Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine Compared With Egg-Based Standard-Dose Quadrivalent Influenza Vaccine in Children 3 to 8 Years of Age.

The purpose of this study was to demonstrate the non-inferior HAI immune response of quadrivalent recombinant influenza vaccine (RIV4) vs licensed Egg-Based Quadrivalent Influenza Vaccine (IIV4) for the 4 strains based on the egg-derived antigen in all participants aged 3 to 8 years and to describe the immunogenicity and safety profile of RIV4 compared to IIV4 in participants aged 3 to 8 years.

Start Date10 Nov 2022

Sponsor / Collaborator

Sanofi Pasteur SA

NCT05409612

/ CompletedPhase 3IIT

Multicenter, Randomized, Open, Phase III, Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients

Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects.
Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.

Start Date07 Nov 2022

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

[+2]

NCT05513053

/ CompletedPhase 3

Immunogenicity and Safety of Quadrivalent Recombinant Influenza Vaccine (RIV4) in Children and Adolescents Aged 9 to 17 Years and Adults Aged 18 to 49 Years.

The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.

Start Date27 Oct 2022

Sponsor / Collaborator

Sanofi Pasteur SA

100 Clinical Results associated with Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

100 Translational Medicine associated with Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

100 Patents (Medical) associated with Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

Literatures (Medical) associated with Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

01 Oct 2025·LANCET INFECTIOUS DISEASES

Comparative assessment of immunogenicity and safety of recombinant influenza vaccine in children, adolescents, and adults: results from a phase 3, immunobridging, open-label, non-randomised study

Article

Author: See, Stephanie ; De Bruijn, Iris ; Kaas-Leach, Kathleen ; Tabar, Cynthia ; Pepin, Stephanie ; Konieczny, Marek ; Folegatti, Pedro M ; Drazan, Daniel ; Essink, Brandon ; Natalini Martínez, Silvina ; Talanova, Oxana ; Bertoch, Todd ; Fries, Katherine

BACKGROUND:

The recombinant influenza vaccine (RIV) is licensed for adults older than 18 years but is not approved for paediatric groups. This study aimed to demonstrate the non-inferior immune responses and safety of RIV in participants aged 9-17 years compared with adults aged 18-49 years.

METHODS:

This was a phase 3, non-randomised, immunobridging, open-label, uncontrolled study conducted at 36 centres in Europe and the USA during the 2022-23 northern hemisphere influenza season. The main exclusion criteria were receipt of an influenza vaccine up to 6 months before enrolment and receipt of any other vaccines within 4 weeks before or after study intervention (except for COVID-19 vaccination, which was allowed at least 2 weeks before or after enrolment). Healthy participants aged 9-49 years received a single dose of quadrivalent RIV and were followed up for 6 months on days 9, 29, and 181. Haemagglutination inhibition (HAI) assays to assess immunogenicity were used to test blood samples obtained at baseline and day 29. The primary outcome was the non-inferiority of immune response at day 29 as assessed by HAI titre ratios and differences in seroconversion rates between the two age groups. The non-inferiority of a geometric mean titre was demonstrated if the lower limit of the two-sided 95% CI of the geometric mean titre (GMT) ratio was above 0·667 for each of the four strains of virus. Similarly, the non-inferiority of seroconversion was demonstrated if the lower limit of the two-sided 95% CI was -10% or above for each of four strains. Safety was monitored throughout the study. This study was registered at ClinicalTrials.gov (NCT05513053) and is complete.

FINDINGS:

Between Oct 27, 2022, and May 1, 2023, a total of 1308 participants were enrolled, all of whom attended the first study visit. 1299 participants (99%) received the study vaccine (641 participants [49%] in the age 9-17 years group and 658 participants [51%] in the age 18-49 years group). The mean age of participants in the age 9-17 years group was 13·0 years (SD 2·5) and was 34·3 years (9·2) in the age 18-49 years group. Overall, 707 participants (54%) were female and 601 participants (46%) were male. Most of the participants were White (1003 [77%] of 1308); the next largest category was Black or African American (255 [19%]); 149 (11%) participants identified as Hispanic or Latino. The HAI GMT ratio between the paediatric and adult groups at day 29 in the per-protocol analysis set was 2·0 (95% CI 1·7 to 2·3), 3·3 (2·8 to 3·9), 1·6 (1·4 to 1·8), and 1·2 (1·1 to 1·4) for A/H1N1, H3N2, B/Victoria, and B/Yamagata, respectively. Differences in seroconversion between the groups were 1·9 (-2·8 to 6·6), -0·6 (-4·4 to 3·2), 3·3 (-1·6 to 8·1), and 14·3 (9·2 to 19·3) for each of the four strains, respectively. The safety profile was comparable in both age groups, except for solicited reactions within 7 days post-vaccination that were fewer in children and adolescents (274 [44%] of 618; 95% CI 40 to 48) than in adults (336 [53%] of 635; 49 to 57). No related serious adverse events, deaths, or adverse events of special interest were reported.

INTERPRETATION:

RIV4 induced non-inferior immune responses in the participants aged 9-17 years compared with those aged 18-49 years. No safety concerns were reported.

FUNDING:

Sanofi.

01 Aug 2025·VACCINE

Immunogenicity and safety of quadrivalent recombinant influenza vaccine in Korean adults: Phase III, randomized study

Article

Author: Choe, Sunho ; Peng, Lin ; Choi, Won Suk ; Lee, Jacob ; Samson, Sandrine ; Shin, Sooyoun ; Kim, Woo Joo ; Ottaviano, Cecilia

Quadrivalent recombinant influenza vaccine (RIV4) is indicated for active immunization against influenza virus in adults (≥18 years) in countries where it is currently registered. This Phase III, parallel, randomized, modified double-blind, active controlled, multi-center study was designed to compare the immunogenicity and safety of single dose intramuscular RIV4 with a locally-licensed quadrivalent-inactivated influenza vaccine (IIV4, Fluarix® quadrivalent) in participants aged ≥18 years during 2021-22 Northern Hemisphere influenza season at three tertiary care centers in South Korea. Participants were randomized (1:1) to receive single dose intramuscular RIV4 or IIV4. All participants were centrally assigned to randomized study intervention using an interactive response technology (IRT). Participants, investigators, and the staff in-charge of the sampling, safety assessment and immunogenicity assays were blinded. The overall mean age of 300 participants who completed the study was 46.1 years. The post-vaccination geometric mean fold-rise of HAI antibodies were 32.0, 13.2, 6.1, and 5.3 in RIV4 group, and 22.3, 8.0, 4.7, and 3.4 in IIV4 group for the A/H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage strains, respectively. Seroconversion in RIV4 was comparable or higher than IIV4. Neither immediate unsolicited AEs were reported within 30 min of vaccination nor SAEs, AESIs nor deaths were reported during the 6-month follow-up. Clinical Trial Registration:ClinicalTrials.gov number - NCT05144945.

01 Aug 2025·AJOG global reports

Corrigendum to ‘Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants’ [AJOG Global Reports Volume 4, Issue 4, November 2024, 100395]

Author: Talanova, Oxana ; Izikson, Ruvim ; Gandhi-Banga, Sonja ; Yee, Arnold ; Hsiao, Amber ; Lewis, Ned ; Klein, Nicola P ; Inamdar, Ajinkya ; Kabler, Heidi ; Fireman, Bruce ; Hansen, John ; Selmani, Alexandre

[This corrects the article DOI: 10.1016/j.xagr.2024.100395.].

News (Medical) associated with Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

