NCT03884296

Brief Summary

This is one project of a larger ongoing study related to the immune system's response to the flu virus. This study is designed to investigate the immune response to a nasal flu immunization in tonsillar tissue compared to what can be measured in the blood.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

4.6 years

First QC Date

March 19, 2019

Last Update Submit

November 17, 2023

Conditions

Influenza

Keywords

Obstructive sleep apneaQuadrivalent live, attenuated influenza vaccineFlumist

Outcome Measures

Primary Outcomes (2)

  • Plasma HAI titer

    HAI titer measures imune response to influenza vaccination

    Day 3-14 after receipt of LAIV

  • Number of Participants With Related Adverse Events

    We will capture AEs to LAIV

    Day 0 to 14 post-immunization

Study Arms (1)

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.

Biological: FluMist

Interventions

FluMistBIOLOGICAL

Quadrivalent, live, attenuated influenza vaccine, intranasal spray

Study Phase

Eligibility Criteria

Age2 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • year-old male and female patients undergoing tonsillectomy for obstructive sleep apnea or other non-infectious indication.
  • Willing and able to complete the informed consent process
  • Availability for follow-up for the planned duration of the study

You may not qualify if:

  • Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
  • Life-threatening reactions to previous influenza vaccinations
  • Asthma (contraindication for receipt of LAIV4)
  • Allergy to egg or egg products or to vaccine components including gentamicin, gelatin, arginine or MSG.
  • Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
  • History of immunodeficiency (including HIV infection)
  • Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
  • Hospitalization in the past year for congestive heart failure or emphysema.
  • Chronic Hepatitis B or C.
  • Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (\<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
  • Participants in close contact with anyone who has a severely weakened immune system
  • Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
  • Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
  • History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
  • Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Medical Center, Lane building L134

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Influenza, HumanSleep Apnea, Obstructive

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine (Infectious Diseases)

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

April 15, 2019

Primary Completion

November 17, 2023

Study Completion

November 17, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)