Trial Outcomes & Findings for T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010 (NCT NCT03022396)
NCT ID: NCT03022396
Last Updated: 2017-08-21
Results Overview
All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
Day 0 to 28
Results posted on
2017-08-21
Participant Flow
All numbers of participants reflect an individual participant, not a twin pair. All enrollment numbers reflect the number of participants, not the number of twin pairs.
Participant milestones
| Measure |
Group A: Age 8-17 yo Identical Twins
Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group B: Age 18-30 yo Identical Twins
Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group C: Age 18-30 yo Fraternal Twins
Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group D: Age 40 - 59 yo Identical Twins
Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group E: Age 40 - 59 yo Fraternal Twins
Individual Twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group F: Age 70 - 100 yo Identical Twins
Individual Twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
10
|
20
|
14
|
8
|
|
Overall Study
COMPLETED
|
16
|
14
|
10
|
20
|
14
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 2, 2010
Baseline characteristics by cohort
| Measure |
Group A: Age 8-17 yo Identical Twins
n=16 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group B: Age 18-30 yo Identical Twins
n=14 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group C: Age 18-30 yo Fraternal Twins
n=10 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group D: Age 40 - 59 yo Identical Twins
n=20 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group E: Age 40 - 59 yo Fraternal Twins
n=14 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group F: Age 70 - 100 yo Twins
n=8 Participants
Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
13.69 years
STANDARD_DEVIATION 1.88 • n=5 Participants
|
23.71 years
STANDARD_DEVIATION 3.33 • n=7 Participants
|
22.65 years
STANDARD_DEVIATION 2.99 • n=5 Participants
|
53.44 years
STANDARD_DEVIATION 2.25 • n=4 Participants
|
44.52 years
STANDARD_DEVIATION 1.68 • n=21 Participants
|
75.51 years
STANDARD_DEVIATION 4.50 • n=8 Participants
|
37.70 years
STANDARD_DEVIATION 19.94 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
76 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28Population: All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.
All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.
Outcome measures
| Measure |
Group A: Age 8-17 yo Identical Twins
n=16 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group B: Age 18-30 yo Identical Twins
n=14 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group C: Age 18-30 yo Fraternal Twins
n=10 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group D: Age 40 - 59 yo Identical Twins
n=20 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group E: Age 40 - 59 yo Fraternal Twins
n=14 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group F: Age 70 - 100 yo Twins
n=8 Participants
Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
|---|---|---|---|---|---|---|
|
Number of Individual Twins Who Received Influenza Vaccine
|
16 Participants
|
14 Participants
|
10 Participants
|
20 Participants
|
14 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28 post-immunizationOutcome measures
| Measure |
Group A: Age 8-17 yo Identical Twins
n=16 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group B: Age 18-30 yo Identical Twins
n=14 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group C: Age 18-30 yo Fraternal Twins
n=10 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group D: Age 40 - 59 yo Identical Twins
n=20 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group E: Age 40 - 59 yo Fraternal Twins
n=14 Participants
Individual twins to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
Group F: Age 70 - 100 yo Twins
n=8 Participants
Individual twins to receive Fluzone® (intramuscular) or High Dose Fluzone® (intramuscular)
High Dose Fluzone® (intramuscular): Licensed seasonal High dose trivalent inactivated influenza
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza
|
|---|---|---|---|---|---|---|
|
Number of Individual Twins With Related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group A: Age 8-17 yo Identical Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: Age 18-30 yo Identical Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C: Age 18-30 yo Fraternal Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D: Age 40 - 59 yo Identical Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group E: Age 40 - 59 yo Fraternal Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group F: Age 70 - 100 yo Identical 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