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H5N1 vaccine (Arepanrix)
Arepanrix is an inactivated split-virion H5N1 influenza vaccine that stimulates the immune system to produce antibodies against the H5N1 avian influenza virus.
Arepanrix is an inactivated split-virion H5N1 influenza vaccine that stimulates the immune system to produce antibodies against the H5N1 avian influenza virus. Used for Prophylaxis of H5N1 influenza infection in at-risk populations.
At a glance
| Generic name | H5N1 vaccine (Arepanrix) |
|---|---|
| Also known as | Arepanrix, GSK |
| Sponsor | Canadian Immunization Research Network |
| Drug class | inactivated split-virion influenza vaccine with adjuvant |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains inactivated H5N1 virus particles that have been chemically split to reduce reactogenicity while preserving immunogenicity. It is formulated with an oil-in-water emulsion adjuvant (AS04) that enhances the immune response by activating both innate and adaptive immunity, promoting stronger and more durable antibody production against H5N1 surface antigens.
Approved indications
- Prophylaxis of H5N1 influenza infection in at-risk populations
Common side effects
- Injection site pain or erythema
- Myalgia
- Headache
- Fatigue
- Fever
Key clinical trials
- Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart (PHASE4)
- Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial) (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:
- H5N1 vaccine (Arepanrix) CI brief — competitive landscape report
- H5N1 vaccine (Arepanrix) updates RSS · CI watch RSS
- Canadian Immunization Research Network portfolio CI