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Seasonal influenza vaccine for Flu

University of Pennsylvania, Philadelphia, PA
FluSeasonal influenza vaccine - Biological
Eligibility
18+
All Sexes
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Study Summary

This trial will study the immune responses of different age groups before and after they receive the seasonal influenza vaccine.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 7 years

7 years
Assessment of B cell responses to influenza vaccination in individuals of different birth years
Assessment of the circulating T follicular helper cell response 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
Changes in serum HAI antibodies in individuals of different birth years following influenza vaccination
Differences in levels of HA stalk-binding antibodies in individuals of different birth years following influenza vaccination
Differences in levels of NA-binding antibodies in individuals of different birth years following influenza vaccination
Effect of year of birth on neutralizing antibody titers elicited by influenza vaccination

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Influenza Virus Type A H3N2 Challenge
1
Sing2016 M2SR H3N2
1
Influenza Vaccine

Side Effects for

Fingolimod
19%Headache
16%Nasopharyngitis
12%Upper respiratory tract infection
11%Lymphopenia
7%Cough
5%Urinary tract infection
3%Diarrhoea
3%Fatigue
2%Nausea
1%Paraparesis
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT01199861) in the Fingolimod ARM group. Side effects include: Headache with 19%, Nasopharyngitis with 16%, Upper respiratory tract infection with 12%, Lymphopenia with 11%, Cough with 7%.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1 Treatment Group

Influenza vaccination
1 of 1

Experimental Treatment

700 Total Participants · 1 Treatment Group

Primary Treatment: Seasonal influenza vaccine · No Placebo Group · Phase 4

Influenza vaccination
Biological
Experimental Group · 1 Intervention: Seasonal influenza vaccine · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seasonal influenza vaccine
2010
Completed Phase 3
~140

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 years

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,183 Previous Clinical Trials
4,980,198 Total Patients Enrolled
Stanford UniversityOTHER
2,220 Previous Clinical Trials
34,901,904 Total Patients Enrolled
The Scripps Research InstituteOTHER
30 Previous Clinical Trials
9,882 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
1,896 Previous Clinical Trials
41,212,223 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

Has the FDA endorsed Seasonal influenza vaccine?

"As this is a Phase 4 trial and Seasonal influenza vaccine has already been approved, the treatment's safety rating was established as a 3." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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