A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant

Start Date01 Apr 2025

Sponsor / Collaborator-

NCT05170399

/ RecruitingPhase 4IIT

Vaccine Responses in Patients With B Cell Malignancies

Background:
People with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.
Objective:
To learn how well vaccines work in people who have certain types of blood cancers.
Eligibility:
Adults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.
Design:
Participants will get one or more vaccines for illnesses such as COVID-19, hepatitis B, and shingles. They can choose which vaccines they receive. They will give a blood sample before they get each vaccine. Some vaccines require a second dose 3-6 weeks later. Participants may give an optional blood sample with the second vaccine dose. About 4 weeks after they finish each vaccine series, they will give another blood sample. They will have 2-3 study visits per vaccine.
Participants may receive a booster dose for some vaccines. The booster dose is optional. They will give another blood sample with the booster dose.
Participants will have pregnancy tests, if needed.
Participants with CLL who receive BTKis may be asked to pause treatment for up to 7 weeks.
Participants may give follow-up blood samples up to 2 times a year for 5 years. These blood samples are optional.
Participation will last for up to 5 years after each vaccine series is received.

Start Date14 Sep 2022

Sponsor / Collaborator

National Heart, Lung & Blood Institute

CTRI/2022/05/042514

/ CompletedPhase 3

A prospective, randomized, two arm, parallel, activecontrolled, multicentre, phase III clinical study tocompare the immunogenicity and safety of InactivatedInfluenza vaccine (split virion) I.P. (Tetravalent) 0.5mlof M/s Cadila Healthcare Limited with Fluarix-Tetra ofM/s GlaxoSmithKline Pharmaceuticals Limited inhealthy children aged 6 to 35 months

Start Date15 May 2022

Sponsor / Collaborator-

100 Clinical Results associated with Inactivated quadrivalent influenza vaccine (Seqirus GmbH)

100 Translational Medicine associated with Inactivated quadrivalent influenza vaccine (Seqirus GmbH)

100 Patents (Medical) associated with Inactivated quadrivalent influenza vaccine (Seqirus GmbH)

Literatures (Medical) associated with Inactivated quadrivalent influenza vaccine (Seqirus GmbH)

04 Feb 2025·JOURNAL OF INFECTIOUS DISEASES

Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial

Article

Author: Lee, Ivan T ; Henry, Carole ; Nachbagauer, Raffael ; McGrath, Shannon ; Chen, Ren ; Choi, Angela ; Kuo, Hsiao-Hsuan ; Huang, Wenmei ; Stadlbauer, Daniel ; Paris, Robert ; Ensz, David ; Avanesov, Andrei ; Pucci, Alicia ; Schaefers, Kristi ; Ananworanich, Jintanat ; Carmona, Lizbeth

Abstract:

Background:

Seasonal influenza remains a global public health concern. A messenger RNA (mRNA)–based quadrivalent seasonal influenza vaccine, mRNA-1010, was investigated in a first-in-human, phase 1/2 clinical trial conducted in 3 parts.

Methods:

In parts 1 to 3 of this stratified observer-blind study, adults aged ≥18 years were randomly assigned to receive a single dose (6.25–200 µg) of mRNA-1010 or placebo (part 1) or an active comparator (Afluria; parts 2 and 3). Primary study objectives were assessment of safety, reactogenicity, and humoral immunogenicity of mRNA-1010, placebo (part 1), or active comparator (parts 2 and 3). Exploratory end points included assessment of cellular immunogenicity (part 1) and antigenic breadth against vaccine heterologous strains (A/H3N2; parts 1 and 2).

Results:

In all study parts, solicited adverse reactions were reported more frequently for mRNA-1010 than placebo or Afluria, and most were grade 1 or 2 in severity. No vaccine-related serious adverse events or deaths were reported. In parts 1 and 2, a single dose of mRNA-1010 (25–200 µg) elicited robust day 29 hemagglutination inhibition titers that persisted through 6 months. In part 3, lower doses of mRNA-1010 (6.25–25 µg) elicited day 29 hemagglutination inhibition titers that were higher or comparable to those of Afluria for influenza A strains. When compared with Afluria, mRNA-1010 (50 µg) elicited broader A/H3N2 antibody responses (part 2). mRNA-1010 induced greater T-cell responses than placebo at day 8 that were sustained or stronger at day 29 (part 1).

Conclusions:

Data support the continued development of mRNA-1010 as a seasonal influenza vaccine.

Clinical Trials Registration:

NCT04956575 (https://clinicaltrials.gov/study/NCT04956575).

