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Virus Therapy
Influenza Vaccine for Flu
Phase 4
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Long-term (greater than 2 weeks) usage of oral or parenteral steroids, or high-dose inhaled steroids
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
Summary
This trial will study the immune responses of different age groups before and after they receive the seasonal influenza vaccine.
Who is the study for?
Healthy adults aged 18 and older who are willing to follow the study procedures can join. They must not have had a flu shot in the last 2 months, any blood products or immunosuppressive treatments in the past 3 months, or cancer treatments within the last 3 years. People with certain allergies, immune conditions, or those on long-term steroids cannot participate.
What is being tested?
The trial is studying how different age groups respond to the seasonal influenza vaccine by looking at their antibody and cellular responses. Up to 100 participants will be enrolled each year to see if birth year affects immunity after vaccination.
What are the potential side effects?
While specific side effects aren't listed for this trial, common reactions to flu vaccines include soreness at injection site, mild fever, fatigue, headache and muscle aches.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been using steroids for more than 2 weeks.
Select...
I have not taken any experimental drugs in the last month, except for a COVID-19 vaccine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effect of year of birth on neutralizing antibody titers elicited by influenza vaccination
Secondary study objectives
Assessment of B cell responses to influenza vaccination in individuals of different birth years
Assessment of the frequency of circulating T follicular helper cell response to influenza vaccination in individuals of different birth years
Assessment of the functionality of circulating T follicular helper cell response to influenza vaccination in individuals of different birth years
+3 moreSide effects data
From 2011 Phase 3 trial • 138 Patients • NCT0119986119%
Headache
16%
Nasopharyngitis
12%
Upper respiratory tract infection
11%
Lymphopenia
7%
Cough
5%
Urinary tract infection
3%
Fatigue
3%
Diarrhoea
2%
Nausea
1%
Paraparesis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fingolimod
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Influenza vaccinationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seasonal influenza vaccine
2010
Completed Phase 3
~10210
Find a Location
Who is running the clinical trial?
Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,518,512 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,336 Previous Clinical Trials
5,382,134 Total Patients Enrolled
The Scripps Research InstituteOTHER
32 Previous Clinical Trials
9,858 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,348 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received a flu shot within the last 2 months.I don't have any health conditions that would make vaccination unsafe for me.I am 18 years old or older.I have not used immunosuppressive drugs or undergone chemotherapy or radiation in the last 3 years.I have not received immunoglobulin or blood products in the last 3 months.I have not been treated for cancer, except skin or stable prostate cancer, in the last 5 years.I have been using steroids for more than 2 weeks.I have not taken any experimental drugs in the last month, except for a COVID-19 vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Influenza vaccination
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.