Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood (IIV-LN)
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|ClinicalTrials.gov Identifier: NCT03898973|
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
|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|
|Estimated Study Start Date :||June 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898973
|Contact: Philip Grantfirstname.lastname@example.org|