Influenza Vaccine for Flu
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Pennsylvania
Must not be taking: Immunosuppressants, Chemotherapy, Steroids, others
Disqualifiers: Allergies, Immunosuppression, Cancer, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 5 Jurisdictions
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.
12345Is 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.
14678How 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.
13459Eligibility 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
+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.
+13 more
Trial 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
Participant Groups
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.
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
🇪🇺 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
Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
Stanford UniversityCollaborator
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
The Scripps Research InstituteCollaborator
References
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. [2019]In the Southern Hemisphere 2010 influenza season, Seqirus' split-virion, trivalent inactivated influenza vaccine was associated with increased reports of fevers and febrile reactions in young children. A staged clinical development program of a quadrivalent vaccine (Seqirus IIV4 [S-IIV4]; Afluria® Quadrivalent/Afluria Quad™/Afluria Tetra™), wherein each vaccine strain is split using a higher detergent concentration to reduce lipid content (considered the cause of the increased fevers and febrile reactions), is now complete.
Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2019-20 Influenza Season. [2020]This report updates the 2018-19 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2018;67[No. RR-3]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. A licensed, recommended, and age-appropriate vaccine should be used. Inactivated influenza vaccines (IIVs), recombinant influenza vaccine (RIV), and live attenuated influenza vaccine (LAIV) are expected to be available for the 2019-20 season. Standard-dose, unadjuvanted, inactivated influenza vaccines will be available in quadrivalent formulations (IIV4s). High-dose (HD-IIV3) and adjuvanted (aIIV3) inactivated influenza vaccines will be available in trivalent formulations. Recombinant (RIV4) and live attenuated influenza vaccine (LAIV4) will be available in quadrivalent formulations.Updates to the recommendations described in this report reflect discussions during public meetings of ACIP held on October 25, 2018; February 27, 2019; and June 27, 2019. Primary updates in this report include the following two items. First, 2019-20 U.S. trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/Brisbane/02/2018 (H1N1)pdm09-like virus, an A/Kansas/14/2017 (H3N2)-like virus, and a B/Colorado/06/2017-like virus (Victoria lineage). Quadrivalent influenza vaccines will contain HA derived from these three viruses, and a B/Phuket/3073/2013-like virus (Yamagata lineage). Second, recent labeling changes for two IIV4s, Afluria Quadrivalent and Fluzone Quadrivalent, are discussed. The age indication for Afluria Quadrivalent has been expanded from ≥5 years to ≥6 months. The dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for all persons aged ≥36 months (≥3 years). The dose volume for Fluzone Quadrivalent for children aged 6 through 35 months, which was previously 0.25 mL, is now either 0.25 mL or 0.5 mL. The dose volume for Fluzone Quadrivalent is 0.5 mL for all persons aged ≥36 months (≥3 years).This report focuses on the recommendations for use of vaccines for the prevention and control of influenza during the 2019-20 season in the United States. A brief summary of these recommendations and a Background Document containing additional information are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to U.S.-licensed influenza vaccines used within Food and Drug Administration-licensed indications. Updates and other information are available from CDC's influenza website (https://www.cdc.gov/flu). Vaccination and health care providers should check this site periodically for additional information.
Quadrivalent inactivated influenza vaccine (VaxigripTetra™). [2018]VaxigripTetra™ (IIV4; Sanofi Pasteur) is a quadrivalent split-virion influenza vaccine approved in Europe in 2016 for individuals ≥ 3 years of age. IIV4 builds on the well-established record of the trivalent split-virion influenza vaccine (Vaxigrip®). Areas covered: This literature review summarizes the rationale for developing quadrivalent influenza vaccines and discusses the phase III clinical trial results supporting the immunogenicity, safety, and tolerability of IIV4. Expert commentary: IIV4 is immunogenic and well tolerated. Adding a second B strain to the trivalent split-virion influenza vaccine provides a superior immune response for the additional strain but does not reduce the immune response for the three other strains or negatively affect the safety profile. By offering broader protection against co-circulating influenza B lineages, IIV4 has the potential to further reduce influenza-related morbidity and mortality beyond that achieved with trivalent vaccines.
