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Study of Immune Responses to Influenza Vaccination

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ClinicalTrials.gov Identifier: NCT03346772
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

November 14, 2017
November 17, 2017
November 17, 2017
October 20, 2017
July 1, 2020   (Final data collection date for primary outcome measure)
Influenza neutralizing antibody titers [ Time Frame: 21-42 days ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Immune Responses to Influenza Vaccination
Study of Immune Responses to Influenza Vaccination
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Influenza Vaccination
Biological: Influenza vaccination
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Experimental: Influenza vaccination cohort
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Intervention: Biological: Influenza vaccination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Same as current
July 1, 2020
July 1, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
United States
 
 
NCT03346772
820590
No
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
Plan to Share IPD: No
University of Pennsylvania
University of Pennsylvania
Not Provided
Not Provided
University of Pennsylvania
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP