Diphtheria, tetanus and hepatitis B (recombinant) vaccine, adsorbed - Primavax
Status: formerly marketed in Europe
Organizations involved:
Aventis Pasteur S.A. – Manuf.; R&D; Tech.; Former
Merck & Co., Inc. – Manuf. other; Former
Aventis Pasteur MSD – Europe mark.; Former
Cross ref.: See the entries for Diphtheria Toxoid Products; Tetanus Toxoid Products; and Hepatitis B Vaccine, rDNA/Merck (Recombivax HB).
Description: Primavax was a trivalent (three component) vaccine combining diphtheria and tetanus toxoids (inactivated toxin) components adsorbed on aluminum-based adjuvant from Aventis Pasteur S.A. plus recombinant Saccharomyces cerevisiae (yeast)-expressed hepatitis B surface antigen (HBsAg) vaccine with aluminum hydroxide adjuvant (Recombivax HB) from Merck & Co., Inc. Each 0.5 mL dose contained purified diphtheria toxoid (≥30IU), purified tetanus toxoid (≥40 IU) and recombinant hepatitis B surface antigen (5 µg) in suspension in a prefilled glass syringe for intramuscular injection,
Nomenclature: DT-HBV, rDNA [BIO]; Diphtheria, tetanus and hepatitis B (recombinant) vaccine, adsorbed [INN; EU common name]; Primavax [TR]
Companies.: Primavax was developed and manufactured (diphtheria and tetanus toxoids, and blending, filling and packaging) by Aventis Pasteur S.A. (now Sanofi Aventis S.A.). Merck & Co., Inc. manufactured the recombinant hepatitis B component. Aventis Pasteur MSD, a joint venture of Aventis Pasteur S.A. and Merck & Co., Inc., formerly marketed the vaccine in Europe.
Status: Primavax received centralized European Union MAA approval on Feb. 5, 1998 (also reported as Feb. 2). Approval was withdrawn at the sponsor’s request on Aug. 3, 2000.
Indications: [European Union]: “Active immunization against hepatitis B; caused by all known subtypes, diphtheria and tetanus in infants for primary vaccination, for booster according to national vaccination policies.”
Index Terms:
Companies involvement:
Full monograph
428 DT-HBV, rDNA
Nomenclature:
DT-HBV, rDNA [BIO]
Primavax [TR]
Diphtheria, tetanus and hepatitis B (recombinant) vaccine, adsorbed [INN]
FDA Class: Biologic BLA
biopharmaceutical products
biopharmaceutical products
recombinant DNA
vaccines, bacterial
vaccines, combination
vaccines, viral
bacterial culture <!-- bacterialculture -->
Clostridium tetani
Corynebacterium diphtheriae
hepatitis B virus (HBV)
Diphtheria Toxoid
Tetanus Toxoid
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
North American coral snake
North American coral snake
EU011 Approved Formerly in EU/withdrawn
UM999 Not Available/Not Marketed in US
US000 never filed/no plans
EM999 Not Available/Not Marketed in EU
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