01 Nov 2020·Supportive care in cancer : official journal of the Multinational Association of Supportive Care in CancerQ2 · MEDICINE

Efficacy of influenza vaccine (Fluvax) in cancer patients on treatment: a prospective single arm, open-label study

Q2 · MEDICINE

Article

Author: Roy, A ; Kichenadasse, G ; Sukumaran, S ; Vatandoust, S ; Richards, A ; Quinn, S ; Honda-Okubo, Y ; Gordon, D ; Kumar, R ; Mead, K ; Jain, K ; Ayoola, A ; Karapetis, C ; Koczwara, B

PURPOSE:

Influenza virus infection has significant morbidity and mortality in patients with medical co-morbidities who are also immunosuppressed. The efficacy of the seasonal influenza vaccine has not been well studied in patients receiving chemotherapy. We assessed the efficacy of seasonal influenza vaccine in patients with non-haematological malignancy on active treatment (chemotherapy and targeted therapy).

METHODS:

A prospective single arm, open label study with 53 patients with non-haematological cancers recruited during the 2011 and 2012 influenza seasons. Participants had one dose of 2011/2012 trivalent vaccine containing strains A/California/7/2009(H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 (Fluvax) prior to or in-between treatment cycles. Haemagglutination inhibition antibody (HIA) titres in serum were measured at baseline 3, 6 and 24 weeks. Primary endpoint: seroconversion rate (SCR) at 3 weeks. Secondary endpoints: late SCR at 6 weeks. rate of sustained sero-protection titres (SPR) at 24 weeks. Seroconversion was defined as postvaccination ≥ 4-fold increase in HIA titre and sero-protection defined as a HIA ≥ 1:40.

RESULTS:

The SCR at 3 weeks were 35%, 30% and 22.5% to the H1N1, H3N2 and B/Bris strains, respectively. There were no new cases of late SC at 6 weeks or 24 weeks. The SPR at 3 weeks were 72.5%, 65% and 40%, respectively, to H1N1, H3N2 and B/Bris. The SPR at 24 weeks to H1N1, H3N2 and B/Bris were 40%, 52.5% and 17.5%, respectively.

CONCLUSIONS:

Patients on various solid tumour treatments achieve sero-protection rate congruent with the general population. The sero-protection HIA titres were not sustained at 24 weeks postvaccination.

15 Oct 2020·AMERICAN FAMILY PHYSICIAN

Influenza Vaccination: Updated 2020-2021 Recommendations from ACIP.

Article

Author: Carrie Armstrong ; Armstrong, Carrie

Updates this year include the antigenic composition of seasonal influenza vaccines available in the United States, the addition of two new influenza vaccines for use in people 65 years and older, and new contraindications and precautions for the use of live attenuated influenza vaccine (LAIV) Because the 2020–2021 influenza season will coincide with the coronavirus disease 2019 (COVID-19) pandemic, vaccination of people six months and older is of particular importance to reduce symptoms that could be confused with those of COVID-19 and to alleviate stress on the health care system Influenza Vaccines—United States, 2020–2021 Influenza Season Trade name Formulation Age indication Hemagglutinin or virus count per vaccine virus (per dose) Route of administration Mercury from thimerosal (mcg per 0 5 mL) IIV4, standard dose, egg based* Afluria Quadrivalent 0 25-mL prefilled syringe† 6 to 35 months 7 5 mcg per 0 25 mL IM‡ — 0 5-mL prefilled syringe† ≥ 3 years 15 mcg per 0 5 mL IM‡ — 5 0-mL multidose vial† ≥ 6 months (needle/syringe) 7 5 mcg per 0 25 mL/15 mcg per 0 5 mL IM‡ 24 5 18 to 64 years (jet injector) Fluarix Quadrivalent 0 5-mL prefilled syringe ≥ 6 months 15 mcg per 0 5 mL IM‡ — Flulaval Quadrivalent 0 5-mL prefilled syringe ≥ 6 months 15 mcg per 0 5 mL IM‡ — Fluzone Quadrivalent 0 5-mL prefilled syringe§ ≥ 6 months 15 mcg per 0 5 mL IM‡ — 0 5-mL single-dose vial ≥ 6 months 15 mcg per 0 5 mL IM‡ — 5 0-mL multidose vial ≥ 6 months 15 mcg per 0 5 mL IM‡ 25 IIV4, standard dose, cell culture based Flucelvax 0 5-mL prefilled syringe ≥ 4 years 15 mcg per 0 5 mL IM‡ — Quadrivalent 5 0-mL multidose vial ≥ 4 years 15 mcg per 0 5 mL IM‡ 25 IIV4, high dose, egg based* Fluzone High-Dose Quadrivalent 0 7-mL prefilled syringe ≥ 65 years 60 mcg per 0 7 mL IM‡ — IIV4, standard dose, egg based* with MF59 adjuvant Fluad Quadrivalent 0 5-mL prefilled syringe ≥ 65 years 15 mcg per 0 5 mL IM‡ — IIV3, standard dose, egg based* with MF59 adjuvant Fluad 0 5-mL prefilled syringe ≥ 65 years 15 mcg per 0 5 mL IM‡ — Recombinant influenza vaccine Flublok Quadrivalent 0 5-mL prefilled syringe ≥ 18 years 45 mcg per 0 5 mL IM‡ — Live attenuated influenza vaccine, egg based* Flumist Quadrivalent 0 2-mL prefilled single-use intranasal sprayer 2 to 49 years 106 5–7 5 fluorescent focus units per 0 2 mL Intranasal — Note: Vaccination providers should consult prescribing information for 2020–2021 influenza vaccines for the most complete and updated information Higher-risk people: ○ Adults 50 years and older ○ American Indians/Alaska Natives ○ Children six to 59 months of age ○ Children up to 18 years of age who are receiving aspirin- or salicylate-containing medications (risk of Reye syndrome after influenza virus infection) ○ Immunocompromised people ○ People with a body mass index of 40 kg per m2 or greater ○ People with chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic, or metabolic disorders other than uncomplicated hypertension ○ Pregnant women ○ Residents of long-term care facilities Household contacts and caregivers of higher-risk people Health care professionals, including students and staff who could be exposed to infectious agents Guideline source:

