Trial Outcomes & Findings for Evaluating Immune Response to Seasonal FluMist in Healthy Adults (NCT NCT01673425)
NCT ID: NCT01673425
Last Updated: 2021-01-27
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Change from baseline in antibody titer at 6 weeks
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
Experimental: Live Attenuated Influenza Vaccine
Single intervention study; all participants receive LAIV
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Immune Response to Seasonal FluMist in Healthy Adults
Baseline characteristics by cohort
| Measure |
Live Attenuated Influenza Vaccine Study
n=5 Participants
This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline in antibody titer at 6 weeksPopulation: This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from baseline in serum antibody response at 6 weeksOutcome measures
Outcome data not reported
Adverse Events
Study Enrollment
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
Lewis Radonovich
VA National Center for Occupational Health & Infection Control
Phone: 352-376-1611
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place