Trial Outcomes & Findings for B-cell Immunity to Influenza (SLVP017)- Year 1, 2009 (NCT NCT02133781)
NCT ID: NCT02133781
Last Updated: 2018-06-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
Day 0 to 28
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Age 8-17 Years (Identical Twins )
Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally
|
Age 18-30 Years (Non-twins)
Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
Age > 70 Years (Non-twins)
Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
24
|
21
|
|
Overall Study
COMPLETED
|
6
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
B-cell Immunity to Influenza (SLVP017)- Year 1, 2009
Baseline characteristics by cohort
| Measure |
Age 8-17 Years (Identical Twins )
n=6 Participants
Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally
|
Age 18-30 Years (Non-twins)
n=24 Participants
Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
Age > 70 Years (Non-twins)
n=21 Participants
Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
24 participants
n=107 Participants
|
21 participants
n=206 Participants
|
51 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28Outcome measures
| Measure |
Age 8-17 Years (Identical Twins )
n=6 Participants
Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally
|
Age 18-30 Years (Non-twins)
n=24 Participants
Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
Age > 70 Years (Non-twins)
n=21 Participants
Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
|---|---|---|---|
|
Number of Participants From Each Arm Who Received Influenza Vaccine
|
6 Participants
|
24 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28 post-immunizationOutcome measures
| Measure |
Age 8-17 Years (Identical Twins )
n=6 Participants
Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
Flumist® 2009-2010 Formula: This vaccine is given intranasally
|
Age 18-30 Years (Non-twins)
n=24 Participants
Participants will be receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
Age > 70 Years (Non-twins)
n=21 Participants
Participants will receive Fluzone® 2009-2010 Formula
Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly
|
|---|---|---|---|
|
Number of Participants With Related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to 28Outcome measures
Outcome data not reported
Adverse Events
Age 8-17 Years (Identical Twins )
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Age 18-30 Years (Non-twins)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Age > 70 Years (Non-twins)
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
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