14 Oct 2025

·www.einpresswire.com

2025 Biological License Application Supplement Noteworthy Approvals

Whole Blood and Blood Components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived) Treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment. 125396/21 Stanford Blood Center 3373 Hillview Avenue Palo Alto, CA 94304 10/10/2025 VYJUVEK beremagene geperpavec-svdt Expand the indication to treat wounds in adults and pediatric patients (0 to 16 years of age) with dystrophic epidermolysis bullosa, and to allow application of VYJUVEK in home setting by a healthcare professional, patient or caregiver. 125774/89 Krystal Biotech, Inc. 2100 Wharton Street Suite 701 Pittsburgh, PA 15203 Lic. # 2301 9/12/2025 VONVENDI von Willebrand Factor (Recombinant) To expand the current approved adult prophylaxis indication for type 3 von Willebrand disease (VWD) to include adults with type 1 and type 2 VWD and to expand the use to pediatric patients with VWD for on demand treatment and control of bleeding episodes and perioperative management of bleeding. 125577/691 Takeda Pharmaceuticals USA, Inc 500 Kendall Street Cambridge, MA 02142 Lic. # 1898 9/5/2025 NUVAXOVID COVID-19 Vaccine, Adjuvanted To include the 2025-2026 Formula and associated labeling revisions. 125817/6 Novavax, Inc. 700 Quince Orchard Road Gaithersburg, MD 20878 Lic. # 2349 8/27/2025 MNEXSPIKE COVID-19 Vaccine, mRNA To include the 2025-2026 Formula and associated labeling revisions for use in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. 125835/6 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 8/27/2025 SPIKEVAX COVID-19 Vaccine, mRNA To include the 2025-2026 Formula and associated labeling revisions. 125752/305 Moderna TX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 8/27/2025 COMIRNATY COVID-19 Vaccine, mRNA To include: 10 mcg drug product (2025-2026 Formula) in the single-dose vial presentation manufactured at the Pfizer, Puurs facility and associated labeling revisions, for use in individuals 5 years through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19; and 30 mcg drug product (2025-2026 Formula) in the single-dose prefilled syringe presentation manufactured at the Pfizer, Puurs facility and associated labeling revisions, for use in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. 125742/656 BioNTech Manufacturing GmbH Pfizer, Inc. 66 Hudson Boulevard East New York, NY 10001 Lic. # 2229 8/27/2025 AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted To include data on the safety and efficacy of AREXVY against Respiratory Syncytial Virus (RSV) associated lower respiratory tract disease in individuals 60 years of age and older over three RSV seasons following administration of a single dose. 125775/297 GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 8/8/2025 CAPVAXIVE Pneumococcal 21-valent Conjugate Vaccine To update Section 8 "Use in Specific Populations", Section 6 “Clinical Trials Experience”, and Section 14 “Clinical Studies” of the package insert for the inclusion of individuals living with HIV (V116-007) and individuals at increased risk of pneumococcal disease (V116-008). 125814/149 Merck Sharp & Dohme LLC P.O. Box 1000 UG2D-68 North Wales, PA 19454-2505 Lic. # 0002 7/31/2025 Imovax Rabies Rabies Vaccine To update the package insert to include a 2-dose pre-exposure prophylaxis dosing regimen in addition to the currently approved 3-dose regimen. 103931/5342 Sanofi Pasteur SA Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1724 7/24/2025 SPIKEVAX COVID-19 Vaccine To prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and to include a new 0.25 mL pre-filled syringe presentation. 125752/276 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 7/9/2025 GAMMAGARD LIQUID ERC Immune globulin infusion (human) 10% solution For the indication of a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. 125105/2184 Takeda Pharmaceuticals U.S.A., Inc. 650 E. Kendall Street Cambridge, MA 02142 Lic. # 1898 6/27/2025 MRESVIA Respiratory Syncytial Virus Vaccine To revise the indication and usage to include active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. 125796/37 ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 6/12/2025 ABRYSVO Respiratory Syncytial Virus Vaccine To update the Package Insert to include safety and efficacy data from two full Respiratory Syncytial Virus (RSV) seasons from the Phase 3 clinical study C3671013, and the final safety data from the Phase 3 study C3671008. 125769/277 Pfizer Inc. 500 Arcola Road Collegeville, PA 19426 Lic. # 2001 6/9/2025 MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine To update the Package Insert to include safety and effectiveness data from postmarketing requirement (PMR) studies MET41, MET42 and MET61 that support lowering the age for use to include individuals 6 weeks through 23 months of age. 125701/262 Sanofi Pasteur, Inc. Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1725 5/23/2025 AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted To update the Package Insert to include data from two clinical studies of concomitant administration of AREXVY with influenza vaccines in individuals 65 years of age and older. 125775/247 GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. # 1617 5/23/2025 Jivi Antihemophilic Factor (recombinant), PEGylated-aucl To revise the indication to include pediatric patients 7 to <12 years of age. 125661/972 Bayer HealthCare LLC 100 Bayer Boulevard, P.O. Box 915 Whippany, NJ 07981-0915 Lic. # 0008 5/14/2025 FluBlok Influenza Vaccine To update the product labeling to include data and results from PREA PMR studies VAP00026 (3-8 year olds) and VAP00027 (9-17 and 18-49 year olds), and to use data from VAP00027 to support extending the Flublok indication to individuals 9 through 17 years of age, and to fulfill (PREA) PMR #1 and (PREA) PMR #2 (125285/471). 125285/613 Protein Sciences Corporation Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 Lic. #1795 03/31/2025 JYNNEOS Smallpox and Mpox Vaccine, Live, Non-replicating To include a two-vial presentation of JYNNEOS that consists of a Lyophilized Antigen Component vial and a Diluent Component vial. 125678/119 Bavarian Nordic A/S Bavarian Nordic Inc. 1005 Slater Road, Suite 101 Durham, NC 27703 Lic. #2096 03/31/2025 SHINGRIX Zoster Vaccine Recombinant, Adjuvanted To update the US Prescribing Information to include information from Study Zoster-049 on long term effectiveness of SHINGRIX. 125614/1022 GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. #1617 03/21/2025 ODACTRA House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract To include use in children 5 through 11 years of age. 125592/218 ALK-Abello A/S ALK-Abello Inc. 135 Route 202/206 Suite 16 Bedminster, NJ 07921 Lic. #1292 02/27/2025 Anti-Human Globulin To replace the Anti-C3d used in MTS Anti-IgG, -C3d gel cards manufactured in Pompano Beach, Florida facility. 103461/5123 Micro Typing Systems, Inc. 100 Indigo Creek Drive Rochester, NY 14626 Lic. #1177 01/28/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

