Trial Outcomes & Findings for Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age (NCT NCT03020472)
NCT ID: NCT03020472
Last Updated: 2021-10-18
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Day 0 to Day 28
Results posted on
2021-10-18
Participant Flow
Participant milestones
| Measure |
2008-2009 FluMist LAIV (Intranasal)
Seasonal live, attenuated influenza vaccine (LAIV)
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age
Baseline characteristics by cohort
| Measure |
2008-2009 FluMist LAIV (Intranasal)
n=6 Participants
2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally
|
|---|---|
|
Age, Continuous
|
2.4 years
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 28Outcome measures
| Measure |
2008-2009 FluMist LAIV (Intranasal)
n=6 Participants
2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally
|
|---|---|
|
Number of Participants Who Received Influenza Vaccine
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 28Outcome measures
| Measure |
2008-2009 FluMist LAIV (Intranasal)
n=6 Participants
2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally
|
|---|---|
|
Number of Participants With Related Adverse Events
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5-13 days post immunizationPopulation: Due to the low enrollment, the study was terminated and analysis was not performed.
Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 to Day 28Outcome measures
Outcome data not reported
Adverse Events
2008-2009 FluMist LAIV (Intranasal)
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