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Prepandrix; Pandemrix - influenza virus H5N1, inactivated, vaccine, with AS03 adjuvant; bird flu vaccine; avian influenza vaccine; pandemic influenza vaccine
Company involvement:
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text: Influenza Vaccine, H5N1/GSK Pandemic Influenza vaccine, surface antigen, inactivated; influenza vaccine, pandemic - Prepandrix; Pandemrix; influenza virus H5N1 vaccine; bird flu vaccine; influenza virus H5N1, inactivated, vaccine; avian influenza vaccine; influenza H5N1 virus (A/Indonesia) vaccine Status: vaccine approved in EU in May 2008; being added to U.S. and other countries' stockpiles Organizations involved: GlaxoSmithKline Biologicals S.A. - Manuf.: R&D; Tech.; Europe mark. GlaxoSmithKline plc - Parent Centers for Disease Control & Prevention (CDC) - R&D; Tech.; U.S. mark.. Description: Prepandrix "prepandemic vaccine" is a conventional egg-cultured inactivated influenza virus H5N1 (A/VietNam/1194/2005 NIBRG-14) clade 2 inactivated split-antigen vaccine. Sodium deoxycholate and formaldehyde are used for virus inactivation. The H5N1 clade 2 bulk material is being manufactured from a laboratory version seed virus of the wild-type virus provided by the U.S. Centers for Disease Control and Prevention (CDC). The reference virus, A/Vietnam/1194/2004 (H5N1) NIBRG-14, was developed using reverse genetics, with reassortment strain combining the H5 and N1 segments to with an influenza virus PR8 strain backbone. In addition the H5 was engineered to eliminate the ... truncated (just the beginning) |
Nomenclature:
Infleunza Vaccine, H5N1/GSK [BIO]
Prepandrix [TR]
Pandemrix [TR]
Pandemic Influenza vaccine, surface antigen, inactivated [EU]
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
A/VietNam/1194/2004 NIBRG-14 [EU]
Pandemic influenza vaccine (H5N1) (split, inactivated, adjuvanted) [EU]
avian influenza vaccine [SY]
bird flu vaccines [SY]
influenza H5N1 virus (A/Indonesia)vaccine [SY]
influenza vaccine, pandemic [SY]
influenza virus H5N1, inactivated, vaccine with AS03 adjuvant [SY]
Index Terms:
biopharmaceutical products
bovine materials used<!-- bovinesource -->
chicken source materials
vaccines, inactivated
vaccines, subunit
vaccines, viral
biodefense stockpile (U.S.)
biodefense stockpile, European countries
controlled/gov’t distribution in European counties
controlled/gov’t distribution in U.S.
EU200 Currently Approved in EU
EU666 Biodefense stockpile
UM100 Controlled/Gov't Distribution in US
US666 Biodefense stockpile
EM160 Controlled/Gov't Distribution in EU
chicken embryos (eggs)
influenza virus, H5N1
virus culture
alpha-tocopherol
aluminum adjuvant
AS03 adjuvant
Daronrix
disodium phosphate
formaldehyde
magnesium chloride
octoxynol 10
polysorbate 80 (Tween 80
potassium chloride
potassium dihydrogen phosphate
sodium chloride
sodium deoxycholate
squalene
thiomersal (mercury derivative)
vitamin E
Further information:
Biopharmaceutical Products in the U.S. and European Markets
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