Trial Outcomes & Findings for The Human Mucosal Immune Responses to Influenza Virus (SLVP026) (NCT NCT03023553)
NCT ID: NCT03023553
Last Updated: 2017-04-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
13 participants
Primary outcome timeframe
Day 0 to 28
Results posted on
2017-04-21
Participant Flow
Participant milestones
| Measure |
TIV/ Control Group
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
LAIV Group
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Human Mucosal Immune Responses to Influenza Virus (SLVP026)
Baseline characteristics by cohort
| Measure |
TIV/ Control Group
n=4 Participants
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
LAIV Group
n=8 Participants
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.99 years
STANDARD_DEVIATION 2.955 • n=99 Participants
|
24.60 years
STANDARD_DEVIATION 5.22 • n=107 Participants
|
24.40 years
STANDARD_DEVIATION 4.45 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28Outcome measures
| Measure |
TIV/ Control Group
n=4 Participants
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
LAIV Group
n=9 Participants
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
|---|---|---|
|
Number of Participants From Each Arm Who Received Influenza Vaccine
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28 post-immunizationOutcome measures
| Measure |
TIV/ Control Group
n=3 Participants
Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection
|
LAIV Group
n=8 Participants
Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
|---|---|---|
|
Number of Participants With Related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
TIV/ Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LAIV Group
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