Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2U19AI057229-11 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Due to the ACIP guidelines halting the use of LAIV
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators collected blood and lymphoid tissues routinely discarded during surgery from adults after a routine seasonal influenza vaccination to determine how immune memory develops at the actual site of infection, and how immunization may alter this process.
This is a Phase IV study of licensed influenza vaccines with up to 30 male and female adults, 18-49 years of age that was halted due to the recommendation that live, attenuated influenza vaccine (LAIV) not be used as a seasonal flu vaccine. Volunteers were patients undergoing tonsillectomy for treatment of obstructive sleep apnea (OSA).
In the initial pilot phase of the study, up to 3 volunteers will be enrolled and will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4) given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy. Enrollment of the remaining study volunteers into the main portion of the study will begin once the initial pilot phase is completed. All of the remaining study volunteers will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4) intranasally.
The second study visit for all volunteers will occur at the time of the volunteer's tonsillectomy surgery, 3-14 days after Visit 01. A member of the surgical team will collect a 20 mL blood sample and a sample of the resected tonsil tissue that would otherwise be discarded to be distributed to the lab.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot phase | Other | 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. |
|
| Study phase | Other | Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone® | Biological | quadrivalent, inactivated influenza virus vaccine, intramuscular |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received Influenza Vaccine | Day 0 | |
| Number of Participants With Related Adverse Events | Day 0 to 14 post-immunization |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cornelia Dekker, MD | Stanford University | Principal Investigator |
| Mark Davis, PhD | Stanford University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Phase (IIV4) | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Received Influenza Vaccine | Study halted after Pilot Phase | Posted | Count of Participants | Participants | Day 0 |
|
14 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Phase (IIV4) | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cornelia Dekker | Stanford University School of Medicine, Dept. of Pediatrics | 650-724-4437 | cdekker@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C000613429 | FluMist |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
3-5 participants will receive quadrivalent inactivated flu (IIV4) vaccine as a pilot study to establish protocols for immune cell isolation. Once the pilot study ends, all new participants will receive live, attenuated influenza vaccine and IIV4 will no longer be utilitzed.
Not provided
Not provided
Not provided
Not provided
| FluMist® |
| Biological |
quadrivalent, live, attenuated influenza vaccine, intranasal spray |
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of Participants With Related Adverse Events | Posted | Count of Participants | Participants | Day 0 to 14 post-immunization |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Study Phase (LAIV4) | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |