Trial Outcomes & Findings for Self-Administered Nasal Influenza Feasibility Study (NCT NCT01933048)
NCT ID: NCT01933048
Last Updated: 2023-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1077 participants
Primary outcome timeframe
28+/- 7 days post-vaccination
Results posted on
2023-02-15
Participant Flow
Recruitment and enrollment was conducted in San Antonio, Texas and San Diego, California.
Participant milestones
| Measure |
Healthcare Worker Administration (HCWA)
FluMist administered by a Healthcare Worker
|
Self-Administration (SA)
FluMist self-administered by subject
|
|---|---|---|
|
Overall Study
STARTED
|
548
|
529
|
|
Overall Study
COMPLETED
|
523
|
501
|
|
Overall Study
NOT COMPLETED
|
25
|
28
|
Reasons for withdrawal
| Measure |
Healthcare Worker Administration (HCWA)
FluMist administered by a Healthcare Worker
|
Self-Administration (SA)
FluMist self-administered by subject
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
18
|
|
Overall Study
personal reasons
|
1
|
1
|
|
Overall Study
Protocol Violation
|
7
|
8
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
unknown reasons
|
1
|
1
|
Baseline Characteristics
Self-Administered Nasal Influenza Feasibility Study
Baseline characteristics by cohort
| Measure |
Healthcare Worker Administration
n=523 Participants
FluMist administered by a Healthcare Worker
|
Self-Administration
n=501 Participants
FluMist self-administered by subject
|
Total
n=1024 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
n=5 Participants
|
28 years
n=7 Participants
|
29 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
157 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
366 Participants
n=5 Participants
|
360 Participants
n=7 Participants
|
726 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
103 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
420 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
820 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
88 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
332 Participants
n=5 Participants
|
347 Participants
n=7 Participants
|
679 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
103 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
523 participants
n=5 Participants
|
501 participants
n=7 Participants
|
1024 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28+/- 7 days post-vaccinationOutcome measures
| Measure |
Healthcare Worker Administration
n=523 Participants
FluMist administered by a Healthcare Worker
|
Self-Administration
n=501 Participants
FluMist self-administered by subject
|
|---|---|---|
|
Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
A/H1N1
|
45.8 titer ratio
Interval 41.1 to 51.1
|
48.7 titer ratio
Interval 43.6 to 54.5
|
|
Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
A/H3N2
|
45.5 titer ratio
Interval 40.8 to 50.6
|
46.4 titer ratio
Interval 41.6 to 51.8
|
|
Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
B/Yamagata
|
17.2 titer ratio
Interval 15.9 to 18.6
|
17.8 titer ratio
Interval 16.5 to 19.2
|
|
Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects
B/Brisbane (2013-2014 only; HCWA n=346; SA n=359)
|
16.2 titer ratio
Interval 14.7 to 17.9
|
14.7 titer ratio
Interval 13.3 to 16.2
|
SECONDARY outcome
Timeframe: 28+/- 7 days post-vaccinationOutcome measures
| Measure |
Healthcare Worker Administration
n=523 Participants
FluMist administered by a Healthcare Worker
|
Self-Administration
n=501 Participants
FluMist self-administered by subject
|
|---|---|---|
|
Difference and Proportion in Seroresponse of Subjects
A/H1N1
|
340 participants
|
344 participants
|
|
Difference and Proportion in Seroresponse of Subjects
A/H3N2
|
335 participants
|
336 participants
|
|
Difference and Proportion in Seroresponse of Subjects
B/Yamagata
|
141 participants
|
137 participants
|
|
Difference and Proportion in Seroresponse of Subjects
B/Brisbane (2013-2014 only; HCWA n=346; SA n=359)
|
84 participants
|
79 participants
|
SECONDARY outcome
Timeframe: 28+/- 7 days post-vaccinationOutcome measures
| Measure |
Healthcare Worker Administration
n=523 Participants
FluMist administered by a Healthcare Worker
|
Self-Administration
n=501 Participants
FluMist self-administered by subject
|
|---|---|---|
|
Difference and Proportion in Seroconversion of Subjects
A/H1N1
|
15 participants
|
5 participants
|
|
Difference and Proportion in Seroconversion of Subjects
A/H3N2
|
8 participants
|
7 participants
|
|
Difference and Proportion in Seroconversion of Subjects
B/Yamagata
|
2 participants
|
3 participants
|
|
Difference and Proportion in Seroconversion of Subjects
B/Brisbane (2013-2014 only; HCWA n=346; SA n=359)
|
23 participants
|
14 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28+/- 7 days post-vaccinationOutcome measures
| Measure |
Healthcare Worker Administration
n=523 Participants
FluMist administered by a Healthcare Worker
|
Self-Administration
n=501 Participants
FluMist self-administered by subject
|
|---|---|---|
|
Feasibility of Self-administration Prior to Vaccine Administration
HCWA preferred method
|
71 participants
|
65 participants
|
|
Feasibility of Self-administration Prior to Vaccine Administration
SA preferred method
|
132 participants
|
129 participants
|
|
Feasibility of Self-administration Prior to Vaccine Administration
No preference
|
320 participants
|
307 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28+/- 7 days post-vaccinationPopulation: Numbers include participants randomized to the SA group only.
