Trial Outcomes & Findings for Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP024) (NCT NCT03023683)
NCT ID: NCT03023683
Last Updated: 2021-10-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
Day 0 to 28
Results posted on
2021-10-18
Participant Flow
Participant milestones
| Measure |
Group A: 2-8 yo Healthy Non-twins
Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
Group B: 18-49 yo Healthy Non-twins
Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
18
|
|
Overall Study
COMPLETED
|
0
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP024)
Baseline characteristics by cohort
| Measure |
Group A: 2-8 yo Healthy Non-twins
Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
Group B: 18-49 yo Healthy Non-twins
n=18 Participants
Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
28.07 years
STANDARD_DEVIATION 8.09 • n=107 Participants
|
28.07 years
STANDARD_DEVIATION 8.09 • n=206 Participants
|
|
Sex: Female, Male
Female
|
—
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
—
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
18 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
—
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
18 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 28Outcome measures
| Measure |
Group A: 2-8 yo Healthy Non-twins
Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
Group B: 18-49 yo Healthy Non-twins
n=18 Participants
Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
|---|---|---|
|
Number of Participants From Each Arm Who Received Influenza Vaccine
|
0 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 28 post-immunizationOutcome measures
| Measure |
Group A: 2-8 yo Healthy Non-twins
Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
Group B: 18-49 yo Healthy Non-twins
n=17 Participants
Participants will be given seasonal LAIV, FluMist® .
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray
|
|---|---|---|
|
Number of Participants With Related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Group A: 2-8 yo Healthy Non-twins
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B: 18-49 yo Healthy 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