NCT05108818 Characterization of Humoral and Cellular Immune Responses Elicited by Influenza Vaccination in Healthy Adults
| NCT ID | NCT05108818 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Pennsylvania |
| Condition | Influenza, Human |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2021-10-07 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 700 participants in total. It began in 2021-10-07 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05108818 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Influenza, Human. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05108818 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05108818 currently recruiting?
Yes, NCT05108818 is actively recruiting participants. Contact the research team at hensley@pennmedicine.upenn.edu for enrollment information.
Where is the NCT05108818 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT05108818 clinical trial?
NCT05108818 is sponsored by University of Pennsylvania. The trial plans to enroll 700 participants.