News (Medical) associated with Inactivated quadrivalent influenza vaccine (Seqirus GmbH)

09 Jul 2024

·www.prnewswire.com

CSL Seqirus Begins Shipping Its Portfolio of Influenza Vaccines for the 2024/25 Flu Season

CSL Seqirus is the only manufacturer to offer a differentiated influenza vaccine for all eligible people aged six months and older in the United States. Centers for Disease Control and Prevention (CDC) trend findings indicate a significant decline in influenza vaccination rates, which poses a serious risk to public health infrastructure and underscores the importance of receiving an annual influenza vaccination.1,2 According to the CDC, it is recommended that all eligible people aged six months and older receive their annual influenza vaccine, especially people at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.2,3 SUMMIT, N.J., July 9, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced that it has commenced shipping its differentiated portfolio of influenza vaccines. This year, the company's influenza vaccines are being produced as trivalent influenza vaccine (TIV) formulations, in compliance with the U.S. Food and Drug Administration's (FDA) directive to remove the B/Yamagata strain.4 "We are proud to support healthcare providers in their efforts to vaccinate their patients and communities to help turn around concerning declines in seasonal influenza vaccination rates," said Stefan Merlo, Vice President of Commercial Operations, North America, CSL Seqirus. "We are a committed partner in public health and are doing our part to educate, inform, and meet the evolving needs of the public, ensure customers are prepared for the upcoming flu season, and help reverse this downward trend to restore vaccination rates." This season, the 2024/25 influenza vaccine portfolio for CSL Seqirus, the only manufacturer to offer a differentiated influenza vaccine option approved for use in people aged six months and older, includes: FLUCELVAX® (Influenza Vaccine), the first and only cell-based influenza vaccine indicated for use in people six months and older.5 FLUAD® (Influenza Vaccine, Adjuvanted), the first and only adjuvanted seasonal influenza vaccine for adults 65 and older, which is preferentially recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) over standard-dose influenza vaccines.6,7 FLUAD contains an MF59® adjuvant that is designed to strengthen, broaden, and lengthen the immune response when added to an influenza vaccine.6,8,9 AFLURIA® (Influenza Vaccine), an egg-based, influenza vaccine approved for use in eligible people six months of age and older.10 The impact of declining vaccination rates poses a serious risk to public health infrastructure, with preliminary estimates from the CDC reporting an increase in influenza-related hospitalizations and deaths last season, in comparison to seasons prior, as well as an overburdened healthcare system.11,12 Across all age cohorts, vaccination rates experienced double-digit percentage declines over the past three flu seasons according to internal calculations based on influenza tracking data.13 This includes a notable 22% drop among children aged 6 months to 18 years and a 14% decrease in adults over 65, a group that typically maintains stable immunization rates.13 Additionally, the public health burden of influenza outpaces other respiratory illness.11,14,15 During the 2023/24 flu season, influenza accounted for nearly half of hospitalizations attributed to infectious diseases including influenza, COVID and respiratory syncytial virus (RSV) combined and over half of total deaths.11,14,15 This data underscores the importance of the CDC's recommendation that all eligible people aged six months and older receive an annual influenza vaccination as an essential measure to help prevent influenza and its complications.2 This is especially important for those at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.3 "Influenza continues to pose a significant threat, as evidenced by recent flu seasons," said Dr. Gregg Sylvester, Chief Health Officer, CSL Seqirus. "As we begin distributing influenza vaccines to healthcare providers throughout the U.S., it is imperative that we work to maintain high vaccination rates this season to help reduce the burden of influenza-related illnesses and the risk of severe outcomes." For additional information on our influenza vaccines for the upcoming flu season as well as resources about vaccination campaigns and CDC guidance, visit flu360.com. About Seasonal Influenza Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.16 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.16 