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Influsplit® Tetra
Influsplit® Tetra is a mRNA vaccine Biologic drug developed by ModernaTX, Inc.. It is currently in Phase 3 development for Seasonal influenza prevention (quadrivalent coverage).
Influsplit® Tetra is a quadrivalent mRNA vaccine that encodes influenza virus surface antigens to stimulate immune responses against four strains of influenza.
Influsplit® Tetra is a quadrivalent mRNA vaccine that encodes influenza virus surface antigens to stimulate immune responses against four strains of influenza. Used for Seasonal influenza prevention (quadrivalent coverage).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable. -
Big-pharma sponsor
+3.0pp
ModernaTX, Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Influsplit® Tetra |
|---|---|
| Sponsor | ModernaTX, Inc. |
| Drug class | mRNA vaccine |
| Target | Influenza hemagglutinin and neuraminidase antigens |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine delivers mRNA sequences encoding hemagglutinin and/or neuraminidase proteins from four influenza virus strains (typically two A strains and two B strains). Upon intramuscular injection, the mRNA is translated by host cells to produce viral antigens, which trigger both CD8+ T-cell and antibody-mediated immune responses. This approach aims to provide broader seasonal influenza protection compared to traditional inactivated or live attenuated vaccines.
Approved indications
- Seasonal influenza prevention (quadrivalent coverage)
Common side effects
- Injection site pain or erythema
- Fatigue
- Myalgia
- Headache
- Fever
Key clinical trials
- A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age (PHASE3)
- An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children (PHASE3)
- Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older (PHASE3)
- A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children (PHASE3)
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:
- Influsplit® Tetra CI brief — competitive landscape report
- Influsplit® Tetra updates RSS · CI watch RSS
- ModernaTX, Inc. portfolio CI
Frequently asked questions about Influsplit® Tetra
What is Influsplit® Tetra?
How does Influsplit® Tetra work?
What is Influsplit® Tetra used for?
Who makes Influsplit® Tetra?
What drug class is Influsplit® Tetra in?
What development phase is Influsplit® Tetra in?
What are the side effects of Influsplit® Tetra?
What does Influsplit® Tetra target?
Related
- Drug class: All mRNA vaccine drugs
- Target: All drugs targeting Influenza hemagglutinin and neuraminidase antigens
- Manufacturer: ModernaTX, Inc. — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Seasonal influenza prevention (quadrivalent coverage)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing