Trial Outcomes & Findings for T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009 (NCT NCT01987349)
NCT ID: NCT01987349
Last Updated: 2017-05-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
Day 0 to 28
Results posted on
2017-05-12
Participant Flow
Numbers listed in the tables reflect individual twins and not twin pairs.
Participant milestones
| Measure |
Group A: Age 8-17 yo Identical Twins
Participants will be randomized to receive Fluzone® (intramuscular)
|
Group A: Age 8-17yo Identical Twins
Participants will be randomized to receive FluMist® (intranasal)
|
Group B: Age 18-30 yo Identical Twins
Participants to receive FluMist® (intranasal)
|
Group C: Age 18-30 yo Fraternal Twins
Participants to receive FluMist® (intranasal)
|
Group D: Age 40-49 yo Identical Twins
Participants to receive FluMist® (intranasal)
|
Group E: Age 40-49 yo Fraternal Twins
Participants to receive FluMist® (intranasal)
|
Group F: 70-100 yo Identical Twins
Participants to receive Fluzone® (intramuscular)
|
Group G: 70-100 yo Nontwins
Participants to receive Fluzone® (intramuscular)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
8
|
6
|
6
|
6
|
10
|
25
|
|
Overall Study
COMPLETED
|
6
|
6
|
8
|
6
|
6
|
6
|
10
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) - Year 1, 2009
Baseline characteristics by cohort
| Measure |
Group A: Age 8-17 yo Identical Twins (Fluzone)
n=6 Participants
Participants will be randomized to receive Fluzone® (intramuscular)
|
Group A: Age 8-17 yo Identical Twins (FluMist)
n=6 Participants
Participants will be randomized to receive FluMist® (intranasal)
|
Group B: Age 18-30 yo Identical Twins
n=8 Participants
Participants to receive FluMist® (intranasal)
|
Group C: Age 18-30 yo Fraternal Twins
n=6 Participants
Participants to receive FluMist® (intranasal)
|
Group D: Age 40-49 yo Identical Twins
n=6 Participants
Participants to receive FluMist® (intranasal)
|
Group E: Age 40-49 yo Fraternal Twins
n=6 Participants
Participants to receive FluMist® (intranasal)
|
Group F: 70-100 yo Identical Twins
n=10 Participants
Participants to receive Fluzone® (intramuscular)
|
Group G: 70-100 yo Nontwins
n=24 Participants
Participants to receive Fluzone® (intramuscular)
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
12 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
26 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
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=10 Participants
|
10 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
34 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
18 Participants
n=6 Participants
|
42 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
68 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 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
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 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
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
65 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28Outcome measures
| Measure |
Group A: Age 8-17 yo Identical Twins (IM)
n=6 Participants
Participants will be randomized to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
|
Group A: Age 8-17 yo Identical Twins (IN)
n=6 Participants
Participants will be randomized to receive FluMist® (intranasal
FluMist®: Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group B: 18-30 yo Identical Twins
n=8 Participants
Participants to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group C: 18-30 yo Fraternal Twins
n=6 Participants
Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group D: 40-49 yo Identical Twins
n=6 Participants
Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group E: 40-49 yo Fraternal Twins
n=6 Participants
Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group F: 70-100 yo Twins
n=10 Participants
Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
|
Group G: 70-100 yo Non-twins
n=24 Participants
Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine
|
6 Participants
|
6 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28 post-immunizationOutcome measures
| Measure |
Group A: Age 8-17 yo Identical Twins (IM)
n=6 Participants
Participants will be randomized to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
|
Group A: Age 8-17 yo Identical Twins (IN)
n=6 Participants
Participants will be randomized to receive FluMist® (intranasal
FluMist®: Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group B: 18-30 yo Identical Twins
n=8 Participants
Participants to receive FluMist® (intranasal)
FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group C: 18-30 yo Fraternal Twins
n=6 Participants
Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group D: 40-49 yo Identical Twins
n=6 Participants
Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group E: 40-49 yo Fraternal Twins
n=6 Participants
Participants to receive Flumist® (intranasal)
Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
|
Group F: 70-100 yo Twins
n=10 Participants
Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
|
Group G: 70-100 yo Non-twins
n=24 Participants
Participants to receive Fluzone® (intramuscular)
Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Related Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 6-28 post-immunizationCompare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines
Outcome measures
Outcome data not reported
Adverse Events
Group A: Age 8-17 yo Identical Twins (Fluzone)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group A: Age 8-17 yo Identical Twins (Flumist)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: 18-30 yo Identical Twin Pairs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C: 18-30 yo Fraternal Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D: 40-49 yo Identical Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group E: 40-49 yo Fraternal Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group F: 70-100 yo Twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group G: 70-100 yo 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