Drug intelligence / Profile preview

prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Development stage
Approved
Lead developer
GSK
Modality
Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

**Prepandrix** is GSK's egg-derived, monovalent, AS03-adjuvanted, inactivated split-virion H5N1 influenza A vaccine developed for prepandemic active immunisation. The final EU-authorised presentation contained 3.75 micrograms of haemagglutinin from an A/Indonesia/05/2005 H5N1-like reassortant strain per 0.5 mL dose, formulated with the AS03 oil-in-water adjuvant system containing squalene, DL-alpha-tocopherol, and polysorbate 80. It stimulates antigen-specific humoral immune responses against influenza A H5N1 haemagglutinin to provide preparedness against a potential H5N1 influenza pandemic. Prepandrix received EU marketing authorisation in 2008, but its authorisation was withdrawn on 17 December 2020 at GSK's request after permanent discontinuation of commercial marketing. ([ema.europa.eu](https://www.ema.europa.eu/en/documents/product-information/prepandrix-epar-product-information_en.pdf))

Brand names
Prepandrix
Other names
AS03-H5N1 vaccineAS-03-H5N1 vaccineAS 03-H5N1 vaccineInfluenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedPandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
02

Targets

HA (Hemagglutinin)Neuraminidase

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