Last reviewed 2026-05-14 · How we verify

H5N1 vaccine (Arepanrix, GSK)

University Health Network, Toronto · Phase 3 active Biologic

H5N1 vaccine (Arepanrix, GSK) is a inactivated influenza vaccine Biologic drug developed by University Health Network, Toronto. It is currently in Phase 3 development for Prevention of H5N1 avian influenza infection in at-risk populations.

Arepanrix is an inactivated H5N1 influenza vaccine that stimulates the immune system to produce antibodies and cellular immunity against the H5N1 avian influenza virus.

Arepanrix is an inactivated H5N1 influenza vaccine that stimulates the immune system to produce antibodies and cellular immunity against the H5N1 avian influenza virus. Used for Prevention of H5N1 avian influenza infection in at-risk populations.

At a glance

Generic name	H5N1 vaccine (Arepanrix, GSK)
Sponsor	University Health Network, Toronto
Drug class	inactivated influenza vaccine
Modality	Biologic
Therapeutic area	Immunology
Phase	Phase 3

Mechanism of action

The vaccine contains inactivated H5N1 virus particles combined with an AS04 adjuvant system (aluminum hydroxide and MPL) to enhance immune response. It works by presenting viral antigens to the immune system, triggering both humoral (antibody) and cell-mediated immune responses that provide protection against H5N1 infection. The adjuvant amplifies the body's natural defense mechanisms to generate robust and durable immunity.

Approved indications

Prevention of H5N1 avian influenza infection in at-risk populations

Common side effects

Injection site pain or swelling
Myalgia (muscle pain)
Headache
Fatigue
Fever

Key clinical trials

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, GSK) CI brief — competitive landscape report
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Frequently asked questions about H5N1 vaccine (Arepanrix, GSK)

What is H5N1 vaccine (Arepanrix, GSK)?

H5N1 vaccine (Arepanrix, GSK) is a inactivated influenza vaccine drug developed by University Health Network, Toronto, indicated for Prevention of H5N1 avian influenza infection in at-risk populations.

How does H5N1 vaccine (Arepanrix, GSK) work?

Arepanrix is an inactivated H5N1 influenza vaccine that stimulates the immune system to produce antibodies and cellular immunity against the H5N1 avian influenza virus.

What is H5N1 vaccine (Arepanrix, GSK) used for?

H5N1 vaccine (Arepanrix, GSK) is indicated for Prevention of H5N1 avian influenza infection in at-risk populations.

Who makes H5N1 vaccine (Arepanrix, GSK)?

H5N1 vaccine (Arepanrix, GSK) is developed by University Health Network, Toronto (see full University Health Network, Toronto pipeline at /company/university-health-network-toronto).

What drug class is H5N1 vaccine (Arepanrix, GSK) in?

H5N1 vaccine (Arepanrix, GSK) belongs to the inactivated influenza vaccine class. See all inactivated influenza vaccine drugs at /class/inactivated-influenza-vaccine.

What development phase is H5N1 vaccine (Arepanrix, GSK) in?

H5N1 vaccine (Arepanrix, GSK) is in Phase 3.

What are the side effects of H5N1 vaccine (Arepanrix, GSK)?

Common side effects of H5N1 vaccine (Arepanrix, GSK) include Injection site pain or swelling, Myalgia (muscle pain), Headache, Fatigue, Fever.

Drug class: All inactivated influenza vaccine drugs
Manufacturer: University Health Network, Toronto — full pipeline
Therapeutic area: All drugs in Immunology
Indication: Drugs for Prevention of H5N1 avian influenza infection in at-risk populations
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