Vaccine/GSK
Measles and Rubella Virus Vaccine Live - Eolarix
Status: marketed in European countries
Organizations involved:
GlaxoSmithKline Biologicals S.A. – Manuf.: R&D; Tech.; Intl. mark.
GlaxoSmithKline plc – Parent
SmithKline Beecham Biologicals S.A. – R&D; Tech.; Former
Cross ref.: See the entry for Measles & Rubella Virus Vaccine/Merck (M-R-Vax II), and its related vaccines.
Description: Eolarix is a lyophilized (freeze-dried) formulation of a bivalent combination vaccine containing a highly attenuated live measles virus (Schwarz strain) cultured in chicken embryos (eggs) and and live rubella virus (RA27/3 strain) cultured in a human diploid cell line. Each 0.5 ml dose of reconstituted vaccine contains at least 1,000 TCID50 of the measles virus Schwarz strain and 1,000 TCID50 of rubella virus RA27/3 strain, with not more than 25 µg (17 IU) of neomycin sulphate. Eolarix has a shelf life of two years, when stored at 2-8˚C (refrigerated). Eolarix may contain traces of chick embryo proteins, and should not be used in persos with severe hypersensitivity to eggs (past anaphylactoid reactions to egg ingestion).
Nomenclature: Measles & Rubella Virus Vaccine/GSK [BIO]; Eolarix [TR]; Measles and Rubella Virus Vaccine Live [FDA, if approved in U.S.]
Companies.: The vaccine was developed by SmithKline Beecham Biologicals S.A. (now GlaxoSmithKline Biologicals S.A.) and is manufactured and marketed internationally by GlaxoSmithKline Biologicals S.A., a subsidiary of GlaxoSmithKline plc.
Status: Eolarix received U.K. approval on July, 22, 1994, and the UK government started using Eolarix in national vaccination campaigns. Eolarix is also approved in Canada. The vaccine is also approved in various other European countries and other countries worldwide. The vaccine is not approved in the U.S.
Trials: In clinical studies, Eolarix produced seroconversion rates approaching 100% for measles and rubella. Similar seroconversion rates were obtained with the monovalent vaccines, indicating that there is no interference between the Eolarix and its component vaccines at the doses used in Eolarix.
Index Terms:
Companies involvement:
Full monograph
495 Measles & Rubella Virus
Nomenclature:
Measles & Rubella Virus Vaccine/GSK [BIO]
Eolarix [TR]
Measles and Rubella Virus Vaccine Live [FDA, if approved in U.S.]
FDA Class: Biologic BLA
biopharmaceutical products
bovine materials used<!-- bovinesource -->
chicken source materials
human materials used<!-- humansource -->
live microorganisms (as active agent)
vaccines, combination
vaccines, live
vaccines, viral
cells, human
chicken embryo (egg) culture
human chorionic gonadotropin (hCG)
measles prophylaxis
RA 27/3 Wistar Inst. strain, rubella virus
rubella virus Wistar Inst. RA 27/3 strain
Sauton medium
virus culture
North American coral snake
EU200 Currently Approved in EU
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM001 Marketed Product in EU
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