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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of year of birth on neutralizing antibody titers elicited by influenza vaccination
Secondary outcome measures
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
Fingolimod
Placebo
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
~210
Find a Location
Who is running the clinical trial?
Stanford UniversityOTHER
2,395 Previous Clinical Trials
17,340,655 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,484,537 Total Patients Enrolled
The Scripps Research InstituteOTHER
30 Previous Clinical Trials
9,882 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:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently open for this trial?
"Affirmative. Clinicaltrials.gov provides evidence that this experiment, which was initially posted on October 7th 2021, is presently recruiting patients. Approximately 700 individuals need to be enrolled at a single research centre."
Answered by AI
How many individuals is this research endeavor following?
"Affirmative. According to clinicaltrials.gov, this research study is presently recruiting volunteers and the trial was initially posted on October 7th 2021. Last updated on November 17th 2022, it aims to enrol 700 individuals at a single medical facility."
Answered by AI
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