A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 Concomitantly Administered With Seasonal Influenza Vaccine in Healthy Subjects 50 Years of Age and Older

This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.

Start Date12 Jan 2026

Sponsor / Collaborator

Vaxcyte, Inc.

NCT07240922

/ RecruitingPhase 4IIT

The Dynamics of the Immune Responses to Repeat Influenza Vaccination Exposures (DRIVE III) Study - a Randomized Controlled Trial

This study will provide novel insight into the effects of repeat influenza vaccination with Flublok and FluMist on the strength and breadth of immune responses to influenza, the mechanisms underlying heterogeneity in vaccine response and vaccine failure, and biological factors that could explain variation in influenza vaccine effectiveness.

Start Date01 Oct 2025

Sponsor / Collaborator

The University of Hong Kong

NCT06518577

/ CompletedPhase 4IIT

Measuring Immunity Against Circulating Influenza Viruses: Randomized Immunogenicity Study Among US Adults Aged 18-64 Years Comparing Two Approved Influenza Vaccines

This study is a randomized immunogenicity study in an enrolled cohort with active surveillance for influenza-like illness (ILI). During this study, participants will be randomly assigned to receive an approved cell culture-based influenza vaccine (Flucelvax) versus a licensed comparator influenza vaccine (Flublok or Fluzone). Blood samples from participants will be collected for measurement of biomarkers of immune response at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Participants will be asked if they wish to also provide saliva specimens at baseline (visit 1; day 1), post-vaccination (visit 2; day 29), and post-season (visit 3; day 181). Serum and peripheral blood mononuclear cells (PBMC) and plasma samples will be isolated from whole blood and tested for biomarkers of vaccine immunogenicity, and duration of antibody responses.
Participants will receive electronic surveys via email or text message weekly asking about changes in health status and new ILI symptoms; those reporting illness may be asked to provide a respiratory swab for laboratory testing for influenza and other respiratory viruses and up to 2 additional blood draws (acute [<10 days after symptom onset] and convalescent [28 days after acute visit if lab-confirmed positive for influenza]).

Start Date09 Sep 2024

Sponsor / Collaborator

Duke University

[+5]

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 ; Bertoch, Todd ; Talanova, Oxana ; 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.)

30 Jan 2026

·www.fiercepharma.com

CHMP thumbs-up Novo's semaglutide for MASH, as Amgen gets Tavneos re-review on data integrity concerns

