Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Poliovirus Vaccine Inactivated (Human Diploid Cell) - Repevax
Status: marketed in the U.K. and perhaps other European and foreign countries
Organizations involved:
Sanofi Pasteur S.A. – Manuf.; R&D; Tech.; Parent
Sanofi Pasteur MSD – Europe mark.
Crosss Ref.: See the entry for Adacel, with this vaccine essentially involving adding inactivated poliovirus vaccine (IPV) to Adacel.
Description: Repevax is an aqueous formulation combining four vaccines -- diphtheria toxoids; tetanus toxoids; acellular pertussis components; and inactivated poliovirus vaccine (IPV) cultured in Vero (African green monkey kidney) cells -- adsorbed onto alumimum phosphate.
Repevax is supplied as a suspension for injection in prefilled syringes. Each dose (0.5 ml) contains: purified diphtheria toxoid, not less than 2 IU (2 Lf); purified tetanus toxoid, not less than 20 IU (5 Lf); pertussis toxoid (PT), 2.5 µg; purified pertussis filamentous hemagglutinin (FHA), 5 µg; purified pertussis fimbrial agglutinogens 2 + 3 (FIM), 5 µg; purified pertactin (PRN), 3 µg; inactivated poliomyelitis virus type 1, 40 D antigen units; inactivated poliomyelitis virus type 2, 8 D antigen units; inactivated poliomyelitis virus type 3, 32 D antigen units; and aluminium phosphate as adjuvant, 0.33 mg (as aluminium). Other ingredients are 2-phenoxyethanol (preservative); polysorbate 80 (Tween 80); polyribosylribitol, an artificial sweetener; Water for injections; and antibiotics -- neomycin, streptomycin and polymyxin B. Repevax is stored at 2-8˚C (refrigerated) and has a 3 year shelf life.
Nomenclature: dTpa-IPV booster/Sanofi [BIO]; Repevax [TR]; Diphtheria, Tetanus, Pertussis (Acellular, Component) and Poliomyelitis (Inactivated) Vaccine, adjuvanted. [UK]; Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Poliovirus Vaccine Inactivated (Human Diploid Cell) [SY]
Companies.: Repevax is manufactured by Sanofi Pasteur S.A. and marketed in the U.K. and perhaps other European countries by Sanofi Pasteur MSD, a joint venture of Sanofi Pasteur and Merck & Co., Inc.
Indications: [Full text of the "Therapeutic indications:" section of the U.K. SPC]:
REPEVAX is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in persons from the age of three years (see Section 4.2) as a booster following primary immunisation. REPEVAX is not intended for primary immunisation. The use of should be determined on the basis of official recommendations.
Status: Approved in the U.K. on Nov. 2, 2001 (PL6745/0121).
Medical: Repevax may be administered from the age of three years onwards. The use of Repevax in children aged 3 to 5 years is based upon studies in which Repevax was given as the fourth dose (first booster) of diptheria, tetanus, pertussis and poliomyelitis vaccines.
Index Terms:
Companies involvement:
Full monograph
437.5 dTpa-IPV booster/Sanofi
Nomenclature:
dTpa-IPV booster/Sanofi [BIO]
Repevax [TR]
Diphtheria, Tetanus, Pertussis (Acellular, Component) and Poliomyelitis (Inactivated) Vaccine, adjuvanted. [UK]
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed plus Poliovirus Vaccine Inactivated (Human Diploid Cell) [SY]
FDA Class: Biologic BLA
biopharmaceutical products
vaccines, bacterial
vaccines, combination
vaccines, toxoids (inactivated toxins)
vaccines, viral
adw, hepatitis B virus subtype
bacterial culture <!-- bacterialculture -->
Bordetella pertussis
Clostridium tetani
Corynebacterium diphtheriae
vegetable oil extraction
2-phenoxyethanol
accelerated approval (based on surrogate endpoints) (FDAapproved)
aluminum phosphate
Diphtheria Toxoid
filamentous hemagglutinin (FHA), Bordetella pertussis
implants
neomycin
pertactin (69 kDa protein)
pertussis toxin (PT)
polymyxin
polymyxin
polysorbate 80 (Tween 80)
streptolysin O
Tetanus Toxoid
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
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