Trial Outcomes & Findings for Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014) (NCT NCT02141581)
NCT ID: NCT02141581
Last Updated: 2018-05-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
86 participants
Primary outcome timeframe
Baseline to Day 28
Results posted on
2018-05-07
Participant Flow
Participant milestones
| Measure |
Group A Fluzone® (IM)
Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
|
Group B Fluzone® (ID)
Participants in this group will be randomized to Fluzone® administered intradermally (ID)
|
Group C FluMist®
Participants in this group will be randomized to FluMist® administered intranasally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
19
|
25
|
|
Overall Study
COMPLETED
|
42
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014)
Baseline characteristics by cohort
| Measure |
Group A Fluzone® (IM)
n=42 Participants
Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
|
Group B Fluzone® (ID)
n=19 Participants
Participants in this group will be randomized to Fluzone® administered intradermally (ID)
|
Group C FluMist®
n=25 Participants
Participants in this group will be randomized to FluMist® administered intranasally.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age 18-30 years
|
32 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Age, Customized
Age 8-17 years
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
79 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 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
|
25 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28Outcome measures
| Measure |
Group A Fluzone® (IM)
n=42 Participants
Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
|
Group B Fluzone® (ID)
n=19 Participants
Participants in this group will be randomized to Fluzone® administered intradermally (ID)
|
Group C Flumist®
n=25 Participants
Participants in this group will be randomized to Flumist® administered intranasally.
|
|---|---|---|---|
|
Number of Participants From Each Arm Who Received Influenza Vaccine
|
42 Participants
|
19 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 28Number of participants with Related Adverse Events with a 0% Frequency Threshold
Outcome measures
| Measure |
Group A Fluzone® (IM)
n=42 Participants
Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
|
Group B Fluzone® (ID)
n=19 Participants
Participants in this group will be randomized to Fluzone® administered intradermally (ID)
|
Group C Flumist®
n=25 Participants
Participants in this group will be randomized to Flumist® administered intranasally.
|
|---|---|---|---|
|
Number of Participants With Related Adverse Events
Bronchospasm
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Related Adverse Events
Erythema at injection site
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Related Adverse Events
No Related Adverse Events
|
40 Participants
|
19 Participants
|
25 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 7Outcome measures
Outcome data not reported
Adverse Events
Group A Fluzone® (IM)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group B Fluzone® (ID)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group C FluMist®
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A Fluzone® (IM)
n=42 participants at risk
Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
|
Group B Fluzone® (ID)
n=19 participants at risk
Participants in this group will be randomized to Fluzone® administered intradermally (ID)
|
Group C FluMist®
n=25 participants at risk
Participants in this group will be randomized to FluMist® administered intranasally.
|
|---|---|---|---|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/42
|
0.00%
0/19
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.4%
1/42 • Number of events 1
|
0.00%
0/19
|
0.00%
0/25
|
Other adverse events
| Measure |
Group A Fluzone® (IM)
n=42 participants at risk
Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
|
Group B Fluzone® (ID)
n=19 participants at risk
Participants in this group will be randomized to Fluzone® administered intradermally (ID)
|
Group C FluMist®
n=25 participants at risk
Participants in this group will be randomized to FluMist® administered intranasally.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.4%
1/42 • Number of events 1
|
0.00%
0/19
|
0.00%
0/25
|
|
General disorders
Erythema at injection site
|
0.00%
0/42
|
5.3%
1/19 • Number of events 1
|
0.00%
0/25
|
|
Nervous system disorders
Presyncope
|
4.8%
2/42 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
Additional Information
Dr Cornelia Dekker
Stanford University School of Medicine, Dept. of Pediatrics
Phone: 650-724-4437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place