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) signed off on six new drugs as well as a clutch of approved drugs that received positive opinions for new indications. In the latest bunch of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk’s semaglutide for severe liver disease could be soon off to the European market under a new name, while Eli Lilly’s Mounjaro didn’t quite make the cut for a new cardiovascular indication and Amgen’s approved Tavneos is up for a second look as concerns emerge on the data integrity of the drug’s pivotal trial.Novo’s Wegovy (semaglutide) made headlines last summer as the second drug in the U.S. approved to treat adult metabolic dysfunction-associated steatohepatitis (MASH) in certain patients. The FDA’s conditional nod made for Wegovy’s third indication, along with obesity and cardiovascular risk reduction, validating Novo’s continued pursuance of the tough-to-treat condition after previous let downs.The CHMP has now agreed with the FDA, recommending a conditional marketing authorization for the med, which will be branded separately from Wegovy in Europe under the name Kayshild. In other GLP-1 decisions, Eli Lilly’s Mounjaro also received news from the CHMP, as the agency has finalized its assessment of Lilly’s bid to extend the drug’s use to cover chronic heart failure with preserved ejection fraction (HFpEF) in adults with obesity.Although the EMA did not ultimately recommend a separate indication for the new use, it agreed to include “relevant data” from the Mounjaro study in this indication in the drug’s label, ensuring “up-to-date data on the effects of Mounjaro in adults with chronic HFpEF and obesity.” The regulator opted against a wholly new indication based on “uncertainty” remaining as to whether the positive results seen in the study is a “weight-loss-independent effect of Mounjaro,” the EMA explained in a release (PDF).Elsewhere, six new medicines, including Kayshild, earned positive CHMP opinions. UCB’s thymidine kinase 2 deficiency (TK2d) drug Kygevvi stood out as a positive opinion issued under “exceptional circumstances,” since the rarity of the disease means that the company had to use a single arm, 39-patient study and a retrospective chart review in its drug application. If approved, the drug would be the first treatment option for the rare genetic disease, and UCB would have to comply with yearly post-marketing obligations.“This positive CHMP opinion marks a turning point in the treatment of TK2d, offering a new chapter of hope and a meaningful step forward for patients, families, and clinicians alike,” UCB’s chief medical officer, Donatello Crocetta, commented in a company release. Sanofi, meanwhile, came out with two wins with a CHMP recommendation for its recombinant, quadrivalent flu vaccine Supemtek and for its Rezurock, which would be a new treatment option for adults and children with chronic graft-versus-host disease (GVHD). Sanofi had requested a re-review of Rezurock after a negative opinion was adopted by CHMP in October. The French pharma is making a commitment to conduct a new post-approval confirmatory study given the “limited late-line treatment options available for EU patients living with chronic GVHD and the body of Rezurock clinical evidence generated,” EVP of Sanofi’s general medicines unit, Olivier Charmeil, explained in a company release.The prior negative opinion was made because it “was difficult to quantify” the effect Rezurock had on patients relative to other treatments, the CHMP said at the time. Rezurock is already approved in 20 countries, including the U.S.Rounding out the wave of positive opinions, the CHMP also signed off on a hormone replacement therapy for menopause called Fylrevy (estetrol) made by Hungarian pharma Gedeon Richter and a radiolabeling product made by Shine that’s called Ilumira.Johnson & Johnson’s Akeega, Neurocrine’s Efmody, ARS’s Eurneffy (sold as Neffy in the U.S.), Incyte’s Inclusig, AstraZeneca’s Imfinzi, Bayer’s Kerendia, Merck’s Noxafil, Bristol Myers Squibb’s Opdivo and Incyte’s Zynyz all are up for label expansions based on positive CHMP opinions.Zynyz in particular would be Europe’s first immunotherapy-based treatment for squamous cell carcinoma of the anal canal (SCAC), the most common type of anal cancer. If approved, the drug could be a “new standard-of-care for patients living with this rare and difficult-to-treat cancer,” head of Incyte International Lee Heeson said in a company statement.All of CHMP’s recommendations are now off to the European Commission for final approval. Tavneos re-reviewTucked in with the positive opinions was negative news for Amgen’s complement inhibitor Tavneos, which CSL Vifor markets in Europe. Amgen took on the drug through its ChemoCentryx buyout in 2022. In January of that year, European regulators signed off on the drug to treat granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), two rare inflammatory blood vessel conditions. The initial approval hinged on results from ChemoCentryx’s Advocate study, which compared Tavneos to high-dose corticosteroids in 331 patients and found that the med was as effective at prompting remission as the corticosteroids. But concerns about the trial have been mounting since 2021, when the FDA flagged several efficacy and safety issues in the study. Although Tavneos eventually got its FDA nod with a narrower label than anticipated, investors with money tied up in the debacle filed a lawsuit in 2022 alleging that the company knew about the FDA’s concerns but downplayed the situation to its shareholders. As the legal feud continued, additional evidence emerged last year pointing to a larger data integrity issue in the trial. Nonetheless, ChemoCentryx emerged victorious in a securities fraud complaint last summer and the FDA hasn’t taken action that would impact its U.S. approval. The EMA, however, will now “review all available data” to assess if the “emerging information” impacts the drug’s risk/benefit profile, the agency said in a Jan. 30 alert. The review was initiated at the request of the European Commission.“The concerns relate to how the company handled the data for the Advocate study before Tavneos was authorised, which may have impacted the findings on the medicine’s effectiveness,” the EMA explained.After the review, the agency will decide if the drug's marketing approval should be kept, suspended, amended or pulled altogether, it said. Despite the years-long legal back-and-forth, Tavenos garnered $256 million in revenue for Amgen during 2024, in 111% growth year over year.

Drug ApprovalAcquisitionClinical ResultAccelerated ApprovalVaccine

30 Jan 2026

·endpoints.news

CHMP opposes Lilly’s Mounjaro in heart failure, backs Novo’s Kayshild for liver disease

EU regulators have refused to greenlight Eli Lilly’s weight loss drug Mounjaro as a treatment for a type of heart failure, while giving the go-ahead for Novo Nordisk’s semaglutide in liver disease. Lilly failed to get support from the European Medicines Agency’s human medicines committee, or CHMP, on Friday for Mounjaro to treat chronic heart failure with preserved ejection fraction in adults with obesity. HFpEF is when the heart becomes too stiff to pump enough blood around the body. The committee said Mounjaro didn’t reduce the number of patient deaths due to heart problems in patients with obesity and HFpEF. While the drug did reduce the number of heart failure-related hospitalizations, it’s unclear whether that was due to the weight loss-independent effect of Mounjaro, CHMP said. Lilly had also been angling after the heart failure label expansion in the US, but withdrew the application for Mounjaro — marketed as Zepbound for weight loss — from the FDA in May. Despite declining to expand Mounjaro’s label for heart failure, the committee said it would include the data from Lilly’s Phase 3 SUMMIT study in the drug’s product information. Meanwhile, Novo Nordisk won the panel’s go-ahead for semaglutide, branded as Kayshild, to be used as a treatment for patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis stages F2 to F3. Semaglutide is already available in the US to treat patients with MASH, after securing FDA approval in August. CHMP also gave positive opinions for four other new therapies: The agency also gave recommendations to extend the labels of nine therapies:

Drug ApprovalPhase 3Accelerated Approval

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

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

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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

