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
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
|Contact: Philip Grantfirstname.lastname@example.org|