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.16 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2023/24 influenza season, there were an estimated 390,000-810,000 influenza-related hospitalizations in the U.S.11 The CDC recommends annual vaccination for people aged six months and older, who do not have any contraindications.2 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.2 The CDC recommends that for most people who need only 1 dose of flu vaccine, vaccination should ideally happen in September or October.2 About CSL Seqirus CSL Seqirus is part of CSL (ASX: CSL). As a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus offers a broad portfolio of innovative, differentiated vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit . About CSL CSL (ASX: CSL; USOTC: CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit . Intended Audience This press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products. Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. USA-CRP-24-0016 MEDIA CONTACT Tiffany Cody +1 (908) 370-1863 [email protected] FLUAD ® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine) IMPORTANT SAFETY INFORMATION What are FLUAD® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine)? FLUAD is a vaccine that helps protect people aged 65 years and older from the flu. FLUCELVAX and AFLURIA are vaccines that helps protect people aged 6 months and older from the flu. Vaccination with any of these may not protect all people who receive the vaccine. Who should not receive FLUAD, FLUCELVAX, or AFLURIA? You should not receive FLUAD nor AFLURIA if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. You should not receive FLUCELVAX if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine. Before receiving FLUAD, FLUCELVAX, or AFLURIA, tell your healthcare provider about all medical conditions, including if you: have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give any flu vaccine should be made by your healthcare provider, based on careful consideration of the potential benefits and risks have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine have ever fainted when receiving a vaccine What are the most common side effects of FLUAD, FLUCELVAX, and AFLURIA? pain, tenderness, redness, itching, bruising, and/or swelling where the vaccine was given headache extreme tiredness muscle aches feeling unwell (malaise) Additional side effects seen in children include: raised hardened area where the vaccine was given changes in eating habits/loss of appetite sleepiness irritability diarrhea These are not all the possible side effects of FLUAD, FLUCELVAX, and AFLURIA. You can ask your healthcare provider for more information and for advice about any side effects that concern you. What do I do if I have side effects? Report any severe or unusual side effects to your healthcare provider . To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or . Before receiving any of these vaccines, please see the full US Prescribing Information for FLUAD, FLUCELVAX, or AFLURIA. You can ask your healthcare provider or pharmacist for information about FLUAD, FLUCELVAX, or AFLURIA that is written for healthcare professionals. REFERENCES 1 Centers for Disease Control and Prevention (CDC). Flu Vaccination Coverage Update. Retrieved from: . Accessed June 2024. 2 CDC. Who Needs a Flu Vaccine and When. Retrieved from: . Accessed June 2024. 3 CDC. People at Higher Risk of Flu Complications. . Accessed June 2024. 4 Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. 184th Vaccines and Related Biological Products Advisory Committee. March 2024. Retrieved from: . Accessed June 2024. 5 FLUCLEVAX. Package Insert. CSL Seqirus Inc. 6 FLUAD. Package Insert. CSL Seqirus Inc. 7 Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023–24 Influenza Season. MMWR Recomm Rep 2023;72(No. RR-2):1–25. DOI: . 8 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034. 9 O'Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines: 2013;12(1): 13-3. 10 AFLURIA. Package Insert. CSL Seqirus Inc. 11 CDC. 2023-2024 Preliminary In-Season Burden Estimate. Retrieved from: . Accessed June 2024. 12 CDC. Disease Burden of Flu. Retrieved from: . Accessed June 2024. 13 IQVIA PharMetrics Plus Administrative Claims Database. 14 CDC. RSV Surveillance & Research. Retrieved from: . Accessed June 2024. 15 CDC. COVID Data Tracker. . Accessed June 2024. 16 CDC. Key Facts about Influenza. Retrieved from . Accessed June 2024. SOURCE CSL Seqirus

VaccineDrug Approval

17 Jul 2023

·www.prnewswire.com

CSL Seqirus Begins Shipping Portfolio of Innovative Influenza Vaccines for the 2023/24 U.S. Season

CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older. Since the COVID-19 pandemic, there has been a significant drop in influenza immunization rates and high levels of influenza-related illness, underscoring that flu is an ongoing threat.1,2 The Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for all eligible people aged six months and older, as a critical tool to help prevent flu and lessen the severity of influenza-related illness and potentially life-threatening associated complications.3 SUMMIT, N.J., July 17, 2023 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX:CSL), today announced it has begun to ship its portfolio of innovative cell-based, adjuvanted and egg-based influenza vaccines across the U.S. in preparation for the 2023/24 influenza season. The company is positioned to supply over 55 million doses of influenza vaccines to healthcare providers across the U.S. "Last season underscored the devastating impact flu can have, with over 300,000 flu-related hospitalizations and 19,000 flu-related deaths reported based on preliminary data through April 2023," said Dr. Gregg Sylvester, Chief Health Officer, CSL Seqirus.2 "This year in the Southern Hemisphere, we're already seeing high levels of influenza activity, especially in children, which has historically been a strong predictor of what's to come in the Northern Hemisphere.4,5 As we commence shipment to healthcare providers across the U.S., it's critical that we raise immunization rates this season to help protect as many people as possible from influenza and its potentially life-threatening complications." CSL Seqirus is the only manufacturer to offer differentiated influenza vaccine options approved for use in individuals six months of age and older. This year's 2023/24 U.S. influenza season portfolio includes: FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine indicated for use in people six months and older.6 By avoiding egg adaptation, cell-based flu vaccines provide an exact antigenic match to the World Health Organization--selected influenza virus strains.7,8,9 There were two real world evidence (RWE) studies conducted by the Marshfield Clinic Research Institute during the 2022/23 Northern Hemisphere season, in which a large majority (84%) of vaccinated participants received FLUCELVAX QUADRIVALENT. Influenza vaccine effectiveness was found to be 54% effective at preventing medical care cases in children and adults six months to 64 years of age, and 71% effective at preventing symptomatic flu among children ages 1 to 17 years of age.10 Limitations of these studies include small sample sizes from a single geographic area and the potential for confounding and bias. FLUCELVAX QUADRIVALENT immunogenicity, efficacy and safety are supported by randomized clinical trials.6 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), the first and only adjuvanted quadrivalent seasonal influenza vaccine for adults 65 years and older, is preferentially recommended by the CDC's Advisory Committee on Immunization Practices (ACIP) over standard-dose influenza vaccines.11,12 FLUAD QUADRIVALENT contains an MF59® adjuvant that, when added to a flu vaccine, is designed to strengthen, broaden, and lengthen the immune response.11,13,14 This is important for adults 65 years and older whose immune systems may have a decreased capacity to respond to flu illness or vaccines. AFLURIA® QUADRIVALENT (Influenza Vaccine), an egg-based, quadrivalent influenza vaccine approved for use in eligible people six months of age and older.15 The CDC recommends annual influenza vaccination for all eligible individuals, ages six months and older, as a critical tool to prevent and lessen the severity of disease.3 Annual influenza vaccination is especially important for people at a higher risk of developing serious influenza-related complications, including older adults, pregnant people and children younger than 5 years old.3,16 According to the CDC, most people who need only one dose of influenza vaccine for the season, should receive their vaccine in September or October.3 For children six months through 8 years of age, who require two vaccine doses, the CDC recommends they receive the first dose as soon as the vaccine is available, as early as July and August.3 For children of any age who need only one dose of flu vaccine or pregnant people in their third trimester, vaccination as early as July and August can also be considered. 3 "It's unfortunate that in a year when we saw an early onset and significant increase in influenza cases from the previous year, especially in children, vaccination rates in the U.S. and globally were so low," said Dave Ross, Vice President, North America Commercial Operations, CSL Seqirus. "Influenza vaccination is critical in reducing flu-related hospitalizations and overall burden of disease.17 At CSL Seqirus, we're committed to working with our public health partners to do what we can to help drive vaccination rates at least back up to pre-pandemic levels." For additional information on influenza vaccine options for the upcoming flu season, visit flu360.com. About Seasonal Influenza Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.17 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.17 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.17 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2022/23 influenza season, there were an estimated 300,000-650,000 influenza-related hospitalizations in the U.S.2 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.3 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.3 The CDC recommends that for most people who need only 1 dose of flu vaccine, vaccination should ideally happen in September or October.3 About CSL Seqirus CSL Seqirus is part of CSL (ASX:CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit CSLSeqirus.com. About CSL CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit . Intended Audience This press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products. Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. USA-CRP-23-0005 MEDIA CONTACT Tiffany Cody +1 (908) 370-1863 [email protected] FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), FLUCELVAX® QUADRIVALENT (Influenza Vaccine), and AFLURIA® QUADRIVALENT (Influenza Vaccine) INDICATION AND IMPORTANT SAFETY INFORMATION What are FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), FLUCELVAX® QUADRIVALENT (Influenza Vaccine), and AFLURIA® QUADRIVALENT (Influenza Vaccine)? FLUAD QUADRIVALENT is a vaccine that helps protect people aged 65 years and older from the flu. FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. AFLURIA QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with any of these may not protect all people who receive the vaccine. Who should not get FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT? You should not get FLUAD QUADRIVALENT nor AFLURIA QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe allergic reaction to a previous influenza vaccine. You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine. Before receiving FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you: have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give any flu vaccine should be made by your healthcare provider, based on careful consideration of the potential benefits and risks. have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine have ever fainted when receiving a vaccine What are common side effects possible with FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, and AFLURIA QUADRIVALENT? pain, tenderness, redness, itching, bruising, swelling, and/or a raised hardened area where the vaccine was given headache overtiredness with low energy muscle aches feeling unwell (malaise) Additional side effects in children include: sleepiness irritability diarrhea changes in eating habits These are not all the possible side effects of FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, and AFLURIA QUADRIVALENT. You can ask your healthcare provider for more information. What do I do if I have side effects? Ask your healthcare provider for advice about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and . You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1–800–FDA–1088. Before receiving this vaccine, please see the full US Prescribing Information for FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT. The information provided here does not include all that is known about FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT. To learn more, talk with your healthcare provider. FLUAD® QUADRIVALENT, FLUCELVAX® QUADRIVALENT, and AFLURIA® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates. MF59® is a registered trademark of Seqirus UK Limited or its affiliates. REFERENCES 1 Centers for Disease Control and Prevention (CDC). Weekly Flu Vaccination Dashboard. Retrieved from: , Accessed June 2023. 2 CDC. 2022-2023 Preliminary In-Season Burden Estimate. Retrieved from: . Accessed June 2023. 3 CDC. Who Needs a Flu Vaccine and When. Retrieved from: . Accessed June 2023. 4 Zhang, Y., Yakob, L., Bonsall, M.B. et al. Predicting seasonal influenza epidemics using cross-hemisphere influenza surveillance data and local internet query data. Sci Rep 9, 3262 (2019). . 5 Australian Government Department of Health and Aged Care. AISR fortnightly report No. 5 – 29 May to 11 June 2023. Retrieved from: . Accessed June 2023. 6 FLUCELVAX® QUADRIVALENT (Influenza Vaccine) [package insert]. Holly Springs, NC: CSL Seqirus Inc, 2023. 7 Rajaram S, Boikos C, Gelone DK, Gandhi A. Influenza vaccines: the potential benefits of cell-culture isolation and manufacturing. Ther Adv Vaccines Immunother. 2020;8:2515135520908121. doi: 10.1177/2515135520908121. 8 CDC. Cell-based flu vaccines. Retrieved from . Accessed June 2023. 9 Rockman S, Laurie K, Ong C, Rajaram S, McGovern I, Tran V, Youhanna J. Cell-Based Manufacturing Technology Increases Antigenic Match of Influenza Vaccine and Results in Improved Effectiveness. Vaccines. 2023; 11(1):52. . 10 McLean HQ, Petrie JG, Hanson KE, et al. Interim Estimates of 2022–23 Seasonal Influenza Vaccine Effectiveness — Wisconsin, October 2022–February 2023. MMWR Morb Mortal Wkly Rep 2023;72:201–205. 11 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: CSL Seqirus Inc, 2023. National 12 Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022–23 Influenza Season. MMWR Recomm Rep 2022;71(No. RR-1):1–28. . 13 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034. 14 O'Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines: 2013;12(1): 13-3. 15 AFLURIA® QUADRIVALENT [package insert]. Parkville, AU: CSL Seqirus Inc, 2023. 16 CDC. People at Higher Risk of Flu Complications. . Accessed June 2023. 17 CDC. Key Facts about Influenza. Retrieved from . Accessed June 2023. SOURCE CSL Seqirus

