Influenza Vaccine for Flu
Recruiting in Palo Alto (17 mi)
Overseen byEdmund K Waller, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Emory University
Disqualifiers: Pregnancy, Nursing, Prisoners, Cognitively impaired, others
No Placebo Group
Prior Safety Data
Approved in 10 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness.
This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults.
Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study doctor to get a clear answer.
Is the influenza vaccine safe for humans?
Research shows that various influenza vaccines, including Flublok, Vaxigrip, Intanza, and Fluarix Tetra, are generally safe for humans. Studies have reported some mild adverse reactions, but these are consistent with known safety profiles and do not indicate any major safety concerns.
12345How is the influenza vaccine different from other flu treatments?
The influenza vaccine is unique because it is a preventive measure that helps the body build immunity against the flu virus, unlike other treatments that are used to manage symptoms after infection. It is administered as an injection or nasal spray, and it contains inactivated or weakened virus components to stimulate the immune system without causing illness.
678910Eligibility Criteria
This trial is for healthy adults who can consent to participate, from any gender, race, or ethnic group. It's not for those vulnerable to coercion (like minors or cognitively impaired), pregnant/nursing women, prisoners, or anyone unable to consent.Inclusion Criteria
I am a healthy adult.
I belong to any gender, race, or ethnic group.
I can make my own medical decisions.
Exclusion Criteria
I am an adult capable of making my own decisions and not easily influenced.
Women who are pregnant or nursing a child may not take part in this study. If a woman of childbearing potential is enrolled in this study, she and the study doctor must agree on a method of birth control to use throughout the study. Enrollees who think that they may have gotten pregnant during the study must tell the study doctor immediately. Pregnant women will be taken out of the study.
Prisoners
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Vaccination
Participants receive a single dose of the FDA-approved influenza vaccine
1 day
1 visit (in-person)
Monitoring
Participants undergo serial blood and bone marrow sampling to assess immune response
1 year
Multiple visits on days 0, 7, 28, 90, and 365
Follow-up
Participants are monitored for safety and effectiveness after vaccination
4 weeks
Participant Groups
The study tests the immune response to a killed flu vaccine in healthy people. It's an open label and single arm observational study where participants get the flu shot and provide blood and bone marrow samples over a year.
1Treatment groups
Experimental Treatment
Group I: Influenza VaccineExperimental Treatment1 Intervention
Healthy male and female individuals aged 18-64 years will be eligible to participate in this study.
Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers
Influenza Vaccine is already approved in United States, European Union, United States, European Union, United States, European Union, United States, European Union, European Union, European Union for the following indications:
🇺🇸 Approved in United States as Afluria for:
- Prevention of influenza A and B
🇪🇺 Approved in European Union as Fluarix for:
- Prevention of influenza A and B
🇺🇸 Approved in United States as Flucelvax for:
- Prevention of influenza A and B
🇪🇺 Approved in European Union as Flulaval for:
- Prevention of influenza A and B
🇺🇸 Approved in United States as Fluzone for:
- Prevention of influenza A and B
🇪🇺 Approved in European Union as Fluad for:
- Prevention of influenza A and B in adults 65 years and older
🇺🇸 Approved in United States as FluMist for:
- Prevention of influenza A and B in individuals 2-49 years old
🇪🇺 Approved in European Union as Influvac for:
- Prevention of influenza A and B
🇪🇺 Approved in European Union as Optaflu for:
- Prevention of influenza A and B
🇪🇺 Approved in European Union as Vaxigrip for:
- Prevention of influenza A and B
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory University HospitalAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
Enhanced passive surveillance of influenza vaccination in England, 2016-2017- an observational study using an adverse events reporting card. [2020]Influenza is a major public health burden, mainly prevented by vaccination. Recommendations on influenza vaccine composition are updated annually and constant benefit-risk monitoring is therefore needed. We conducted near-real-time enhanced passive surveillance (EPS) for the influenza vaccine, Fluarix Tetra, according to European Medicines Agency guidance, in 10 volunteer general practices in England using Fluarix Tetra as their principal influenza vaccine brand, from 1-Sep to 30-Nov-2016. The EPS method used a combination of routinely collected data from electronic health records (EHR) and a customized adverse events reporting card (AERC) distributed to participants vaccinated with Fluarix Tetra. For participants vaccinated with a different influenza vaccine, data were derived exclusively from the EHR. We reported weekly and cumulative incidence of pre-defined adverse events of interest (AEI) occurring within 7 days post-vaccination, adjusted for clustering effect. Of the 97,754 eligible participants, 19,334 (19.8%) received influenza vaccination, of whom 13,861 (71.7%) received Fluarix Tetra. A total of 1,049 participants receiving Fluarix Tetra reported AEIs; 703 (67%) used the AERC (adjusted cumulative incidence rate 4.96% [95% CI: 3.92-6.25]). Analysis by individual pre-specified AEI categories identified no safety signal for Fluarix Tetra. A total of 62 individuals reported an AEI with a known brand of non-GSK influenza vaccine and 54 with an unknown brand (adjusted cumulative incidence rate 2.59% [1.93-3.47] and 1.77% [1.42-2.20], respectively). In conclusion, the study identified no safety signal for Fluarix Tetra and showed that the AERC was a useful tool that complemented routine pharmacovigilance by allowing more comprehensive capture of AEIs.
Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season. [2021]In compliance with the European Medicine Agency guidance to detect any potential safety concerns associated with influenza vaccination, an enhanced safety surveillance study was conducted in England during the 2017/18 influenza season. The primary objective was to estimate the incidence rates of adverse events occurring within seven days of vaccination with Fluarix Tetra. In nine General Practices, seasonal influenza vaccine was administered to patients according to local guidelines. Events following immunization were collected using customized cards (enhanced component) combined with electronic health records [EHRs] (EHR component) to estimate incidence rates of adverse events experienced post vaccination. The study ran from 01-Sep-2017 to 30-Nov-2017. A total of 23,939 subjects were vaccinated of whom 16,433 received Fluarix Tetra. The cumulative incidence rates of adverse events of interest for Fluarix Tetra were 7.25% [95% CI, 5.95-8.73] for events reported by card alone, and 9.21% [95% CI, 7.37-11.34] when combined with EHR data. The type and frequency of events reported were consistent with the Fluarix Tetra Summary of Product Characteristics. The study supports and confirms the safety profile of Fluarix Tetra. ClinicalTrials.gov number: NCT03278067.
Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season. [2019]Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15 µg. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15 µg (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15 µg only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.
Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16. [2018]Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 µg to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season. Among the Vaxigrip vaccinees (n = 1,012), 32 (3.2%) reported a total of 122 suspected ARs, including 110 suspected ARs that occurred within 7 days post vaccination. Among the Intanza 15 µg vaccinees (n = 1,017), 31 (3.0%) reported a total of 114 suspected ARs, including 99 that occurred within 7 days post-vaccination. These results were consistent with the known safety profile of the two vaccines and did not show any change in reactogenicity or safety concerns. This passive ESS showed improved data reporting and demonstrated its suitability to health authorities' requirements; further fine tuning of the methodology is under discussion between all stakeholders.
Randomized comparison of the safety of Flublok(®) versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥ 50 years of age. [2022]The safety and tolerability of Flublok(®), a purified recombinant hemagglutinin seasonal influenza vaccine, was compared to AFLURIA(®) in a randomized, blinded clinical trial in adults ≥ 50 years of age with attention to hypersensitivity reactions.
Intravitreal Fluocinolone Acetonide Implant (ILUVIEN®) for the Treatment of Retinal Conditions. A Review of Clinical Studies. [2023]Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) is a corticosteroid implant indicated for the treatment of diabetic macular oedema (DMO) in patients who have previously received conventional treatment without good response, non-infectious posterior uveitis, and as an off-label treatment of the macular oedema secondary to retinal vein occlusion. FAc is a non-biodegradable 0.19 mg intravitreal implant which is designed to release FAc over 3 years at a rate of approximately 0.2 mcg per day. The aim of this review is to describe the special pharmacological properties of Iluvien and display the outcomes of the most important clinical trials and real-world studies regarding its efficacy and safety for the management of the above retinal disorders.
Optical Coherence Tomography Biomarkers: Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19-mg Fluocinolone Acetonide Implant. [2022]The 0.19-mg fluocinolone acetonide (FAc) implant (ILUVIEN®; Alimera Sciences Ltd., Hampshire, UK) was approved for the treatment of vision impairment associated with chronic and refractory diabetic macular edema (DME).
Evaluating the Safety, Efficacy and Patient Acceptability of Intravitreal Fluocinolone Acetonide (0.2mcg/Day) Implant in the Treatment of Non-Infectious Uveitis Affecting the Posterior Segment. [2021]Long-acting, slow-release injectable fluocinolone intravitreal implants have been approved for the treatment of non-infectious uveitis affecting the posterior segment. We summarise the development of intravitreal fluocinolone implants and discuss the technology including pharmacokinetics. We conducted a systematic review of evidence for the efficacy, safety and patient acceptability of fluocinolone 0.18 mg and 0.19 mg injectable implants. We summarise evidence from the pivotal phase 3 studies that lead to the approval of these implants and evaluate real-world including disease-specific evidence. Safety including injection-related events and long-term adverse events is presented.
Use of flucinolone acetonide for patients with diabetic macular oedema: patient selection criteria and early outcomes in real world setting. [2018]Fluocinolone acetonide slow release implant (Iluvien®) was approved in December 2013 in UK for treatment of eyes which are pseudophakic with DMO that is unresponsive to other available therapies. This approval was based on evidence from FAME trials which were conducted at a time when ranibizumab was not available. There is a paucity of data on implementation of guidance on selecting patients for this treatment modality and also on the real world outcome of fluocinolone therapy especially in those patients that have been unresponsive to ranibizumab therapy.
Contribution of the rapid viral diagnosis by immunofluorescence to the choice of therapy in uveitis cases. [2013]Viral and inframicrobial antigens were detected by immunofluorescence (IF) in exfoliated conjunctival and corneal cells from 22 patients with uveitis, 2-9 different antigens being simultaneously visualized in 17 of the cases. The treatment applied on the ground of the etiological diagnosis specified by IF reactions consisted in the administration of tetracycline, Flumidin (Virustat), standard gamma-globulin or specific antiherpes immunoglobulin, the NIVGRIP inactivated influenza vaccine. This therapy led to persistent recovery (coincident with the disappearance of the antigens from conjunctival cells) in 15 cases and to clinical improvement in 7 cases. The importance of the rapid viral diagnosis by IF for the choice of an adequate therapy of uveitis is discussed.