NCT03346772

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
2mo left

Started Oct 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Oct 2017Jul 2026

Study Start

First participant enrolled

October 20, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

8.7 years

First QC Date

November 14, 2017

Last Update Submit

August 13, 2025

Conditions

Influenza Vaccination

Outcome Measures

Primary Outcomes (1)

  • Influenza neutralizing antibody titers

    21-42 days

Study Arms (1)

Influenza vaccination cohort

EXPERIMENTAL

Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.

Biological: Influenza vaccination

Interventions

Influenza vaccinationBIOLOGICAL

Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.

Influenza vaccination cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Community-dwelling adults able to provide consent who need influenza vaccination for standard of care

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • E.John Wherry, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sokratis Apostolidis, MD

CONTACT

267-584-6653sokratis.apostolidis@pennmedicine.upenn.edu

E.John Wherry, PhD

CONTACT

wherry@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

October 20, 2017

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)