VaccinePhase 3Drug ApprovalImmunotherapyClinical Result

10 Oct 2025

·www.pharmaceutical-technology.com

Flu vaccine uptake increases 28% in England

There are currently seven licensed flu vaccines available for the 2025 to 2026 season. Tong_stocker via Shutterstock.com. The number of people receiving a flu vaccine across England has increased by over a quarter, as cases of both influenza and Covid-19 start to climb at the start of the viral season. Data from England’s National Health Service (NHS) shows that the flu jab has been administered to 4.3 million people, a 28% rise from 3.36 million who received the vaccine at the same point last year. The vaccination drive comes as the flu season commences. Influenza infections start to uptick around October, with peaks usually coming in December. Vaccines can help protect against the flu and are offered to people every year at higher risk of becoming seriously ill. Caused by the influenza virus, flu is significantly more serious than the common cold, which is caused by a wide range of viruses. The UK Health Security Agency’s (UKHSA’s) latest surveillance data showed that flu positivity increased from 1.9% to 3.3% and Covid-19 positivity in hospital settings increased from 11.7% in the previous week to 12.9%. One of the key changes to this year’s vaccine programme is the switch from quadrivalent (QIV) to trivalent (TIV) vaccines in inactivated influenza vaccines (IIV). The World Health Organization (WHO) recommends the composition of influenza vaccine strains each year based on global virus trends. For the 2025/26 season, WHO recommends the use of the trivalent vaccine for the Northern Hemisphere. This is because the influenza B/Yamagata lineage virus has not been detected worldwide since 2020 and is not predicted to cause future epidemics. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence There are currently seven licensed flu vaccines available for the 2025 to 2026 season. CSL Seqirus’ cell-based quadrivalent influenza vaccine, Sanofi’s Vaxigrip, and Viatris’ Influenza vaccine TIV MYL are given to those above six months of age. AstraZeneca’s Fluenz Tetra, a live attenuated influenza vaccine (LAIV), is for those between two and 18 years of age. For adults over 18 years of age, Sanofi’s Supemtek, a recombinant trivalent influenza vaccine, is used. CSL Seqirus’ other adjuvanted trivalent influenza vaccine is licensed for use for adults above 50 years of age. Sanofi’s Efluelda TIV-HD is available to those 60 years of age and over. The NHS offers flu vaccines for everyone aged 65 and over, and for adults 18 to 64 years of age in certain risk groups. The NHS is bracing itself for a busy winter. Regional teams are improving access to the vaccines through mobile vaccination buses, family community drop-in sessions, and, in an NHS first, delivering flu vaccines to two and three-year-olds in community pharmacies. Meanwhile, eligibility for the Covid-19 vaccine changed for this autumn and winter following an update on recommendations by the Joint Committee on Vaccination and Immunisation (JCVI). The committee advises that the vaccines be offered to people aged 75 or over, residents in care homes, or anyone with a weakened immune system. Dr Amanda Doyle, national director for Primary Care and Community Services at NHS England, said : “Vaccination is a crucial part of our efforts to protect the vulnerable and prepare for what we expect to be a very challenging winter, so I’m delighted to see this big increase in the numbers of people getting vaccinated at this stage. “Vaccinations are our best defence against these potentially very dangerous viruses and can genuinely save lives.” Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