VaccineClinical ResultDrug Approval

11 Jul 2022

·www.prnewswire.com

Seqirus Begins Shipping Portfolio of Innovative Influenza Vaccines for the 2022/23 U.S. Season

This year marks the first full season that Seqirus' portfolio of innovative influenza vaccines provides a differentiated vaccine option for people of all ages who are eligible in the U.S. to receive a flu shot Seqirus will offer FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine, which is now available for eligible persons six months of age and older 1 Seqirus will offer FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), which is now preferentially recommended by the CDC's Advisory Committee for Immunization Practices as one of the preferred vaccine options for adults 65 years and older, over standard dose influenza vaccines2 SUMMIT, N.J., July 11, 2022 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that it has begun to ship its portfolio of innovative cell-based, adjuvanted and egg-based seasonal influenza vaccines across the U.S. in preparation for the 2022/23 influenza season. The company is prepared to supply more than 55 million doses of influenza vaccines for healthcare providers across the U.S. Seqirus provides a differentiated portfolio of seasonal influenza vaccines that offer protection for people of all ages who are eligible to be vaccinated in the U.S. The portfolio for the 2022/23 U.S. influenza season includes: FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based, quadrivalent influenza vaccine, which for the first full season is now available for individuals six months of age and older.1 FLUCELVAX QUADRIVALENT is a cell-based influenza vaccine, designed to produce an exact match to WHO-selected influenza virus strains.3 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), the first and only adjuvanted quadrivalent seasonal influenza vaccine for adults 65 and older, which is now preferentially recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) over standard dose influenza vaccines.2,4 FLUAD QUADRIVALENT is specifically created for adults 65 years and older using Seqirus' MF59® adjuvant, designed to help strengthen, broaden and lengthen the immune response to influenza vaccination.4,5,6,7 AFLURIA® QUADRIVALENT (Influenza Vaccine), an egg-based, quadrivalent influenza vaccine approved for use in eligible persons six months of age and older.8 "This season, Seqirus' portfolio of influenza vaccines is poised to provide protection to more people than ever before, including vulnerable populations like young children and adults 65 years and older," said Dave Ross, Vice President, North America Commercial Operations, Seqirus. "We look forward to continuing our work with public health partners, who rely on us season after season to deliver safe and effective flu vaccines in order to vaccinate as many people as possible to reduce the risk of flu-related illness and complications." According to the CDC, influenza caused up to 52,000 deaths and 710,000 hospitalizations annually between 2010-2020 in the U.S.9 The CDC continues to recommend vaccination as a critical tool to help protect against influenza by preventing disease and lessoning the severity of disease.10 "While influenza rates have been low since the beginning of the COVID-19 pandemic, relaxed COVID-19 mitigation measures coupled with the return to usual activities could increase the likelihood of a flu resurgence such as what we are seeing already in the Southern Hemisphere," said Dr. Gregg Sylvester, Chief Health Officer, Seqirus.11,12 "With Seqirus' rich history and exclusive focus on influenza, we know that influenza vaccination can save lives and is an important step we can take to help protect ourselves, our loved ones and our communities." About Seasonal Influenza Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.13 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.13 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.13 Estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2019/20 influenza season, there were an estimated 405,000 influenza-related hospitalizations in the U.S.14 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.10 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.10 The CDC recommends that people get vaccinated by the end of October.10 About Seqirus Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. About CSL CSL (ASX:CSL; USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our two businesses, CSL Behring and Seqirus – provides lifesaving products to patients in more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.  For more information visit and . Intended Audience This press release is issued from Seqirus USA Inc. in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products. Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. USA-CRP-22-0030 MEDIA CONTACT Maria Tortoreto +1 (201) 248-5208 [email protected] FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), AFLURIA® QUADRIVALENT (Influenza Vaccine), and FLUCELVAX ® QUADRIVALENT (Influenza Vaccine) IMPORTANT SAFETY INFORMATION for HCPs INDICATIONS AND USAGE FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT. AFLURIA® QUADRIVALENT (Influenza Vaccine) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older. FLUCELVAX® QUADRIVALENT (Influenza Vaccine) is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Do not administer FLUAD QUADRIVALENT or AFLURIA QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine. WARNINGS AND PRECAUTIONS If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT or FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD QUADRIVALENT and FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Ensure procedures are in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position. The immune response to FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. Vaccination with FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT or FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease. ADVERSE REACTIONS FLUAD QUADRIVALENT: The most common (≥ 10%) local and systemic reactions with FLUAD QUADRIVALENT in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%). AFLURIA QUADRIVALENT: AFLURIA QUADRIVALENT administered by needle and syringe: In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (≥ 40%). The most common systemic adverse events were myalgia and headache (≥ 20%). In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥ 20%). The most common systemic adverse event was myalgia (≥ 10%). In children 5 through 8 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse event was headache (≥ 10%). In children 9 through 17 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥ 10%). In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%). The most common systemic adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%). In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%). The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions: In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions with AFLURIA (trivalent formulation) when administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse events were myalgia, malaise (≥ 30%), and headache (≥ 20%). FLUCELVAX QUADRIVALENT: In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (27.9%), erythema (25.8%), induration (17.3%) and ecchymosis (10.7%). The most common systemic adverse reactions were irritability (27.9%), sleepiness (26.9%), diarrhea (17.9%) and change of eating habits (17.4%). In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse reactions were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%). In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse reactions were headache (18.1%) and fatigue (17.0%). In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (45.4%), erythema (13.4%) and induration (11.6%). The most common systemic adverse reactions were headache (18.7%), fatigue (17.8%) and myalgia (15.4%). In adults ≥65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (21.6%) and erythema (11.9%). To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or . Before administration, please see the full US Prescribing Information for FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT. FLUAD ® QUADRIVALENT, AFLURIA ® QUADRIVALENT and FLUCELVAX ® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates. PharmaJet ® and STRATIS ® are registered trademarks of PharmaJet. SOURCE Seqirus

