TheraRadar
Data updated: May 26, 2026

Fluad (influenza vaccine, adjuvanted)

Approved 2015-11-23
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Disc
First Approved
2015-11-23
Routes
Intramuscular
Dosage Forms
Injection

Companies

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

Fluad Approval History

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

What Fluad Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • Other (1)
📋

Clinical Trial Registry

10 trials
Trial Sponsor ID Phase Status Title
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
NCT04101838 IRB-300003914 UAB Ph 4 active not recruiting B Cell and Antibody Response to Seasonal Influenza Vaccines in Younger and Older Adults
NCT05291676 2000035834 U19AI089992, 0409027018 Ph 2 recruiting Systems Investigation of Vaccine Responses in Aging and Frailty
NCT03312699 SLVP033 40216 R01AI130398-01 Ph 1 completed Effects of Aging on Primary and Secondary Vaccine Responses
NCT02871206 AV-IIV Ph 4 completed Adjuvanted Inactivated Vaccine Versus Inactivated Influenza Vaccine in Hutterite Children
NCT02523287 BioVacSafe - Fluad Ph 4 completed Placebo Controlled Study to Generate Data Characterising Clinical Events, Physiological Responses and Immune Responses
NCT04077424 results posted single cell Ph 4 completed Senescent Immunity in Elders and Vaccine Responses (SILVER)
NCT02686398 KUGH13170 Ph 4 completed Immunogenicity of a Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Undergoing Hemodialysis
NCT01368796 PCIRNRT09 H11-01457 Ph 4 completed Comparison of 4 Influenza Vaccines in Seniors
NCT02215863 FLUPCV13 Ph 4 completed Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

Fluad FDA Label Details

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Data Sources

FDA Approval: BLA125510 → Trials: ClinicalTrials.gov →

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