Trial Outcomes & Findings for Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032) (NCT NCT03023709)
NCT ID: NCT03023709
Last Updated: 2017-05-10
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
Day 0
Results posted on
2017-05-10
Participant Flow
The study was halted after the IIV pilot phase because the LAIV vaccine for the study phase was not recommended for use by ACIP so no participants enrolled in the LAIV study phase.
Participant milestones
| Measure |
Pilot Phase (IIV4)
Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering licensed seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular
|
Study Phase (LAIV4)
Participants will be given the quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)
Baseline characteristics by cohort
| Measure |
Pilot Phase (IIV4)
n=3 Participants
Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular
|
Study Phase (LAIV4)
Participants will be given quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
—
|
32 years
STANDARD_DEVIATION 7.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
—
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Study halted after Pilot Phase
Outcome measures
| Measure |
Pilot Phase
n=3 Participants
Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular
|
Study Phase
Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray
|
|---|---|---|
|
Number of Participants Who Received Influenza Vaccine
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 14 post-immunizationOutcome measures
| Measure |
Pilot Phase
n=3 Participants
Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular
|
Study Phase
Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray
|
|---|---|---|
|
Number of Participants With Related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Pilot Phase (IIV4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Phase (LAIV4)
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