VaccineAntibodyAccelerated Approval

100 Deals associated with Inactivated quadrivalent influenza vaccine (Seqirus GmbH)

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KEGG	Wiki	ATC	Drug Bank
-	-	J07BB01	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza A virus infection	United States	Seqirus Pty Ltd.	28 Sep 2007
Influenza B virus infection	United States	Seqirus Pty Ltd.	28 Sep 2007
Influenza, Human	Denmark	Scandinavian Regulatory Services AB	30 Dec 1997
Influenza, Human	Finland	Scandinavian Regulatory Services AB	30 Dec 1997
Influenza, Human	Netherlands	Scandinavian Regulatory Services AB	30 Dec 1997
Influenza, Human	Sweden	Scandinavian Regulatory Services AB	30 Dec 1997

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02255409 (CTgov)	Phase 3	Influenza, Human	607	Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)	ssmlminqvk = gymdvqkako chqkxydxwv (qkyjbgbyab, sxuzxfmnfw - yaspefnjpz) View more	-	15 Mar 2023
NCT02914275 (CTgov)	Phase 3	Influenza, Human	2,250	Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort A)	iyqdotorqo(ncjdqoqolo) = utjmaeshtd uefbuskklp (jvwcnqrazn, xkunyvgirj - hvrxzntqnl) View more	-	23 Jan 2019
				Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort B)	iyqdotorqo(ncjdqoqolo) = ptdjacqmxg uefbuskklp (jvwcnqrazn, pewhjjonmi - uljvbeeeny) View more
NCT01857297 (CTgov)	Phase 4	Influenza, Human	120	CSL Influenza Vaccine (Adults (18 to 59 Years))	dfwdlkrwub = agwnmdrphk clyjuwusbc (rpyngfcgqz, wnopcehsvi - bnhseyjupg) View more	-	15 Jan 2014
				CSL Influenza Vaccine (Older Adults (60 Years or Older))	dfwdlkrwub = wptvgstoxp clyjuwusbc (rpyngfcgqz, xsshvcthru - rxxxbxswmn) View more
NCT01591837 (CTgov)	Phase 4	Influenza, Human	120	CSL Influenza Vaccine (Adults)	iqmkfowzmp = zsnstauwwq kkwmgtfbrs (sdvylkqeis, cxjcbpfptg - idfmekjgre) View more	-	18 Nov 2013
				CSL Influenza Vaccine (Older Adults)	iqmkfowzmp = ikuyubqwyq kkwmgtfbrs (sdvylkqeis, eykbzwfaaa - qduohkracs) View more
NCT01113580 (CTgov)	Phase 4	Influenza, Human	120	Enzira® Vaccine (Adults)	oxkimlheft = streuaxzpo zhohhkuvdk (ztpytmvnui, plbdibyfml - zoztcwgazs) View more	-	18 Jul 2012
				Enzira® Vaccine (Older Adults)	oxkimlheft = izfauylrxp zhohhkuvdk (ztpytmvnui, zdtuegfxmf - idiayxobai) View more
NCT00735475 (CTgov)	Phase 4	Influenza, Human	1,268	Afluria (Afluria® Group)	qfjktojhyb(txcicfdjqn) = obvhfvfdnn dcuosphlzy (dkgadjjygr, xginfbuwcg - zxhhqgedsj) View more	-	01 Sep 2011
				Fluzone (Fluzone® Group)	qfjktojhyb(txcicfdjqn) = amanmpyegy dcuosphlzy (dkgadjjygr, ojgrhkurne - bmfalxeatk) View more
NCT00959049 (CTgov)	Phase 3	Influenza, Human	1,474	CSL's Influenza Virus Vaccine (Afluria) (Afluria Cohort A)	tbllsjcgxa(tnowiyyuuc) = dkhtqzpvhw abymymiyzx (pjzjnzozvc, xrpxxpaaww - plxwbxbdrv) View more	-	29 Jul 2011
				Influenza Virus Vaccine (Fluzone) (Fluzone Cohort A)	tbllsjcgxa(tnowiyyuuc) = ejwkrkjfdw abymymiyzx (pjzjnzozvc, pxgslexfmi - vpbfkmjhkr) View more

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