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
Disqualifiers: Febrile illness, Active malignancy, others
No Placebo Group
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?
Better understanding of the immune responses to influenza vaccination is needed in order to understand situations of poor vaccine response. Adults will receive influenza vaccination and then have peripheral blood drawn at pre-defined intervals in order to study the lymphocyte responses.
Will I have to stop taking my current medications?
The trial excludes people using immunosuppressing medications, so if you are on these, you would need to stop taking them to participate.
Is the influenza vaccine generally safe for humans?
The influenza vaccine, including various forms like Fluzone Quadrivalent and Afluria Quadrivalent, has been studied for safety in different groups, including pregnant women, older adults, and children. Most reported side effects are mild, such as injection site reactions, fever, and headache, with serious events being rare. Overall, the vaccine is considered safe based on these studies.12345
How is the influenza vaccine treatment different from other flu treatments?
The influenza vaccine is unique because it includes a quadrivalent formulation, which means it protects against four different strains of the flu virus, including two influenza A subtypes and two B types. This broader protection helps reduce the risk of the vaccine not matching the dominant circulating B strain, offering better protection compared to trivalent vaccines that only cover three strains.46789
Eligibility Criteria
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.Inclusion Criteria
I live at home, can make my own decisions, and need a flu shot.
Exclusion Criteria
You have donated blood in the last 60 days.
I have received the flu vaccine in the last 6 months.
I currently have cancer.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine
1 day
1 visit (in-person)
Follow-up
Participants have peripheral blood drawn at pre-defined intervals to study lymphocyte responses
4-8 weeks
Treatment Details
Interventions
- Influenza vaccination (Virus Therapy)
Trial OverviewThe 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.
Participant Groups
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.
Influenza vaccination is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Influenza Vaccination for:
- Prevention of influenza A and B infections in individuals aged 6 months and older
🇺🇸 Approved in United States as Influenza Vaccination for:
- Prevention of influenza A and B infections in individuals aged 6 months and older
🇨🇦 Approved in Canada as Influenza Vaccination for:
- Prevention of influenza A and B infections in individuals aged 6 months and older
🇯🇵 Approved in Japan as Influenza Vaccination for:
- Prevention of influenza A and B infections in individuals aged 6 months and older
🇦🇺 Approved in Australia as Influenza Vaccination for:
- Prevention of influenza A and B infections in individuals aged 6 months and older
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
References
Postmarketing safety surveillance of high-dose quadrivalent influenza vaccine: Reports to the Vaccine Adverse Event Reporting System. [2022]On November 4, 2019, the Food and Drug Administration approved high-dose quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent; QIV-HD) for active immunization for the prevention of influenza disease in individuals 65 years of age and older. A prelicensure randomized, active-controlled, modified double-blind trial did not reveal any major differences in adverse events following QIV-HD versus Fluzone High-Dose (trivalent). To improve our understanding of the safety profile of QIV-HD, we reviewed and summarized reports of adverse events after QIV-HD to the Vaccine Adverse Event Reporting System (VAERS). From July 30, 2020 through June 30, 2021, VAERS received 2,122 reports after QIV-HD. The vast majority (2,018; 95.1%) were non-serious and included events that had been observed in the prelicensure clinical trial, such as injection site reactions, fever, headache, and nausea. The most common serious events included Guillain-Barré syndrome, cellulitis or other local reactions, constitutional signs/symptoms (e.g., fever), and cardiovascular events. Our review did not reveal any new safety concerns. This information may enable policy makers, health officials, clinicians, and patients to make a more informed decision regarding vaccination strategies.
Improved post-marketing safety surveillance of quadrivalent inactivated influenza vaccine in Mexico using a computerized, SMS-based follow-up system. [2022]Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages. Risk-monitoring of QIVs to identify adverse events (AEs) is necessary as influenza vaccines are reformulated each year. We developed a new active surveillance system (Sistema de Control de Vacunación; SICOVA) to improve pharmacovigilance in Mexico. Participants (N = 2013) aged 0 - 96 years from nine sites across three influenza seasons (n = 1166 in 2015 - 2016; n = 633 in 2016 - 2017; and n = 214 in 2017 - 2018) agreed to receive text messages 1, 7, 28, and 42 days post-vaccination to know if they had experienced any AEs. The study was completed electronically by 1763 (87.6%) participants; manual follow-up was conducted for 250 participants whose reporting was incomplete. The overall AE rate was 9.09%. At least one AE was reported by 183 participants, of whom 131 (71.58%) did not require a medical visit and 52 (28.42%) needed medical attention, with none requiring hospitalization. Most AEs requiring medical attention occurred in children aged 0 - 5 years (n = 22, 42.31%) and adults aged 31 - 35 years (n = 5, 9.62%). These results are consistent with the established safety profile of Fluzone® Quadrivalent, and show that SICOVA can facilitate surveillance and increase AE reporting in Mexico.
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.
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.
Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in healthy subjects aged 3 to 17 years old: A phase III, open label, single-arm study. [2021]Quadrivalent influenza vaccines are particularly valuable during seasons in which a mismatch occurs between the predicted influenza B lineage for the trivalent influenza vaccine and the circulating strain. This study evaluated the immunogenicity and safety of a quadrivalent inactivated influenza vaccine AdimFlu-S manufactured in Taiwan for the 2016-2017 influenza season in healthy children.
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.
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.
Safety of Intranasal Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) in Children and Adolescents: A Pilot Prospective Cohort Study in England. [2018]Fluenz Tetra is an intranasal quadrivalent live attenuated influenza vaccine (QLAIV) and is recommended as the vaccine of choice for children in the 2014/2015 influenza season vaccination programme in the UK.
Safety and immunogenicity of revaccination with reduced dose intradermal and standard dose intramuscular influenza vaccines in adults 18-64 years of age. [2013]This clinical trial examined the safety and immunogenicity of annual revaccination with Fluzone(®) Intradermal (Sanofi Pasteur, Swiftwater, PA) vaccine compared to a standard intramuscular (IM) split-virion trivalent influenza vaccine (Fluzone(®), Sanofi Pasteur).