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Vaccination with Fluval AB
Vaccination with Fluval AB is a Biologic drug developed by Fluart Innovative Vaccine Ltd, Hungary. It is currently in Phase 1 development. Also known as: Fluval AB, 5609.
Fluval AB Novo suspension for injection is a small molecule vaccine used for the prevention of influenza in children and adolescents. It is administered via intramuscular injection in a single dose of 0.5 ml.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Vaccination with Fluval AB |
|---|---|
| Also known as | Fluval AB, 5609 |
| Sponsor | Fluart Innovative Vaccine Ltd, Hungary |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (PHASE4)
- Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents (PHASE3)
- Yearly Licence Tolerability and Immunogenicity Study of Fluval AB Seasonal Influenza Vaccine to be Used in the 2012/2013 Vaccination Season (PHASE4)
- Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents (NA)
- Tolerability and Immunogenicity Study of Fluval AB Influenza Vaccine in Adults and Elderly Persons (PHASE4)
- Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People (NA)
- A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects (NA)
- Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vaccination with Fluval AB CI brief — competitive landscape report
- Vaccination with Fluval AB updates RSS · CI watch RSS
- Fluart Innovative Vaccine Ltd, Hungary portfolio CI
Frequently asked questions about Vaccination with Fluval AB
What is Vaccination with Fluval AB?
Who makes Vaccination with Fluval AB?
Is Vaccination with Fluval AB also known as anything else?
What development phase is Vaccination with Fluval AB in?
Related
- Manufacturer: Fluart Innovative Vaccine Ltd, Hungary — full pipeline
- Also known as: Fluval AB, 5609
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing