700 Participants Needed

Influenza Vaccine for Flu

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Overseen ByScott Hensley, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Cellular and humoral immune responses before and after seasonal influenza vaccination will be assessed. Each year, up to 100 participants will be enrolled. To study age-specific differences in immune responses, participants with various years of birth will be enrolled. The investigators hypothesize that humans with different birth years will mount antibody and cellular responses of different specificities following seasonal influenza vaccination.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs, steroids, or have received certain treatments recently, you may not be eligible to participate.

What data supports the effectiveness of the influenza vaccine treatment?

Research shows that quadrivalent influenza vaccines, like VaxigripTetra and Fluarix Quadrivalent, provide broader protection against the flu by including two A and two B virus strains. These vaccines have been shown to be safe and effective in preventing influenza, offering better protection than older trivalent vaccines by covering more virus strains.12345

Is the influenza vaccine generally safe for humans?

The influenza vaccines, including various formulations like Fluzone Quadrivalent and Vaxigrip, have been widely used and studied for safety. They are generally considered safe, with common mild side effects such as injection-site reactions and headaches. Serious adverse reactions are rare, and extensive safety monitoring has shown no unexpected safety concerns.14678

How is the influenza vaccine treatment different from other flu treatments?

The quadrivalent influenza vaccines (QIVs) are unique because they include two influenza A subtypes and two B type viruses, offering broader protection compared to trivalent vaccines (TIVs) that only cover one B strain. This reduces the risk of the vaccine not matching the dominant circulating B strain, providing more effective protection against the flu.13459

Eligibility Criteria

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.

Inclusion Criteria

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for all study visits
In good health based on self-reported medical conditions via an online survey
See 1 more

Exclusion Criteria

Known latex allergy
I received a flu shot within the last 2 months.
I don't have any health conditions that would make vaccination unsafe for me.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a seasonal, inactivated, quadrivalent influenza vaccine administered intramuscularly

1 day
1 visit (in-person)

Follow-up

Participants are monitored for immune responses, including cellular and humoral responses, over several years

7 years

Treatment Details

Interventions

  • Seasonal influenza vaccine
Trial OverviewThe 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.
Participant Groups
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.

Seasonal influenza vaccine is already approved in United States, European Union, Canada, Japan, Switzerland for the following indications:

🇺🇸
Approved in United States as Seasonal influenza vaccine for:
  • Prevention of influenza A and B virus infection
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Approved in European Union as Seasonal influenza vaccine for:
  • Prevention of influenza A and B virus infection
🇨🇦
Approved in Canada as Seasonal influenza vaccine for:
  • Prevention of influenza A and B virus infection
🇯🇵
Approved in Japan as Seasonal influenza vaccine for:
  • Prevention of influenza A and B virus infection
🇨🇭
Approved in Switzerland as Seasonal influenza vaccine for:
  • Prevention of influenza A and B virus infection

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Stanford University

Collaborator

Trials
2,527
Recruited
17,430,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

The Scripps Research Institute

Collaborator

Trials
34
Recruited
12,400+

Findings from Research

The quadrivalent influenza vaccine S-IIV4 demonstrated noninferior immunogenicity compared to the US-licensed C-IIV4 in a study involving 2,247 children aged 6-59 months, indicating it effectively stimulates the immune response against influenza strains.
S-IIV4 was associated with lower rates of fever (5.8%) compared to C-IIV4 (8.4%), suggesting improved safety in terms of febrile reactions, with no reports of febrile convulsions in either vaccine group.
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study.Statler, VA., Albano, FR., Airey, J., et al.[2019]
The 2019-20 seasonal influenza vaccines in the U.S. will include updated strains, specifically targeting A/Brisbane/02/2018 (H1N1), A/Kansas/14/2017 (H3N2), and B/Colorado/06/2017 (Victoria lineage), ensuring better protection against circulating viruses.
Routine annual vaccination is recommended for everyone aged 6 months and older, with specific updates on dosage volumes for certain vaccines, such as Afluria and Fluzone Quadrivalent, to enhance safety and efficacy in different age groups.
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season.Grohskopf, LA., Alyanak, E., Broder, KR., et al.[2020]
VaxigripTetra™ (IIV4) is a quadrivalent influenza vaccine that has been shown to be immunogenic and well tolerated in individuals aged 3 years and older, based on phase III clinical trial results.
The addition of a second B strain in IIV4 enhances the immune response without compromising the response to the other three strains or affecting safety, potentially leading to greater protection against influenza-related illnesses compared to trivalent vaccines.
Quadrivalent inactivated influenza vaccine (VaxigripTetra™).Gresset-Bourgeois, V., Leventhal, PS., Pepin, S., et al.[2018]

References

Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. [2019]
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season. [2020]
Quadrivalent inactivated influenza vaccine (VaxigripTetra™). [2018]
A trivalent, inactivated influenza vaccine (Vaxigrip®): summary of almost 50 years of experience and more than 1.8 billion doses distributed in over 120 countries. [2018]
Inactivated quadrivalent split-virus seasonal influenza vaccine (Fluarix® quadrivalent): a review of its use in the prevention of disease caused by influenza A and B. [2022]
Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. [2022]
Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season. [2020]
Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through [2021]
Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres. [2020]