VaccineDrug Approval

10 Jul 2024

·www.pharmaindustrial-india.com

Sanofi Starts Shipping US Influenza Vaccines for 2024-25

Sanofi has begun shipped its first influenza (flu) vaccines across the U.S. in preparation for the 2024–25 flu season. Following this first shipment, additional shipments of the full Sanofi flu vaccine portfolio will continue through October to healthcare provider offices, pharmacies and other immunizers to support fall immunization campaigns. With over 125 years of heritage in helping protect global public health, Sanofi is a world leader in vaccines, helping to vaccinate more than 500 million people annually. Thomas Grenier, Head of Vaccines, North America, Sanofi said, "Today, we began shipping flu vaccines for the upcoming season, a moment that underscores our long-standing commitment to providing global protection against disease. Getting a flu shot is imperative to not only help protect against flu infection, but also to help reduce the risks of its potentially severe complications, which can lead to hospitalizations, especially in those most vulnerable. Sanofi understands what these populations need out of their flu shots and works tirelessly from start to finish to provide proven and specific solutions." All flu vaccines provided by Sanofi to the US market are trivalent, meaning they offer protection against the current three strains of influenza (two influenza A strains and one influenza B strain). These strains were selected based on a collaborative review of influenza surveillance by the US Food and Drug Administration (FDA), World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), among other public health experts, as the strains most likely to cause illness in the upcoming flu season. Annual flu vaccination is one of the best ways to help protect against flu and its complications. Public health authorities worldwide reiterate their recommendations for eligible people to be vaccinated every year. As one of the largest providers of influenza vaccines to the United States with a range of options, Sanofi meets immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older. This year's 2024/25 US influenza season portfolio includes Fluzone High-Dose (Influenza Vaccine), Flublok (Influenza Vaccine) and Fluzone (Influenza Vaccine). Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for the prevention of disease caused by influenza A and B strains contained in the vaccine. Fluzone is given to people 6 months of age and older. Flublok is given to people 18 years of age and older. Fluzone High-Dose is given to people 65 years of age and older. Fluzone, Flublok, or Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including eggs or egg products for Fluzone and Fluzone High-Dose). In addition, Fluzone and Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction after a previous dose of any influenza vaccine.

