise in antibody titer.
Outcome measures
| Measure |
Fluad Vaccine
n=192 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=189 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Neuraminidase Inhibition (NAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
167.7 Titer
Interval 128.2 to 219.3
|
71.8 Titer
Interval 53.0 to 97.3
|
|
Overall Neuraminidase Inhibition (NAI) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
666.4 Titer
Interval 497.7 to 892.3
|
297.8 Titer
Interval 214.3 to 413.8
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
Neuraminidase inhibition (NAI) assays will be performed to measure anti-neuraminidase titers. Seroconversion is 4-fold rise in antibody titer.
Outcome measures
| Measure |
Fluad Vaccine
n=194 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=192 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Neuraminidase Inhibition (NAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
27.3 Titer
Interval 23.3 to 32.1
|
24.9 Titer
Interval 20.6 to 30.1
|
|
Overall Neuraminidase Inhibition (NAI) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
46.7 Titer
Interval 37.1 to 58.8
|
44.7 Titer
Interval 35.4 to 56.4
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
Neuraminidase inhibition (NAI) assays will be performed to measure anti-neuraminidase titers. Seroconversion is 4-fold rise in antibody titer.
Outcome measures
| Measure |
Fluad Vaccine
n=192 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=189 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall H1N1 NAI Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
64 percentage of participants
Interval 53.1 to 73.7
|
9.6 percentage of participants
Interval 4.6 to 18.6
|
|
Overall H1N1 NAI Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
60.2 percentage of participants
Interval 50.1 to 69.6
|
43.4 percentage of participants
Interval 33.9 to 53.4
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: The total number analyzed represents the overall number of participants per group analyzed for both years combined. The total number analyzed per year is represented in the row value.
Neuraminidase inhibition (NAI) assays will be performed to measure anti-neuraminidase titers. Seroconversion is 4-fold rise in antibody titer.
Outcome measures
| Measure |
Fluad Vaccine
n=194 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=192 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall NAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 1 (2018-2019)
|
20.9 percentage of participants
Interval 13.3 to 30.9
|
10.5 percentage of participants
Interval 5.2 to 19.4
|
|
Overall NAI H3N2 Seroconversion Rate Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
Year 2 (2019-2020)
|
32 percentage of participants
Interval 23.4 to 42.1
|
20.8 percentage of participants
Interval 13.7 to 29.9
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: SVN assay was only performed on samples for the 2018-2019 flu season. The 2019-2020 assays were not performed due to interruption by SARS-Cov-2 pandemic.
Serum virus neutralization (SVN) assays will be performed to measure the ability of serum to inhibit influenza infection.
Outcome measures
| Measure |
Fluad Vaccine
n=65 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=67 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Serum Virus Neutralization (SVN) H1N1 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
|
675.7 Titer
Interval 532.2 to 872.7
|
791.3 Titer
Interval 647.7 to 966.7
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: No data was collected
Hemagglutinin inhibition (HAI), neuraminidase inhibition (NAI) assays and serum virus neutralization (SVN) assays will be performed with heterologous A/H3N2 strains to determine if Fluad has an increased breadth of both B and T cell responses as would be predicted from an adjuvanted vaccine.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: SVN assay was only performed on samples for the 2018-2019 flu season. The 2019-2020 assays were not performed due to interruption by SARS-Cov-2 pandemic.
Serum virus neutralization (SVN) assays will be performed to measure the ability of serum to inhibit influenza infection.
Outcome measures
| Measure |
Fluad Vaccine
n=66 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=65 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Serum Virus Neutralization (SVN) H3N2 Titer Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
|
270.8 Titer
Interval 180.0 to 407.3
|
405.0 Titer
Interval 279.9 to 586.0
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: SVN assay was only performed on samples for the 2018-2019 flu season. The 2019-2020 assays were not performed due to interruption by SARS-Cov-2 pandemic.
Serum virus neutralization (SVN) assays will be performed to measure the ability of serum to inhibit influenza infection.
Outcome measures
| Measure |
Fluad Vaccine
n=65 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=67 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Serum Virus Neutralization (SVN) H1N1 Seroconversion Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
|
32.3 percentage of participants
Interval 21.5 to 45.2
|
31.3 percentage of participants
Interval 20.9 to 44.0
|
SECONDARY outcome
Timeframe: 1 month post vaccine administrationPopulation: SVN assay was only performed on samples for the 2018-2019 flu season. The 2019-2020 assays were not performed due to interruption by SARS-Cov-2 pandemic.
Serum virus neutralization (SVN) assays will be performed to measure the ability of serum to inhibit influenza infection.
Outcome measures
| Measure |
Fluad Vaccine
n=66 Participants
A single adjuvanted dose (AD) intramuscular injection
Fluad Vaccine: single adjuvanted dose (AD) intramuscular injection
|
Fluzone Vaccine
n=65 Participants
A single high dose (HD) intramuscular injection
Fluzone HD Vaccine: single high dose (HD) intramuscular injection
|
|---|---|---|
|
Overall Serum Virus Neutralization (SVN) H3N2 Seroconversion Between FLUAD and FLUZONE HD at 1 Month Post-vaccination.
|
21.2 percentage of participants
Interval 12.5 to 33.3
|
43.1 percentage of participants
Interval 31.1 to 55.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-8 months post vaccine administrationPopulation: No data collected
A record review and a blood 2 weeks after the influenza season is over will be done. From a record review the dates and diagnoses of hospitalizations and/or "influenza like illness" (ILI) will be recorded. Serologic evidence of influenza infection ( \>=4-fold titer rise beyond the post-vaccine titers) will be determined from the remote blood draw. An exploratory analysis will be performed comparing the efficacy of the two vaccines.
Outcome measures
Outcome data not reported
Adverse Events
Fluad Vaccine
Fluzone Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Canaday
University Hospitals Cleveland Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place