Recruiting

Influenza Vaccination

Sponsor:

University of Pennsylvania

Code:

NCT05108818

Conditions

Influenza, Human

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Seasonal influenza vaccine

Study Details

Brief summary:

Cellular and humoral immune responses before and after seasonal influenza vaccination will be assessed. Each year, up to 100 participants will be enrolled. To study age-specific differences in immune responses, participants with various years of birth will be enrolled. The investigators hypothesize that humans with different birth years will mount antibody and cellular responses of different specificities following seasonal influenza vaccination.

Conditions

Influenza, Human

Study ID

NCT05108818

Start date

Oct 7, 2021

Status verified date

Feb, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for all study visits
3. Aged 18 years and older
4. In good health based on self-reported medical conditions via an online survey

Exclusion Criteria:

1. Known allergic reactions to components of the study vaccine
2. Known latex allergy
3. History of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines
4. History of GBS within 6 weeks of receipt of a previous influenza vaccine
5. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months
6. Treatment with immunoglobulin or another blood product within the 3 months prior to enrollment in this study
7. Active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy ("active" is defined as having received treatment within the past 5 years)
8. Long-term (greater than 2 weeks) usage of oral or parenteral steroids, or high-dose inhaled steroids
9. Administration of an influenza vaccine within 2 months prior to enrollment
10. Known acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses
11. Participation in a study that involves an experimental agent or having received an experimental agent (other than a COVID-19 vaccine) within 1 month prior to enrollment or expecting to receive another experimental agent during the study period
12. Intends to donate blood during the study period
13. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
14. Pregnancy
15. Known human immunodeficiency virus, hepatitis B, or hepatitis C infection
16. Any condition that the principal investigator believes may interfere with successful completion of the study

Study Design

Enrollment

700 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Influenza vaccination

Adults will receive a seasonal, inactivated, quadrivalent influenza vaccine administered intramuscularly at a dose of 15 ug of HA per component, as approved by the FDA.

Interventions

Seasonal influenza vaccine

The seasonal influenza vaccine is administered intramuscularly at a dose of 15 ug of HA per component, as approved by the FDA.

Primary outcome measure

  • Effect of year of birth on neutralizing antibody titers elicited by influenza vaccination [ Time Frame: 7 years ]

Central Contacts and Locations

Central contacts

Scott Hensley, PhD

215-573-3756hensley@pennmedicine.upenn.edu

Elizabeth Drapeau, PhD

215-573-3756elizabeth.troisi@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Elizabeth Drapeau, PhD

elizabeth.troisi@pennmedicine.upenn.edu

Scott Hensley, PhD

hensley@pennmedicine.upenn.edu

Principal Investigator:

Scott Hensley, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.