Trial Outcomes & Findings for Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (NCT NCT02566265)
NCT ID: NCT02566265
Last Updated: 2019-01-30
Results Overview
Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
1 year
Results posted on
2019-01-30
Participant Flow
Participant milestones
| Measure |
Fluzone High Dose Vaccine Then Fluzone High Dose Booster
Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.
Fluzone High Dose Vaccine
|
Standard of Care
Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.
Standard of care/Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
41
|
|
Overall Study
Day 7 (+/- 2 Days) (Optional)
|
19
|
12
|
|
Overall Study
Day of Second Vaccine
|
74
|
41
|
|
Overall Study
30 Days Following 2nd Vaccine
|
72
|
35
|
|
Overall Study
End of Study Visit (Optional)
|
38
|
18
|
|
Overall Study
COMPLETED
|
72
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Fluzone High Dose Vaccine Then Fluzone High Dose Booster
n=81 Participants
Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.
Fluzone High Dose Vaccine
|
Standard of Care
n=41 Participants
Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.
Standard of care/Placebo
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
n=81 Participants
|
66 years
n=41 Participants
|
67 years
n=122 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=81 Participants
|
18 Participants
n=41 Participants
|
60 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=81 Participants
|
23 Participants
n=41 Participants
|
62 Participants
n=122 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
81 Participants
n=81 Participants
|
41 Participants
n=41 Participants
|
122 Participants
n=122 Participants
|
|
Detailed Diagnosis
Multiple Myeloma
|
53 Participants
n=81 Participants
|
28 Participants
n=41 Participants
|
81 Participants
n=122 Participants
|
|
Detailed Diagnosis
WM
|
6 Participants
n=81 Participants
|
4 Participants
n=41 Participants
|
10 Participants
n=122 Participants
|
|
Detailed Diagnosis
Other
|
3 Participants
n=81 Participants
|
1 Participants
n=41 Participants
|
4 Participants
n=122 Participants
|
|
Detailed Diagnosis
Asymptomatic Myeloma
|
8 Participants
n=81 Participants
|
1 Participants
n=41 Participants
|
9 Participants
n=122 Participants
|
|
Detailed Diagnosis
Asymptomatic WM
|
0 Participants
n=81 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=122 Participants
|
|
Detailed Diagnosis
MGUS
|
11 Participants
n=81 Participants
|
4 Participants
n=41 Participants
|
15 Participants
n=122 Participants
|
|
Disease Stage
Advanced
|
64 Participants
n=81 Participants
|
32 Participants
n=41 Participants
|
96 Participants
n=122 Participants
|
|
Disease Stage
Early
|
17 Participants
n=81 Participants
|
9 Participants
n=41 Participants
|
26 Participants
n=122 Participants
|
PRIMARY outcome
Timeframe: 1 yearAny documented flu infection during the 2015-2016 flu season or evidence of disease progression.
Outcome measures
| Measure |
Fluzone High Dose Vaccine Then Fluzone High Dose Booster
n=81 Participants
Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.
Fluzone High Dose Vaccine
|
Standard of Care
n=41 Participants
Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.
Standard of care/Placebo
|
|---|---|---|
|
Number of Participants With Treatment Failure by Primary Endpoint
|
26 Participants
|
13 Participants
|
Adverse Events
Fluzone High Dose Vaccine Then Fluzone High Dose Booster
Serious events: 8 serious events
Other events: 0 other events
Deaths: 5 deaths
Standard of Care
Serious events: 1 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Fluzone High Dose Vaccine Then Fluzone High Dose Booster
n=81 participants at risk
Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine.
Fluzone High Dose Vaccine
|
Standard of Care
n=41 participants at risk
Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine.
Standard of care/Placebo
|
|---|---|---|
|
Vascular disorders
Intracranial hemorrhage
|
2.5%
2/81 • Number of events 2 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
0.00%
0/41 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.2%
1/81 • Number of events 1 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
0.00%
0/41 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
|
Immune system disorders
Febrile neutropenia
|
2.5%
2/81 • Number of events 2 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
0.00%
0/41 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
|
Infections and infestations
Sepsis
|
0.00%
0/81 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
2.4%
1/41 • Number of events 1 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
|
Vascular disorders
Thromboembolic event
|
2.5%
2/81 • Number of events 2 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
0.00%
0/41 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.2%
1/81 • Number of events 1 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
0.00%
0/41 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
|
Nervous system disorders
Seizure
|
1.2%
1/81 • Number of events 1 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
0.00%
0/41 • Adverse event data were collected up to 12 months after initial vaccination
The definition does not differ.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place