Back to resultsStudy of Immune Responses to Influenza Vaccination
Primary Purpose
Influenza Vaccination
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Influenza vaccination
Sponsored by
About this trial
This is an interventional basic science trial for Influenza Vaccination
Eligibility Criteria
Inclusion Criteria:
- Community-dwelling adults able to provide consent who need influenza vaccination for standard of care
Exclusion Criteria:
- febrile illness at time of vaccination
- active malignancy
- use of immunosuppressing medications
- blood donation in the past 60 days
- influenza vaccinated during the preceding 6 months
- allergic reactions to influenza vaccination
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Influenza vaccination cohort
Arm Description
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Outcomes
Primary Outcome Measures
Influenza neutralizing antibody titers
Secondary Outcome Measures
Full Information
NCT ID
NCT03346772
First Posted
November 14, 2017
Last Updated
October 17, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03346772
Brief Title
Study of Immune Responses to Influenza Vaccination
Official Title
Study of Immune Responses to Influenza Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Better understanding of the immune responses to influenza vaccination is needed in order to understand situations of poor vaccine response. Adults will receive influenza vaccination and then have peripheral blood drawn at pre-defined intervals in order to study the lymphocyte responses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccination
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Influenza vaccination cohort
Arm Type
Experimental
Arm Description
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Intervention Type
Biological
Intervention Name(s)
Influenza vaccination
Intervention Description
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Primary Outcome Measure Information:
Title
Influenza neutralizing antibody titers
Time Frame
21-42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Community-dwelling adults able to provide consent who need influenza vaccination for standard of care
Exclusion Criteria:
febrile illness at time of vaccination
active malignancy
use of immunosuppressing medications
blood donation in the past 60 days
influenza vaccinated during the preceding 6 months
allergic reactions to influenza vaccination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sokratis Apostolidis, MD
Phone
267-584-6653
Email
sokratis.apostolidis@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
E.John Wherry, PhD
Email
wherry@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E.John Wherry, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sokratis Apostolidis, MD
Phone
267-584-6653
Email
sokratis.apostolidis@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
E. John Wherry, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Immune Responses to Influenza Vaccination
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