Influenza VaccinationPhase 4NCT03346772
Study of Immune Responses to Influenza Vaccination
A Phase 4 study testing Influenza vaccination in people with Influenza Vaccination, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccination
- What is being tested?
- Influenza vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling adults able to provide consent who need influenza vaccination for standard of care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Influenza Vaccination
- Being tested
- Influenza vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccinationBiological
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination cohort | Experimental | Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care. Receives: Biological: Influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza neutralizing antibody titers
Measured: 21-42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start20 Oct 2017
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccinationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E.John Wherry, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346772
- Sponsor's protocol ID
- 820590
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2017
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Immune Responses to Influenza Vaccination
- ClinicalTrials.gov ID
- NCT03346772
- Acronym / sponsor ID
- 820590
- Conditions
- Influenza Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination cohort | Experimental | Biological: Influenza vaccinationAdults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community-dwelling adults able to provide consent who need influenza vaccination for standard of care
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccinationAdults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care. | Biological | Influenza vaccination cohort |
Primary outcome
Influenza neutralizing antibody titers
Time frame: 21-42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E.John Wherry, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza vaccination in people with Influenza Vaccination, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza neutralizing antibody titers (time frame: 21-42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.