A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Certiva Online, Description, Chemistry, Ingredients - Certiva
Certiva Online, Description, Chemistry, Ingredients - Certiva
DESCRIPTION
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine
Adsorbed (CertivaTM)
CertivaTM (Diphtheria and Tetanus sterile
combination of diphtheria, Toxoids and Acellular Pertussis Vaccine
Adsorbed) is a tetanus, and pertussis
toxoids (one pertussis
antigen, inactivated
pertussis toxin),
adsorbed onto aluminum
hydroxide.1 It is intended for intramuscular injection
only. After shaking, CertivaTM is a homogeneous
white suspension. The pertussis
toxin (PT) is isolated
from Phase 1 Boraktella pertussis grown in modified Stainer-Scholte
medium. After purification by afIinity chromatography, which includes
the use of fetuin, a bovine serum protein,
as an aflinity ligand, PT
is detoxified using hydrogen
peroxide.
Diphtheria toxin is derived
from Corynebacterium diphtheriae grown in Stainer’s Diphtheria
Culture Medium, containing casein
hydrolysate, and is purified by fractional precipitation
with ammonium sulfate.
Tetanus toxin is derived from Clostridium tetani grown in
modified Mueller and Miller Medium, containing casein
hydrolysate, and is purified by precipitation with ammonium
sulfate.2 The purified diphtheria
and tetanus toxins are detoxified using formaldehyde.
Each antigen is individually
adsorbed onto aluminum
hydroxide. 2 Each 0.5 ml
dose of vaccine
is formulated to contain 15 Lf diphtheria toxoid, 6 Lf tetanus
toxoid, 40 mcg pertussis
toxoid, 0.5 mg aluminum
as aluminum hydroxide, and is preserved with 0.01% thimerosal
(mercury derivative). The product
may contain residual
fetuin. The residual
free formaldehyde content by assay
is less than or equal to 10 ppm. The diphtheria
and tetanus toxoids each induce not less than 2 units of antitoxin
per ml
in the guinea pig potency
test. The potency of
the pertussis toxoid
is evaluated by measurement of antibody
titers to pertussis
toxin in immunized mice
using an ELISA.
Diphtheria and tetanus
toxoid bulks for further
manufacturing use are produced by Statens Seruminstitut, Copenhagen,
Denmark. The pertussis
toxoid is manufactured by North American Vaccine, Inc., Beltsville,
Maryland. Final formulation and release
of Certiva TM are conducted by North American Vaccine,
Inc.
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