Vaccine

100 Deals associated with Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza, Human	European Union	Sanofi Winthrop Industrie SA	16 Nov 2020
Influenza, Human	Iceland	Sanofi Winthrop Industrie SA	16 Nov 2020
Influenza, Human	Liechtenstein	Sanofi Winthrop Industrie SA	16 Nov 2020
Influenza, Human	Norway	Sanofi Winthrop Industrie SA	16 Nov 2020
Influenza A virus infection	United States	Protein Sciences Corp.	16 Jan 2013
Influenza B virus infection	United States	Protein Sciences Corp.	16 Jan 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Vaccination	Phase 3	United States	Sanofi Pasteur SA	27 Oct 2022
Vaccination	Phase 3	Czechia	Sanofi Pasteur SA	27 Oct 2022
Vaccination	Phase 3	Poland	Sanofi Pasteur SA	27 Oct 2022
Vaccination	Phase 3	Spain	Sanofi Pasteur SA	27 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05144945 (Pubmed \| Vaccine)	Phase 3	Influenza, Human	300	Quadrivalent recombinant influenza vaccine (RIV4)	mtejdpvhsh(vnqmugwofp) = Neither immediate unsolicited AEs were reported within 30 min of vaccination nor SAEs, AESIs nor deaths were reported during the 6-month follow-up. ghtowbsbwx (lakcmxfgdo ) View more	Positive	01 Aug 2025
				Fluarix quadrivalent
NCT05514002 (Pubmed \| Open Forum Infect Dis)	Phase 4	Influenza, Human	3,988	Recombinant Influenza Vaccine (RIV)	jvqjriuvzl(xlcpplnltf) = qsbuabhhtm oebveyckud (jlizhcsnlq )	Positive	27 Sep 2024
				Standard-Dose Inactivated Influenza Vaccine (SD IIV)	jvqjriuvzl(xlcpplnltf) = epyvkxbmkr oebveyckud (jlizhcsnlq )
NCT05513391 (CTgov)	Phase 3	Vaccination \| Influenza, Human	366	RIV4 (RIV4)	zamlzsxzsk(lwynnfylzd) = mqrkffxytd hbgybsshad (npxlqyskip, ggxhiqjuui - hlhkkoharo) View more	-	24 Jul 2024
				IIV4 (IIV4)	zamlzsxzsk(lwynnfylzd) = jfmpojgbam hbgybsshad (npxlqyskip, uxyjvbnycc - vuwumfqokw) View more
NCT03722589 (CTgov)	Phase 4	Influenza, Human	944	Flublok (Flublok (Recombinant))	pwqkixnuxl = pwdqbpviad knwbguzsft (yhuxozrnnc, mesxxssobs - koayfpaila) View more	-	22 Jul 2024
				Flucelvax (Flucelvax (Cell-based))	pwqkixnuxl = ijwxngxsck knwbguzsft (yhuxozrnnc, xohhlhcrqf - weicfryhng) View more
NCT04523324 (CTgov)	Phase 4	Influenza A virus infection \| Influenza, Human	577	Flublok™ Quadrivalent by Sanofi, Inc. (RIV4 (Flublok Quadrivalent))	bkiaortpkj(grghlkxapp) = lpryakockb vkhsapahlh (bjfihlvcga, rwlmprhhbi - ksywchlmfx) View more	-	15 Nov 2023
				VaxigripTetra™ by Sanofi, Inc. (IIV4 (Vaxigrip Quadrivalent))	bkiaortpkj(grghlkxapp) = zisbgwpyvd vkhsapahlh (bjfihlvcga, zvpamulbor - lumuvmiadk) View more
NCT05144945 (CTgov)	Phase 3	Influenza, Human	301	Quadrivalent Recombinant Influenza Vaccine (RIV4) (Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4))	vrmibmxapy(ikknndplna) = yptkwruytf bpudottsrm (dcdkstlfwc, kuglyuxoqu - zsmnpaykty) View more	-	29 Sep 2023
				Quadrivalent inactivated influenza vaccine (Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4))	vrmibmxapy(ikknndplna) = nqcpuzedxw bpudottsrm (dcdkstlfwc, teknpjbnlj - fcqnjbpuht) View more
NCT03658629 (CTgov)	Phase 2	Influenza, Human	1,375	Placebo+Quad-NIV-1+NanoFlu (Quad-NIV) (Quad-NIV Bedside Mix of Antigen and Adjuvant Dose A)	ahgihbzzps = novndwacfq cvwdezkxdn (bhlcllgdzr, zyminwynsw - nkdvolzkjy) View more	-	04 Nov 2022
				Quad-NIV (Quad-NIV Preformulated With Adjuvant Dose A)	ahgihbzzps = patzuuqzsv cvwdezkxdn (bhlcllgdzr, kvbsyxwetv - okblrhsqgk) View more
NCT03617523 (GRC90, CTgov)	Phase 4	Influenza, Human	240	Fluzone Quadrivalent vaccine (Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months)	iqbxuiepkv = slweamrffe touqgnutye (vlkovdyfxu, dkfgvrkito - wayddmwgeh) View more	-	25 Nov 2019
				Fluzone Quadrivalent vaccine (Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years)	jcnpiqptzw = pzgmkvfjbx kppisuksko (jxmpomhtny, kftbslhxrr - zlhwpjsfqz) View more
NCT02285998 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Influenza, Human	9,003	recombinant influenza vaccine (RIV4)	ovstmmtpqv(unrhehgoal) = lszlxbhoji yglczlbfko (utmvtnutjz ) View more	Positive	22 Jun 2017
				quadrivalent, inactivated influenza vaccine (IIV4)	ovstmmtpqv(unrhehgoal) = xgchutrzbt yglczlbfko (utmvtnutjz ) View more
NCT02285998 (CTgov)	Phase 3	Influenza, Human	9,003	Flublok Quadrivalent Influenza Vaccine (Flublok Quadrivalent Influenza Vaccine)	oygzwtnzaq = sxsuifmjaj ckowemtool (bpzatfqwta, iegvgmandx - hfyzcogpja) View more	-	04 Oct 2016
				Inactivated Influenza Vaccine (Inactivated Influenza Vaccine)	oygzwtnzaq = fqchgetwfa ckowemtool (bpzatfqwta, cixartfckj - qwcknhokbh) View more

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Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

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