However, in some human studies, antibody titers 1:40 have been associated with protection from influenza illness in up to 50% of subjects. We take your privacy seriously. With protection against four flu strains, Fluzone High-Dose is the only influenza vaccine licensed for use in adults 65 years of age and older to have demonstrated superior efficacy in a randomized controlled trial versus a standard dose influenza vaccine for the prevention of laboratory-confirmed influenza illness and the only influenza . 0.5-mL Dose of Fluzone Quadrivalent in Children 6 Months through 35 Months of Age. Vaccine 2021; 39: A24-A35. an A/Wisconsin/588/2019 (H1N1) pdm09-like virus. Need help with SupplyManager? Storage Requirements. Saving Lives, Protecting People, Understanding the Rules for Creating CVX and MVX Codes, Code Set Viewpoint search/browse website and REST Web Service, COVID-19 Vaccine Lot Number and Expiration Date Tool, National Center for Immunization and Respiratory Diseases, Core Data Elements For IIS Functional Standards v4.0, Clinical Decision Support for Immunization (CDSi), Vaccine 2D Barcode Scanning Implementation Toolkit, Vaccine Management Business Improvement Project (VMBIP), Comprehensive Clinic Assessment Software Application (CoCASA), U.S. Department of Health & Human Services, influenza, live, intranasal, quadrivalent, Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use, influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, 0.5 mL dosage, for intramuscular use, Influenza, injectable, quadrivalent, preservative free, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use, Influenza virus vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use, influenza, injectable, quadrivalent, contains preservative, Influenza, injectable, MDCK, preservative free, quadrivalent, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0.5 mL dosage, for intramuscular use, influenza, recombinant, quadrivalent,injectable, preservative free, Influenza virus vaccine, quadrivalent (RIV4), derived from recombinant DNA, hemagglutinin (HA) protein only, preservative and antibiotic free, for intramuscular use, Influenza, injectable, MDCK, quadrivalent, preservative, Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use, FLUZONE High-Dose Quadrivalent Northern Hemisphere, Influenza virus vaccine (IIV), split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use, Influenza vaccine, quadrivalent, adjuvanted, Influenza virus vaccine, quadrivalent (aIIV4), inactivated, adjuvanted, preservative free, 0.5 mL dosage, for intramuscular use, influenza, Southern Hemisphere, pediatric, preservative free, influenza, Southern Hemisphere, preservative free, influenza, Southern Hemisphere, quadrivalent, with preservative, influenza, Southern Hemisphere, high-dose, quadrivalent, FLUZONE High-Dose Quadrivalent Southern Hemisphere, Centers for Disease Control and Prevention. In Study 3 (NCT00988143, see http://clinicaltrials.gov), a multi-centered randomized, open-label trial conducted in the US, adults 18 years of age and older received one dose of either Fluzone Quadrivalent or one of two formulations of comparator trivalent influenza vaccine (TIV-1 or TIV-2). Samson et al. The Lancet Respiratory Medicine. The most commonly reported unsolicited non-serious adverse events were cough, vomiting, and pyrexia. Syncope (fainting) has been reported following vaccination with Fluzone Quadrivalent. In children 3 years through 8 years of age, the most common (10%) injection-site reactions were pain (67%), erythema (34%), and swelling (25%); the most common solicited systemic adverse reactions were myalgia (39%), malaise (32%), and headache (23%). In adults 18 years and older, the most common side effects were pain where you got the shot; muscle aches, headache, and general discomfort. https://doi.org/10.1016/j.vaccine.2020.09.004. Study 1 (NCT01240746, see http://clinicaltrials.gov) was a single-blind, randomized, active-controlled multi-center safety and immunogenicity study conducted in the US. History of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of most IIVs and LAIV4. Fluzone Quadrivalent (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. Influenza virus strains were selected based on the influenza vaccine production method; egg-based and cell- or recombinant based. Participants were 18 through 49 years of age (mean age was 23.3 years); 63.3% were female, 83.1% were Caucasian, and 16.9% were of other racial/ethnic groups. Single-dose vial, 0.5 mL (NDC 49281-422-58) (not made with natural rubber latex). Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Call Us. Fluzone Quadrivalent/NDC 49281-422-88 Study 4 included 602 subjects 50 through 64 years of age for safety analysis, randomized to receive Flublok (n=300) or another U.S.-licensed trivalent influenza vaccine (Fluzone, manufactured by Sanofi Pasteur, Inc.) as an active control (n=302). Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed / Inactivated Poliovirus / Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, Preservative Free. Cases of influenza were identified through active and passive surveillance and confirmed by cell culture and/or real-time polymerase chain reaction (PCR). In Study 4 (NCT01218646) [see Adverse Reactions (6.1)], 660 adults 65 years of age and older were included in the per-protocol immunogenicity analysis. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2020-2021 vaccines, and the availability of candidate strains and reagents. If you wish to continue to this external website, click Proceed. Vaccines manufactured by MedImmune (AstraZeneca), Pfizer, Merck and Bio CSL have the same lot number on their UoS and UoU so this issue does not have an impact on any of their vaccines. Data are not available to assess the effects of Fluzone Quadrivalent on the breastfed infant or on milk production/excretion. Generic Drug Name. Sanofi Pasteur #49281040010 Adacel Tdap Vaccine Indicated for People 10 to 64 Years of Age Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed, Preservative Free Injection Single-Dose Vial 0.5 mL ADACEL TDAP ADLT VACCINE, SDV 2-2.5-5M.5ML (10/BX) Compare Features pain, redness, and swelling where you got the shot. Fluzone is a registered trademark of Sanofi Pasteur Inc. Disease-associated Maternal and/or Embryo/Fetal Risk. For information on flu vaccine distribution schedules, please contact the manufacturers directly. Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine. Influenza-like illness was defined as an illness with at least 1 respiratory symptom (cough or nasal congestion) and at least 1 constitutional symptom (fever or feverishness, chills, or body aches). References1Flublok Quadrivalent [Prescribing Information]. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Chang LJ, et al. Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are vaccines indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Non-inferiority of the 0.5 mL dose(s) relative to the 0.25 mL dose(s) of Fluzone Quadrivalent was demonstrated for all four strains based on pre-specified criteria (lower limit of the 2-sided 95% CI of the ratio of GMTs between groups > 0.667; lower limit of the 2-sided 95% CI of the difference in seroconversion rates >-10%). If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. 8Grohskoph L. Influenza Vaccines for Persons Aged 65 Years: Evidence to Recommendations (EtR) Framework. DO NOT FREEZE. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. Fluzone Quadrivalent is a suspension for injection. Vaccination with Fluzone Quadrivalent may not protect all recipients. ", About the Composition of Sanofi's 2022-2023 Licensed and Approved Influenza Vaccines, Each year, the FDA, World Health Organization (WHO), Centers for Disease Control and Prevention, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.9 Once strains are selected, flu vaccine manufacturers include the newly selected flu strains in their FDA-approved vaccines, and then submit applications to the FDA to include the new flu strains in their FDA-approved vaccines, including for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent and Fluzone Quadrivalent.9 Today those requests for licensure were approved for the upcoming 2022-2023 flu season.5, About Fluzone Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone High-Dose Quadrivalent (Influenza Vaccine). Participants were monitored for unsolicited adverse events for 28 days after each dose and serious adverse events (SAEs) during the 6 months following the last dose. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2021. What are the possible side effects of Fluzone Quadrivalent? BRIDGEWATER, N.J., July 1, 2022 /PRNewswire/ -- Today the US Food and Drug Administration (FDA) approved Sanofi's licensure request for vaccine approval for the upcoming 2022-2023 flu season, including: Fluzone High-Dose Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone Quadrivalent (Influenza Vaccine).5 This approval comes on the heels of the CDC's Advisory Committee on Immunization Practices (ACIP) preferential recommendation for adults 65+ including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent.6 Following this licensure, Sanofi will begin to ship their vaccines helping to ensure more people, including some of our most vulnerable population of 65 years and older, will be immunized with the vaccine best suited for their needs as recommended by the ACIP. The effectiveness of Fluzone Quadrivalent was demonstrated based on clinical endpoint efficacy data for Fluzone (trivalent influenza vaccine) and on an evaluation of serum HI antibody responses to Fluzone Quadrivalent. 1 This was the impetus for the 1994 federal. The intent-to-treat analysis set included 1138 healthy adults who received Fluzone or placebo. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Influenza Vaccine for the 2020-2021 Season Cumulative 2020/2021 Season Lot Release Status (Updated 2/24/2021) Flu vaccine lots that have been released by FDA and are available for. Strength. The distribution of demographic characteristics was similar to that of the safety analysis set [see Adverse Reactions (6.1)]. E, 10 Single-Dose The dose and schedule for Fluzone Quadrivalent are presented in Table 1. The most commonly reported adverse events were oropharyngeal pain, rhinorrhea, injection-site induration, and headache. Throughout the study period, a total of 41 (1.4%) recipients in the Fluzone Quadrivalent group, 7 (1.0%) recipients in the TIV-1 group, and 14 (1.9%) recipients in the TIV-2 group, experienced at least one SAE. All information these cookies collect is aggregated and therefore anonymous. Annual influenza vaccination is recommended. Fluzone Quadrivalent is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following four influenza strains recommended for the 2022-2023 influenza season: A/Victoria/2570/2019 IVR-215 (H1N1), A/Darwin/9/2021 SAN-010 (H3N2), B/Phuket/3073/2013 (B Yamagata lineage), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The following events have been spontaneously reported during the post-approval use of Fluzone (trivalent) or Fluzone Quadrivalent. The new facility building at Swiftwater has had an investment of $150m. 3) Multi-dose vial, 5 mL, for persons 6 months of age and older. McKesson Acceptable Dating: we will ship >= 30 days. FDA-approved patient labeling (Patient Information), "-" Indicates information is not applicable, Not previously vaccinated with influenza vaccine or unknown vaccination history, Previously vaccinated with influenza vaccine, If two doses, administer at least 4 weeks apart, Sodium phosphate-buffered isotonic sodium chloride solution, INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/DARWIN/9/2021 SAN-010 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MICHIGAN/01/2021 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/GUANGDONG-MAONAN/SWL1536/2019 CNIC-1909 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/WASHINGTON/02/2019 HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/MICHIGAN/45/2015 X-275 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/TASMANIA/503/2020 IVR-221 (H3N2) HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED). For participants who received two doses, the doses were administered approximately 4 weeks apart. Among participants in the three vaccine groups combined, 67.2% were female (Fluzone Quadrivalent, 68.4%; TIV-1, 67.9%; TIV-2, 65.3%), 88.4% Caucasian (Fluzone Quadrivalent, 91.1%; TIV-1, 86.8%; TIV-2, 87.4%), 9.6% Black (Fluzone Quadrivalent, 6.8%; TIV-1, 12.1%; TIV-2, 10.0%), 0.4% Hispanic (Fluzone Quadrivalent, 0.0%; TIV-1, 0.5%; TIV-2, 0.5%), and 1.7% were of other racial/ethnic groups (Fluzone Quadrivalent, 2.1%; TIV-1, 0.5%; TIV-2, 2.2%). The safety analysis set included 1841 children 6 months through 35 months of age and 2506 children 3 years through 8 years of age. HI antibody GMTs 21 days following vaccination with Fluzone Quadrivalent were non-inferior to those following each TIV for all four strains, based on pre-specified criteria (see Table 12). Each of the trivalent formulations contained an influenza type B virus that corresponded to one of the two type B viruses in Fluzone Quadrivalent (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Abbreviations: ACIP = Advisory Committee on Immunization Practices; FDA = Food and Drug Administration; HA = hemagglutinin; IIV3 = inactivated influenza vaccine, trivalent; IIV4 = inactivated influenza vaccine, quadrivalent; IM = intramuscular; LAIV4 = live attenuated influenza vaccine, quadrivalent; MDV = multidose vial; NAS = intranasal; PFS = prefilled syringe; RIV4 = recombinant influenza vaccine, quadrivalent; SDV = single-dose vial. Medically reviewed by Drugs.com. Influenza Vaccine for the 2021-2022 Season Cumulative 2021/2022 Season Lot Release Status (Updated 11/3/2021) Flu vaccine lots that have been released by FDA and are available for. What better way to launch Our Stories than to learn about us through the words of our people. ACIP General Best Practice Guidelines for Immunization. Before administering a dose of vaccine, shake the prefilled syringe or vial. In Study 2 (NCT02915302) [see Adverse Reactions (6.1)], 1027 children, 6 months through 35 months of age, were included in the per-protocol immunogenicity analysis. The most commonly reported unsolicited non-serious adverse events were headache, cough, and oropharyngeal pain. This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Thank you for taking the time to confirm your preferences. Available at https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm. Please refer to the full Prescribing Information forFluzone High-Dose Quadrivalent, Flublok Quadrivalent, orFluzone Quadrivalent. