Viatim; Vivaxim; hepatitis A virus, inactivated plus Salmonella typhi purified Vi polysaccharide
Status: marketed in Europe and other countries
Organizations involved:
Sanofi Pasteur S.A. – Manuf.: R&D; Tech.; Intl. mark.
Sanofi Pasteur MSD – Europe mark.
Cross ref.: See the entries for component vaccines – Hepatitis A Virus Vaccine, Inactivated (Avaxim); and Typhoid Vaccine/Sanofi (TYPHIM Vi). See also the entries for Hepatitis A Vaccine Products and Typhoid Vaccine Products..
Description: Viatim (Vivaxim) is a bivalent combination vaccine containing formaldehyde inactivated hepatitis A virus (GBM strain) cultured on MRC-5 human diploid cells (essentially, Avaxim) and purified Salmonella typhi Vi (Ty 2 strain) polysaccharide (esentially, TYPHIM Vi) adsorbed onto aluminum hydroxide adjuvant.
Viatim is packaged as a sterile suspension in a dual-chamber by-pass syringe for intramuscular injection. The contents of both chambers are mixed immediately prior to injection by slowly pressing the plunger. Each 1 mL dose of vaccine contains Salmonella typhi Vi polysaccharide (Ty 2 strain), 0.025 mg; and hepatitis A virus antigen,160 ELISA units (determined using an in-house reference); dissolved in a phosphate buffer solution containing sodium chloride, 4.150 mg; sodium phosphate dibasic dihydrate, 0.065 mg; sodium phosphate monobasic, 0.023 mg; and Water for Injection, up to 0.5 mL. From the hepatitis A component, the vaccine also contains aluminum hydroxide, 0.3 mg (aluminium); 2-phenoxyethanol as an antimicrobial preservative, 2.5 microliters (µL); Hanks Medium 199 (supplemented with polysorbate 80), up to 0.5 mL; and bovine serum albumin (BSA), <10 nanograms (ng).
Viatim is marketed as a traveler’s vaccine, combining protection from hepatititis A virus infection with protection from Salmonella typhi infection (typhoid fever)..
Nomenclature: Hepatitis A & Typhoid Vaccine [BIO]; Viatim [TR foreign]; Vivaxim [TR foreign]; hepatitis A virus, inactivated plus Salmonella typhi purified Vi polysaccharide plus hepatitis A virus, inactivated [SY]
Companies.: The vaccine was developed and is manufactured by Sanofi Pasteur S.A., CBER/FDA est. no. 1279, formerly Aventis Pasteur S.A. The vaccine is marketed in verious European countries by Sanofi Pasteur MSD (formerly Aventis Pasteur MSD), a joint venture of Sanofi Pasteur S.A. and Merck & Co., Inc. Sanofi Pasteur S.A. markets the vaccine is various other countries worldwide, but not in the U.S.
Status: The vaccine is approved and marketed in various individual European countries, including the U.K. and various other countries worldwide. In most territories, the vaccine is administered to persons 16 year of age or older. Clinical trials began in 1991. The vaccine has not received centralized European Union approval.
Market: Sanofi Pasteur’s hepatitis A virus vaccines, Avaxim and Viatim, have captured ~10–15% of the global market for immunization against hepatitis A, despite not being marketed in the U.S.
In April 2005, the U.K. National Health Service (NHS) cost was reported to be £32.49 (~$62.21).
Index Terms:
Companies involvement:
Full monograph
467 Hepatitis A & Typhoid vaccine
Nomenclature:
Hepatitis A & Typhoid Vaccine [BIO]
Viatim [TR]
Vivaxim [TR]
hepatitis A virus, inactivated plus Salmonella typhi purified Vi polysaccharide plus hepatitis A virus, inactivated [SY]
Salmonella typhi vaccine and hepatitis A virus vaccine [SY]
FDA Class: Biologic BLA
biopharmaceutical products
bovine materials used<!-- bovinesource -->
bovine materials used<!-- bovinesource -->
vaccines, combination
vaccines, inactivated
Gb-23-902-531
hamster source materials
hepatitis A virus (HAV) HM-175 strain
media, serum-free
Salmonella typhi
2-phenoxyethanol
albumin, bovine
aluminum hydroxide
bovine serum albumin (BSA)
formaldehyde
hamster source materials
media, serum-free
Salmonella typhi Vi (Ty 2 strain)
sodium phosphate, dibasic
sodium phosphate, monobasic
Sterile Water for Injection
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
Copyright© 2020, Biotechnology Information Institute