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Virus Therapy
Influenza Vaccine for Flu
Phase 4
Recruiting
Led By E.John Wherry, PhD
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 21-42 days
Awards & highlights
Study Summary
This trial will help researchers understand why some people don't respond well to the flu vaccine, so that they can eventually find a way to improve the vaccine.
Who is the study for?
This trial is for adults who can consent and need a flu shot as part of their regular health care. It's not for those with a fever, cancer, on drugs that suppress the immune system, who've donated blood recently or had a flu shot in the last 6 months, or have allergies to flu vaccines.Check my eligibility
What is being tested?
The study involves giving participants an influenza vaccine and then taking samples of their blood at set times afterwards to analyze how their immune cells respond to the vaccination.See study design
What are the potential side effects?
Common side effects from the influenza vaccine may include soreness at injection site, mild fever, muscle pains, and feeling tired. Severe allergic reactions are rare but possible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21-42 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21-42 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Influenza neutralizing antibody titers
Side effects data
From 2012 Phase 3 trial • 6104 Patients • NCT0134659227%
Injection site pain
25%
Pyrexia
14%
Decreased appetite
14%
Upper respiratory tract infection
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Myalgia
7%
Hypersomnia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Influenza vaccination cohortExperimental Treatment1 Intervention
Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza vaccination
2017
Completed Phase 4
~153210
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,134 Total Patients Enrolled
E.John Wherry, PhDPrincipal InvestigatorUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I live at home, can make my own decisions, and need a flu shot.You have donated blood in the last 60 days.I have received the flu vaccine in the last 6 months.I currently have cancer.I am currently taking medication that suppresses my immune system.I do not have a fever or illness at the time of vaccination.You have had allergic reactions to flu shots in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Influenza vaccination cohort
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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the FDA sanctioned Influenza immunization?
"Influenza vaccination has been granted approval and so it scored a 3 on our team's risk evaluation scale."
Answered by AI
How many individuals have participated in this experiment?
"Affirmative. Research hosted on clinicaltrials.gov affirms that this research, which was initially posted in October 2017, is presently attempting to enroll participants. Approximately 75 patients are required from a single site."
Answered by AI
Are new participants still being invited to join this trial?
"Per the information revealed on clinicaltrials.gov, this trial is actively searching for participants to join in its research. The study was first introduced on October 20th 2017 and underwent a recent amendment as of October 12th 2022."
Answered by AI
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