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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:

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I have been using steroids for more than 2 weeks.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

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 more

Side effects data

From 2011 Phase 3 trial • 138 Patients • NCT01199861

19%

Headache

16%

Nasopharyngitis

12%

Upper respiratory tract infection

11%

Lymphopenia

Cough

Urinary tract infection

Fatigue

Diarrhoea

Nausea

Paraparesis

100%

80%

60%

40%

20%

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

0 / 2Eligibility criteria met