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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):

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.

Condition or disease Intervention/treatment Phase
Influenza Vaccination Biological: Influenza vaccination Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of Immune Responses to Influenza Vaccination
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Influenza vaccination cohort
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Biological: Influenza vaccination
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.


Outcome Measures

Primary Outcome Measures :
  1. Influenza neutralizing antibody titers [ Time Frame: 21-42 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

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): NCT03346772


Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ramin Herati, MD    417-827-9031    ramin.herati@uphs.upenn.edu   
Principal Investigator: E. John Wherry, PhD         
Sponsors and Collaborators
University of Pennsylvania
More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03346772     History of Changes
Other Study ID Numbers: 820590
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs