Trial Outcomes & Findings for Senescent Immunity in Elders and Vaccine Responses (SILVER) (NCT NCT04077424)
NCT ID: NCT04077424
Last Updated: 2022-07-12
Results Overview
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
Baseline Baseline
Results posted on
2022-07-12
Participant Flow
Participant milestones
| Measure |
Fluzone-High Dose
FDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group.
|
Fluad
Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Fluad: Adjuvanted (MF59) inactivated influenza vaccine
|
Recombinant Hemagglutinin Vaccine (Flublok)
Recombinant hemagglutinin vaccine
Flublock: Recombinant hemagglutinin vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
6
|
|
Overall Study
COMPLETED
|
2
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Senescent Immunity in Elders and Vaccine Responses (SILVER)
Baseline characteristics by cohort
| Measure |
Fluzone-High Dose
n=2 Participants
FDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group.
|
Fluad
n=2 Participants
Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Fluad: Adjuvanted (MF59) inactivated influenza vaccine
|
Recombinant Hemagglutinin Vaccine (Flublok)
n=6 Participants
Recombinant hemagglutinin vaccine
Flublock: Recombinant hemagglutinin vaccine
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
10 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline BaselinePopulation: 1 person in Fluzone HD group received vaccine, but did not return for subsequent visits, so titers were not performed for this participant.
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Outcome measures
| Measure |
Fluzone-High Dose
n=2 Participants
FDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group.
|
Fluad
n=2 Participants
Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Fluad: Adjuvanted (MF59) inactivated influenza vaccine
|
Recombinant Hemagglutinin Vaccine (Flublok)
n=6 Participants
Recombinant hemagglutinin vaccine
Flublock: Recombinant hemagglutinin vaccine
|
|---|---|---|---|
|
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
A/Brisbane/2018 (H1N1)
|
20 antibody titers
Interval 20.0 to 20.0
|
160 antibody titers
Interval 160.0 to 160.0
|
25 antibody titers
Interval 10.0 to 50.0
|
|
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
A/Kansas/2017 (H3N2)
|
40 antibody titers
Interval 40.0 to 40.0
|
90 antibody titers
Interval 20.0 to 160.0
|
50 antibody titers
Interval 10.0 to 160.0
|
|
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
B/Colorado/2017 (Vic)
|
160 antibody titers
Interval 160.0 to 160.0
|
240 antibody titers
Interval 160.0 to 320.0
|
120 antibody titers
Interval 70.0 to 200.0
|
|
Hemagglutinin Antigen Inhibition Assay Titers at Baseline
B/Phuket/2013 (Yam)
|
320 antibody titers
Interval 320.0 to 320.0
|
160 antibody titers
Interval 160.0 to 160.0
|
100 antibody titers
Interval 35.0 to 280.0
|
PRIMARY outcome
Timeframe: Day 28 BaselinePopulation: 1 person in Fluzone HD group received vaccine, but did not return for subsequent visits, so titers were not performed for this participant.
2 fold dilution series of serum, and measurement of titer which inhibits hemagglutination. Titers were measured for each of 4 antigens in the vaccine (A/Brisbane/2018 (H1N1), A/Kansas/2017 (H3N2), B/Colorado/2017 (Vic), B/Phuket/2013 (Yam))
Outcome measures
| Measure |
Fluzone-High Dose
n=2 Participants
FDA approved high dose inactivated influenza vaccine (HD-Fluzone)
Fluzone-High Dose Quadrivalent: Seasonal influenza vaccination with FDA approved vaccines for this age group.
|
Fluad
n=2 Participants
Adjuvanted (MF59) inactivated influenza vaccine (Fluad)
Fluad: Adjuvanted (MF59) inactivated influenza vaccine
|
Recombinant Hemagglutinin Vaccine (Flublok)
n=6 Participants
Recombinant hemagglutinin vaccine
Flublock: Recombinant hemagglutinin vaccine
|
|---|---|---|---|
|
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
A/Brisbane/2018 (H1N1)
|
320 antibody titers
Interval 320.0 to 320.0
|
120 antibody titers
Interval 70.0 to 440.0
|
480 antibody titers
Interval 320.0 to 640.0
|
|
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
A/Kansas/2017 (H3N2)
|
2560 antibody titers
Interval 2560.0 to 2560.0
|
160 antibody titers
Interval 160.0 to 160.0
|
320 antibody titers
Interval 280.0 to 1120.0
|
|
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
B/Colorado/2017 (Vic)
|
640 antibody titers
Interval 640.0 to 640.0
|
320 antibody titers
Interval 140.0 to 560.0
|
480 antibody titers
Interval 320.0 to 640.0
|
|
Hemagglutinin Antigen Inhibition Assay Titers at Day 28
B/Phuket/2013 (Yam)
|
320 antibody titers
Interval 320.0 to 320.0
|
160 antibody titers
Interval 160.0 to 160.0
|
240 antibody titers
Interval 140.0 to 640.0
|
Adverse Events
Fluzone-High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluad
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Recombinant Hemagglutinin Vaccine (Flublok)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place