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. In children 6 months through 35 months of age receiving a 0.25 mL dose of Fluzone Quadrivalent in Study 1 (NCT01240746, see http://clinicaltrials.gov), the most common (10%) injection-site reactions were pain (57%)1 or tenderness (54%)2, erythema (37%), and swelling (22%); the most common solicited systemic adverse reactions were irritability (54%)2, abnormal crying (41%)2, malaise (38%)1, drowsiness (38%)2, appetite loss (32%)2, myalgia (27%)1, vomiting (15%)2, and fever (14%). Questions: Toll-free: 877-2Get-VFC (877-243-8832) an A/Victoria/2570/2019 (H1N1) pdm09-like virus; an A/Cambodia/e0826360/2020 (H3N2)-like virus; a B/Washington/02/2019- like virus (B/Victoria lineage); a B/Phuket/3073/2013-like virus (B/Yamagata lineage). Do not administer this product intravenously, intradermally, or subcutaneously. For intramuscular injection only, Afluria, Afluria Quadrivalent, Flucelvax Quadrivalent, Fluad, +7 more, Tamiflu, oseltamivir, Fluzone, Xofluza, Afluria, influenza virus vaccine, inactivated. Supplied as package of 10 (NDC 49281-422-50). COVID-19 Vaccine Lot Number and Expiration Date Tool Seasonal Influenza Codes and Crosswalk This new format includes all seasonal influenza vaccines for the 2022/2023 season in a single Excel crosswalk table that provides the CVX, MVX, NDC Unit of Sale, NDC Unit of Use, and CPT (*) codes for each vaccine. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. Flublok Quadrivalent STN: 125285 Proper Name: Influenza Vaccine Tradename: Flublok Quadrivalent Manufacturer: Protein Sciences Corporation Indication: For active immunization against. Swiftwater, PA 18370 USA. Influenza (seasonal) Fact Sheet. If you have questions or would like more information, please talk with your healthcare provider. In this study, children 6 months through 35 months of age received one or two 0.25 mL doses of either Fluzone Quadrivalent or one of two formulations of a comparator trivalent influenza vaccine (TIV-1 or TIV-2), and children 3 years through 8 years of age received one or two 0.5 mL doses of either Fluzone Quadrivalent, TIV-1, or TIV-2. Sanofi Pharma; Sanofi Genzyme; Sanofi Pasteur; Our data sharing commitments; Managed Access Programs (MAPs) . Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY, Media RelationsEvan Berland| + 1 215 432 0234 | [email protected] Bain| + 1 781 264 1091 | [email protected] Conway| + 1 617 981 2738 | [email protected], Investor RelationsEva Schaefer-Jansen|+ 33 7 86 80 56 39 |[email protected] Delpine|+ 33 6 73 69 36 93 | [email protected] Corentine Driancourt|+ 33 6 40 56 92 21 | [email protected] Lauscher|+ 1908612 7239 | [email protected] Nanduri|+1 617 764 6418| [email protected] Pham|+ 33 7 85 93 30 17 | [email protected]. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. If a prefilled syringe of Fluzone Quadrivalent is used for a child in this age group, the dose volume will be 0.5mL per dose. Study 2 included 602 subjects 50 through 64 years of age for safety analysis, randomized to receive Flublok (n=300) or another U.S.-licensed trivalent influenza vaccine (Fluzone, manufactured by Sanofi Pasteur, Inc.) as an active control (n=302) (2) (see Clinical Studies ). The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton X-100), producing a "split virus". Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. To receive weekly email updates about Seasonal Flu, enter your email address: We take your privacy seriously. Healthcare providers are encouraged to enroll women who receive Fluzone Quadrivalent during pregnancy in Sanofi Pasteur Inc.'s vaccination pregnancy registry by calling 1-800-822-2463. See FDA-approved patient labeling (Patient Information). In Study 3 (NCT00988143) [see Adverse Reactions (6.1)], 565 adults 18 years of age and older who had received one dose of Fluzone Quadrivalent, TIV-1, or TIV-2 were included in the per-protocol immunogenicity analysis. Table 4 summarizes solicited injection-site and systemic adverse reactions reported within 7 days post-vaccination via diary cards for the 0.25 mL and 0.5 mL volumes of Fluzone Quadrivalent in children 6 months through 35 months of age. Investigator Sponsored Studies and Externally Sponsored Collaboration, Access to Quality Healthcare Sanofi Global Health, Contributing to the eradication, elimination and control of some infectious diseases, Serving the needs of patients with non-communicable diseases, Development opportunity: how Sanofi empowers you, Influenza vaccination can reduce the risk of heart attacks by up to 45% [15-45%], Vaccination is especially important for people most at risk, Flu and Covid-19 vaccines can be administered at the same time, That means not only using mRNA or protein-based technologies, but also, We are currently innovating in our existing different technologies including egg-based flu vaccines, recombinant proteins, mRNA to develop and deliver vaccines that can. You can ask your healthcare provider for a list of other side effects that is available to healthcare professionals. You should not get Fluzone Quadrivalent if you: Tell your healthcare provider if you or your child have or have had: Fluzone Quadrivalent is a shot given into the muscle of the arm. While patients can receive vaccinations from a variety of sources, offering them within the "medical home" leads to increased immunization rates. In addition, HI