TheraRadar
Data updated: May 26, 2026

Flucelvax, Flucelvax Quadrivalent (influenza vaccine)

Approved 2012-11-19
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
13
Years on Market

Details

Status
Disc
First Approved
2012-11-19
Routes
Intramuscular
Dosage Forms
Injection

Companies

CSL Behring
Active Ingredient: Influenza Vaccine , Influenza Vaccine , Influenza Vaccine , Influenza Vaccine , Influenza Vaccine

Flucelvax, Flucelvax Quadrivalent Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2012 to 2012
Nov 2012 ORIGINAL
Update · CBER biologic (Purple Book)

What Flucelvax, Flucelvax Quadrivalent Treats

1 FDA approvals

Originally approved for its first indication in 2012 .

  • Other (1)
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Clinical Trial Registry

47 trials
Trial Sponsor ID Phase Status Title
NCT06336317 ELIMINATE ELIMINATE-2024 Ph 4 recruiting Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
NCT05294588 21-0498 DMID 21-0018, U01AI162457-01 Ph 2 completed Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae
NCT06279871 results posted ARCT-2303-01 Ph 3 completed Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults
NCT05074303 M-Unity results posted IRB202101959 Ph 2 completed Beta-glucan and Immune Response to Influenza Vaccine
NCT06864143 mRNA-1083-P202 Ph 2 completed A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
NCT06355232 Vaxine-2301 Ph 1 recruiting Covid-19 and Influenza Oral Vaccine Study
NCT06141655 GALFLU Ph 4 completed HD vs SD Quadrivalent Influenza Vaccine in Adults Aged 65 to 79 Years in Galicia
NCT06097273 results posted mRNA-1083-P301 Ph 3 completed A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
NCT03955991 VSMART 20160525 Ph 4 completed VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)
NCT05091307 results posted CR109083 2021-003953-43, VAC31518COV3005 Ph 3 completed A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults
NCT06716567 MADI-01 B762020201013 Ph 4 completed Maternal Determinants of Immunity to Influenza
NCT05654441 BSB results posted 22-1024 2047344 Ph 4 completed Body and Social Behavior
NCT05519839 COVID-19 2019nCoV-CIC-E-201 Ph 2 completed A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine
NCT05116917 INFLUENCE GI 2118 Ph 2 terminated Immunotherapy Combined With Radiation and Influenza Vaccine for Pancreatic Cancer.
NCT02545868 results posted BN29739 2015-001357-32 Ph 3 completed A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
NCT05616546 STUDY00003852 75N93021C00017 Ph 4 recruiting Bone Marrow and Peripheral Blood Immune Responses Study
NCT04176133 results posted 19-004847 Ph 2 completed Entolimod on Immunosenescence in Healthy Geriatric Subjects Receiving Influenza Vaccination
NCT05909423 FLU-IMMUNE 2023-503228-17-00 Ph 2 not yet recruiting Combining Intratumoral Flu Vaccine and Systemic Pembrolizumab in Patients With Early pMMR Colorectal Cancer
NCT01693380 Xo_Gripe BUTANTAN Ph 4 completed Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza
NCT02998736 PERIOP-04 20160855-01H Ph 1 completed Trial of Perioperative Tadalafil and Influenza Vaccination in Cancer Patients Undergoing Major Surgical Resection of a Primary Abdominal Malignancy
NCT03658629 results posted qNIV-E-201 Ph 2 terminated Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
NCT04091880 EV71-Flu-Combine-01 Ph 4 completed Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine
NCT04526574 results posted B7471004 Ph 3 completed Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
NCT03277703 1077651 Ph 2 completed Flu Vaccine Response in Patients on Biologic Therapies
NCT01034254 Mothers'Gift Mothers'Gift 241 Field Trial Ph 3 completed Field Trial of Maternal Influenza Immunization in Asia
NCT02831608 IAMI IAMI-2014 IAMI Trial Ph 4 completed Study on the Effect of Influenza Vaccination After Heart Attack on Future Cardiovascular Prognosis
NCT02268500 VACC-HeFT results posted 2014-0656 Ph 4 completed VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
NCT02565277 AMRIC Dr.Atoui Ph 4 completed The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
NCT03996538 VEME 19-205-2 18155 Ph 1 completed Vaccination Efficacy With Metformin in Older Adults
NCT00868218 PANFLUVAC results posted PANFLUVAC-2008, Version 2 EU PANFLUVAC 44115 Ph 1 completed Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
NCT02519855 results posted V211-062 Ph 3 completed Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
NCT01924169 results posted 2013-0371 NCI-2014-01058 Ph 2 terminated Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)
NCT03572491 VSI-III-01/2017 Ph 3 completed Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine
NCT02290691 IIJI results posted PJ-501-14 Ph 4 completed Inactivated Influenza Via Jet Injection
NCT02655874 TROPICS1 2015/01047 Ph 4 completed Tropical Influenza Control Strategies for the Elderly
NCT03028116 VSI VSI-I-01/2016 Ph 1 completed Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine
NCT02311855 1076 Ph 4 completed Duration of Immune Response to Influenza Vaccination in Patients With RA
NCT01403376 TERIVA results posted PDY11684 2011-001160-21, U1111-1115-2742 Ph 2 completed Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
NCT01761435 TraNsgripe TraNsgripe1-2 Ph 3 completed Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
NCT00735020 V104P1 Ph 1 completed Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines
NCT01488188 results posted FM-01 V1 Ph 1 completed Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route
NCT00918268 V71_10S 2009-010598-19 Ph 2 completed Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2009/2010 Recommended in Northern Hemisphere in Non-elderly Adult and in Elderly Subjects
NCT01013675 S203.2.009 2009-014767-40 Ph 2 completed Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly
NCT00915187 NX09-4 Ph 2 completed Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly
NCT00999206 S203.3.013 Ph 3 completed Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine
NCT00607178 IVCAD SBMU- 86-03-105-5433A SMMC- 13861008A Ph 2, Ph 3 completed The Efficacy of Influenza Vaccine in Reducing Cardiovascular Events in Patients With Coronary Artery Diseases
NCT00607217 SBMU- 86-03-105-5433B SMMC- 13861008B Ph 2, Ph 3 completed The Efficacy of Influenza Vaccination in Patients With Coronary Artery Diseases
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Flucelvax, Flucelvax Quadrivalent FDA Label Details

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Data Sources

FDA Approval: BLA125408 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.