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]Vaxigrip, a trivalent split-virion, inactivated vaccine available since 1968 has been in use longer than any other influenza vaccine. It is the most widely-used influenza vaccine, with more than 1.8 billion doses distributed in more than 120 countries. Areas covered: The significant body of evidence that confirms the efficacy, effectiveness, immunogenicity, and safety of Vaxigrip in healthy individuals of all ages and at-risk populations is summarized. The results from at least 15 randomized efficacy trials and 15 other studies have demonstrated that vaccination with Vaxigrip is efficacious against various clinical endpoints. It was estimated that more than 37 million laboratory-confirmed influenza episodes, 476,000 influenza-related hospitalizations, and 67,000 influenza-related deaths have been avoided by the more than 1.8 billion doses of Vaxigrip that have been distributed, emphasizing its important public health impact. Expert commentary: This strong evidence base in favor of Vaxigrip provides a robust foundation to support the implementation of the quadrivalent formulation. This quadrivalent formulation of Vaxigrip contains two A and two B influenza strains (VaxigripTetra), and has a similar immunogenicity and safety profile to the trivalent formulation while offering broader protection due to the addition of the second influenza B strain.
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]The inactivated quadrivalent split-virus seasonal influenza vaccine [Fluarix® quadrivalent, manufactured in Dresden (D-QIV)] contains 15 μg haemagglutinin from each of the four influenza virus strains expected to circulate in the upcoming influenza season. Unlike seasonal trivalent influenza vaccines (TIVs), which have been used previously, quadrivalent influenza vaccines (QIVs) contain two influenza A subtype viruses and two B type viruses. As two different B viruses have co-circulated in recent years, incorporating both B lineages reduces the risk of the dominant B strain not being included in the vaccine. D-QIV is approved for active immunization of individuals aged ≥3 years to prevent disease caused by the influenza A subtype viruses and B type viruses contained in the vaccine. In large randomized, controlled trials, D-QIV was highly immunogenic in healthy adults (including individuals aged ≥65 years) and children, and exceeded the criteria for vaccine licensure. Immune responses for D-QIV, compared with those for TIVs, were non-inferior against influenza A strains and common B strains and superior against the additional B strain. D-QIV was generally well tolerated in all age groups studied and, overall, reactogenicity and tolerability were generally similar to observations with TIVs. Quadrivalent influenza vaccines are expected to offer substantial cost-effectiveness benefits in seasons where the B lineage selected for inclusion in TIVs does not match the dominant circulating strain. Thus, by incorporating both circulating influenza B lineages, vaccination with D-QIV is likely to reduce the risk of the dominant circulating B type virus not matching the strain selected for the vaccine and, therefore, more effectively protect target populations from influenza than TIVs.
Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. [2022]The Fluzone® Quadrivalent (IIV4, Sanofi Pasteur) Pregnancy Registry was created to monitor vaccine safety during pregnancy (clinicaltrials.gov, NCT01945424). Here, we describe maternal, pregnancy, obstetrical and neonatal outcomes after vaccine exposure in pregnant women between August 2013 and September 2019.
Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season. [2020]Safety surveillance is required for each season's influenza vaccines to rapidly detect and evaluate potential new safety concerns before the peak period of immunization. Here we report the results of an enhanced passive safety surveillance for a trivalent split-virion inactivated influenza vaccine (IIV3; Vaxigrip®), an intradermal version of this vaccine (IIV3-ID; Intanza® 15 µg), and a recently licensed quadrivalent version (IIV4; VaxigripTetraTM) during the 2017/18 influenza season in the UK and Republic of Ireland. The primary objective was to determine the rates of adverse reactions (ARs) occurring within 7 days following routine vaccination. Between September and November 2017, 979 safety report cards were distributed to vaccinees receiving IIV3-ID, 1005 to those receiving IIV3, and 957 to those receiving IIV4. At least one AR was reported by 28 participants (2.9%) vaccinated with IIV3-ID, 14 participants (1.4%) vaccinated with IIV3, and 20 participants (2.1%) vaccinated with IIV4. The most frequent ARs were injection-site reactions and headache. One participant vaccinated with IIV3-ID reported two suspected serious ARs (dyskinesia and a shock symptom), although these could not be confirmed as vaccine-related. Rates of ARs for IIV3 and IIV3-ID for 2017/18 did not differ from the 2016/17 rates. For IIV4, in its first season since licensure, AR frequencies were similar to those in the Summary of Product Characteristics. In conclusion, no change was found compared to the known or expected AR rates for IIV3, IIV3-ID, or IIV4 during the 2017/18 season.
Safety and immunogenicity of high doses of quadrivalent influenza vaccine in children 6 months through [2021]Quadrivalent high-dose inactivated influenza vaccine (Fluzone® High-Dose Quadrivalent, IIV4-HD) was licensed in the USA in 2019 for adults ≥ 65 years of age. This Phase II study examined safety and immunogenicity of 3 dose formulations of IIV4-HD in healthy children. In a randomized, modified double-blind, active-controlled trial in the USA and Canada, 661 children aged 6 months through
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]A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.