antibody GMTs and seroconversion rates following Fluzone Quadrivalent were higher than those following TIV for the B strain not contained in each respective TIV based on pre-specified criteria (the lower limit of the 2-sided 95% CI of the ratio of the GMTs [Fluzone Quadrivalent divided by TIV] >1.5 for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV and the lower limit of the two 2-sided 95% CI of the difference of the seroconversion rates [Fluzone Quadrivalent minus TIV] >10% for each B strain in Fluzone Quadrivalent compared with the corresponding B strain not contained in each TIV). A maximum of ten doses can be withdrawn from the multi-dose vial. Not all formulations are available from the VFC Program. Package insert / product label Sanofi assumes no responsibility for the information presented on this website. The Fluzone Quadrivalent prefilled syringe and vial presentations are not made with natural rubber latex. Seroconversion rates 21 days following Fluzone Quadrivalent were non-inferior to those following TIV for H3N2, B/Brisbane, and B/Florida, but not for H1N1 (see Table 14). Available at https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf. 3). Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone (trivalent) or Fluzone Quadrivalent. problems with your immune system as the immune response may be diminished. The difference in fever rate (Group 2 minus Group 1) was 0.84% (95% CI: -2.13%; 3.80%), meeting the prespecified non-inferiority criterion (upper limit of the 2-sided 95% CI of the difference in fever rates <5%). Fluzone High-Dose Quadrivalent is given to people 65 years of age and older. Three SAEs were considered to be possibly related to vaccination: croup in a Fluzone Quadrivalent recipient and 2 episodes of febrile seizure, 1 each in a TIV-1 recipient and a TIV-2 recipient. A randomized, double-blind, placebo-controlled study was conducted at a single US center during the 1999-2000 (Year 1) and 2000-2001 (Year 2) influenza seasons. Cookies used to make website functionality more relevant to you. Selecting Viruses for the Seasonal Influenza Vaccine. We are pursuingnext generationinfluenza vaccines with multiple vaccine technologies to develop and bring forward tomorrows vaccines to people around the world as fast as possible. Please read this information sheet before getting Fluzone Quadrivalent. COVID-19 Vaccine Lot Number and Expiration Date Tool. Safety and immunogenicity of Fluzone Quadrivalent were evaluated in adults 65 years of age and older. Discard if vaccine has been frozen. You will be subject to the destination website's privacy policy when you follow the link. The latest UKHSA data on the maternal whooping cough vaccine programme shows that uptake has dropped to its lowest level in 7 years. Influenza Surveillance Report (FluView), Previous Forecasts for the 2021-2022 Season, Tools to Prepare Your Practice for Flu Season, Information for Clinicians on Influenza Virus Testing, Multiplex Assays Authorized for Simultaneous Detection of Influenza Viruses and SARS-CoV-2, Information on Collection of Respiratory Specimens for Influenza Virus Testing, Information for Clinicians on Rapid Diagnostic Testing for Influenza, Information on Rapid Molecular Assays, RT-PCR, and other Molecular Assays for Diagnosis of Influenza Virus Infection, Algorithm: Interpreting Influenza Testing Results When Influenza is Circulating, Algorithm: Interpreting Influenza Testing Results When Influenza is NOT Circulating, Guide: Influenza Diagnostic Testing in Closed Setting Outbreaks, Guidance: Standard-Based Electronic Laboratory Reporting, Guidance: Antiviral and Obstetric Health Care, Guidance: Outbreak Management in Long-Term Care Facilities, Guidance: Use of Mask to Control Influenza Transmission, Guidance: Prevention & Control in Peri- and Postpartum Settings, U.S. Department of Health & Human Services, Standard dose, cell culture based (ccIIV4), Standard dose, egg based with MF59 adjuvant (aIIV4), Standard dose, egg based with MF59 adjuvant (aIIV3), 0.2-mL prefilled single-use intranasal sprayer. Medical professionals, medical facility employees 855.571.2100. 9Centers for Disease Control and Prevention. Fluzone Quadrivalent is approved for use in persons 6 months of age and older. 47823. They help us to know which pages are the most and least popular and see how visitors move around the site. Participants were monitored for unsolicited adverse events and SAEs during the 28 days following vaccination. For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common side effects were tenderness, and/or pain where you got the shot; headache, tiredness, muscle aches, and joint pain. Prefilled Syringes Before sharing sensitive information, make sure you're on a federal government site. Antibiotics are not used in the manufacture of Fluzone Quadrivalent. 800.422.0280. 2021 Dec 6;73(11):e4288-e4295. Participants received two 0.25 mL doses of either Fluzone (N = 525) or a placebo (N = 261).
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