Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood (FLU-LN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03898973|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2019
Last Update Posted : March 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Quadrivalent inactivated influenza vaccine (IIV)||Phase 4|
This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age.
Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection.
The study has a total of 3 visits.
Screening Visit: Procedures during this visit are: Informed consent process, assess eligibility collect relevant clinical data and obtain 10 mL of blood to ensure the FNA will be safe (acceptable CBC and PT/PTT).
Visit 1: Vaccination Visit:
Eligible subjects will return and have a 20 mL blood sample. Participants will receive the inactivated flu vaccine into the right anterior quadriceps. Volunteers will be monitored for at least 15 minutes after study vaccination.
Visit 2: FNA Procedure: Seven days after vaccination the participant will return for another collection of 20 ml of blood and a fine needle aspiration of a right inguinal lymph node under ultrasound guidance by a trained pathologist.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood|
|Actual Study Start Date :||April 11, 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Participants will be given the current year's a quadrivalent inactivated influenza vaccine (IIV)
Biological: Quadrivalent inactivated influenza vaccine (IIV)
Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.
Other Name: Fluzone Quadrivalent
- HAI titer [ Time Frame: Day 7 after vaccination ]This measures response to influenza vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898973
|United States, California|
|Stanford University Medical Center, Lane building L134|
|Stanford, California, United States, 94305|