Outcome measures
| Measure |
Healthcare Worker Administration
n=501 Participants
FluMist administered by a Healthcare Worker
|
Self-Administration
FluMist self-administered by subject
|
|---|---|---|
|
Feasibility of Self-administration Following Vaccine Administration
HCWA preferred method
|
29 participants
|
—
|
|
Feasibility of Self-administration Following Vaccine Administration
SA preferred method
|
319 participants
|
—
|
|
Feasibility of Self-administration Following Vaccine Administration
No preference
|
153 participants
|
—
|
Adverse Events
Healthcare Worker Administration
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Self-Administration
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Healthcare Worker Administration
n=548 participants at risk
This group includes healthcare worker administration of FluMist to subjects.
|
Self-Administration
n=529 participants at risk
This group includes subjects who self-administered FluMist.
|
|---|---|---|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/548 • 2 years
|
0.19%
1/529 • Number of events 1 • 2 years
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/548 • 2 years
|
0.19%
1/529 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.18%
1/548 • Number of events 1 • 2 years
|
0.00%
0/529 • 2 years
|
|
Hepatobiliary disorders
Cholecystectomy
|
0.00%
0/548 • 2 years
|
0.19%
1/529 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Hernia
|
0.18%
1/548 • Number of events 1 • 2 years
|
0.00%
0/529 • 2 years
|
Other adverse events
| Measure |
Healthcare Worker Administration
n=548 participants at risk
This group includes healthcare worker administration of FluMist to subjects.
|
Self-Administration
n=529 participants at risk
This group includes subjects who self-administered FluMist.
|
|---|---|---|
|
Surgical and medical procedures
Syncope
|
0.00%
0/548 • 2 years
|
0.38%
2/529 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal and chest congestion
|
0.36%
2/548 • Number of events 2 • 2 years
|
0.95%
5/529 • Number of events 5 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitus
|
0.18%
1/548 • Number of events 1 • 2 years
|
0.00%
0/529 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.18%
1/548 • Number of events 1 • 2 years
|
0.57%
3/529 • Number of events 3 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough and sore throat
|
0.73%
4/548 • Number of events 4 • 2 years
|
0.95%
5/529 • Number of events 5 • 2 years
|
|
General disorders
Headache
|
0.00%
0/548 • 2 years
|
0.57%
3/529 • Number of events 3 • 2 years
|
|
General disorders
Tiredness and weakness
|
0.36%
2/548 • Number of events 2 • 2 years
|
0.57%
3/529 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Nausea and diarrhea
|
0.36%
2/548 • Number of events 2 • 2 years
|
0.19%
1/529 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.18%
1/548 • Number of events 1 • 2 years
|
0.00%
0/529 • 2 years
|
|
General disorders
Pain
|
0.00%
0/548 • 2 years
|
0.38%
2/529 • Number of events 2 • 2 years
|
Additional Information
Eugene V. Millar, PhD
Uniformed Services University of the Health Sciences
Phone: 301-816-8451
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place