Clinical Result

Indication

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Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05144945 (Pubmed \| Vaccine)	Phase 3	Influenza, Human	300	Quadrivalent recombinant influenza vaccine (RIV4)	pqcnqlbmjh(odngawgrjo) = Neither immediate unsolicited AEs were reported within 30 min of vaccination nor SAEs, AESIs nor deaths were reported during the 6-month follow-up. eviingmlng (zhuwzrsnxl ) View more	Positive	01 Aug 2025
				Fluarix quadrivalent
NCT05514002 (Pubmed \| Open Forum Infect Dis)	Phase 4	Influenza, Human	3,988	Recombinant Influenza Vaccine (RIV)	wtaxawxbup(dvmcgsdfya) = uqdzzvbbaz bwuzkbntzh (dpcezbdlok )	Positive	27 Sep 2024
				Standard-Dose Inactivated Influenza Vaccine (SD IIV)	wtaxawxbup(dvmcgsdfya) = vhhecosutm bwuzkbntzh (dpcezbdlok )
NCT05513391 (CTgov)	Phase 3	Influenza, Human	366	RIV4 (RIV4)	pndajygssw(mrqcleebep) = raopdwqwtc atgxcphoxx (fgfvxrsrrz, wkbbblivar - ahnpeozmne) View more	-	24 Jul 2024
				IIV4 (IIV4)	pndajygssw(mrqcleebep) = pnfryabtwg atgxcphoxx (fgfvxrsrrz, suzqcigyht - jctkrbzcuq) View more
NCT03722589 (CTgov)	Phase 4	Influenza, Human	944	Flublok (Flublok (Recombinant))	vjzeokoqgx = fhvoubnkbr lqnkjvnoqr (akbmgptvyv, xlvpnwjyhv - eluglgceml) View more	-	22 Jul 2024
				Flucelvax (Flucelvax (Cell-based))	vjzeokoqgx = ceokuyname lqnkjvnoqr (akbmgptvyv, ylmjkmorfa - ihbtgiziix) View more
NCT05513053 (CTgov)	Phase 3	Influenza, Human	1,308	RIV4 (Cohort 1: Participants Aged 9 to 17 Years)	nlxvvfzprs(debobvjwpv) = utfhvekhor ccxmduvxcd (aiuftdqheq, clzichwenr - qluzkbzqhh) View more	-	30 May 2024
				RIV4 (Cohort 2: Participants Aged 18 to 49 Years)	nlxvvfzprs(debobvjwpv) = yjtztyzyws ccxmduvxcd (aiuftdqheq, sfbcnnffqu - kirnzyagdt) View more
NCT05144945 (CTgov)	Phase 3	Influenza, Human	301	Quadrivalent Recombinant Influenza Vaccine (RIV4) (Group 1: Quadrivalent Recombinant Influenza Vaccine (RIV4))	mxytroyhzq(simtighxqi) = wybhcetzyu ihefjjonff (tadvfvvkmx, fhoxxjgpje - vaiwsqvqpz) View more	-	29 Sep 2023
				Quadrivalent inactivated influenza vaccine (Group 2: Quadrivalent-inactivated Influenza Vaccine (IIV4))	mxytroyhzq(simtighxqi) = ckjmboifos ihefjjonff (tadvfvvkmx, sqpaplzsur - scqpsjvmkk) 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)	myutfexqon = ftpqzqduxc edvxrzoldf (vnzdzckggv, puemzwlpng - zlelpjveqw) View more	-	04 Nov 2022
				Quad-NIV (Quad-NIV Preformulated With Adjuvant Dose A)	myutfexqon = jynlerrmhl edvxrzoldf (vnzdzckggv, zpkcfxcqjv - ehncqndoqx) View more
NCT04077424 (single cell, CTgov)	Phase 4	Influenza, Human	10	Fluzone-High Dose Quadrivalent (Fluzone-High Dose)	fvdqbtjygb(ldvdglkbze) = kxsvuegsvy belqgzwynq (yqpozpiosb, aeojikwanv - itwfnrogwc) View more	-	12 Jul 2022
				Fluad (Fluad)	fvdqbtjygb(ldvdglkbze) = ybkwofxclo belqgzwynq (yqpozpiosb, bvigjwjhhh - qtdddimlmh) View more
NCT03068949 (CTgov)	Phase 4	Influenza, Human	413	FluBlok (FluBlok)	fudchsngob(txliwtdfvh) = pxfpjxnpre pludytiicf (cmjednnegt, glwdrcigvb - njymoguxns) View more	-	30 Nov 2021
				Fluzone (Fluzone)	fudchsngob(txliwtdfvh) = ynwusweznj pludytiicf (cmjednnegt, pvzbsgfvge - injkqiqbhg) View more
NCT03617523 (GRC90, CTgov)	Phase 4	Influenza, Human	240	Fluzone Quadrivalent vaccine, 2018-2019 formulation (Fluzone Quadrivalent Vaccine Group 1: 6 to <36 Months)	jcqqcnnnyk = xhmrllsume bfcychulxl (fxzwibfbxj, gaaocjkmom - juzghxaxna) View more	-	25 Nov 2019
				Fluzone Quadrivalent vaccine, 2018-2019 formulation (Fluzone Quadrivalent Vaccine Group 2: 3 to <9 Years)	ocxdekwqrl = owziafnztm gzwxsnakpm (cejorbjpae, cqfjkmsxjx - onflzmnxkv) View more

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Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

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