PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular
Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus
Vaccine Combined] is a noninfectious, sterile, multivalent vaccine for
intramuscular administration manufactured by GlaxoSmithKline Biologicals. It
contains diphtheria and tetanus toxoids, 3 pertussis antigens (inactivated
pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA]
and pertactin [69 kiloDalton outer membrane protein]), hepatitis B surface
antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3
(Saukett). The diphtheria toxoid, tetanus toxoid, and pertussis antigens are
the same as those in INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular
Pertussis Vaccine Adsorbed). The hepatitis B surface antigen is the same as
that in ENGERIX-B® [Hepatitis B Vaccine (Recombinant)].
The diphtheria toxin is produced by growing Corynebacterium
diphtheriae in Fenton medium containing a bovineextract. Tetanus toxin is
produced by growing Clostridium tetani in a modified Latham medium
derived from bovine casein. The bovine materials used in these extracts are
sourced from countries which the United States Department of Agriculture (USDA)
has determined neither have nor are at risk of bovine spongiform encephalopathy
(BSE). Both toxins are detoxified with formaldehyde, concentrated by
ultrafiltration, and purified by precipitation, dialysis, and sterile
The 3 acellular pertussis antigens (PT, FHA, and pertactin)
are isolated from Bordetella pertussis culture grown in modified
Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation
broth; pertactin is extracted from the cells by heat treatment and
flocculation. The antigens are purified in successive chromatographic and
precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde.
FHA and pertactin are treated with formaldehyde.
The hepatitis B surface antigen (HBsAg) is obtained by
culturing genetically engineered Saccharomyces cerevisiae cells, which
carry the surface antigen gene of the hepatitis B virus, in synthetic medium.
The surface antigen expressed in the S. cerevisiae cells is purified by
several physiochemical steps, which include precipitation, ion exchange
chromatography, and ultrafiltration.
The inactivated poliovirus component of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is an
enhanced potency component. Each of the 3 strains of poliovirus is individually
grown in VERO cells, a continuous line of monkey kidney cells, cultivated on
microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell
culture and/or virus culture. Calf serum is sourced from countries the USDA has
determined neither have nor are at risk of BSE. After clarification, each viral
suspension is purified by ultrafiltration, diafiltration, and successive
chromatographic steps, and inactivated with formaldehyde. The 3 purified viral
strains are then pooled to form a trivalent concentrate.
The diphtheria, tetanus, and pertussis antigens are
individually adsorbed onto aluminum hydroxide; hepatitis B component is
adsorbed onto aluminum phosphate. All antigens are then diluted and combined to
produce the final formulated vaccine. Each 0.5-mL dose is formulated to contain
25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated PT,
25 mcg of FHA, 8 mcg of pertactin, 10 mcg of HBsAg, 40 D-antigen Units (DU) of
Type 1 poliovirus, 8 DU of Type 2 poliovirus, and 32 DU of Type 3
Diphtheria and tetanus toxoid potency is determined by
measuring the amount of neutralizing antitoxin in previously immunized guinea
pigs. The potency of the acellular pertussis components (inactivated PT and
formaldehyde-treated FHA and pertactin) is determined by enzyme-linked
immunosorbent assay (ELISA) on sera from previously immunized mice. Potency of
the hepatitis B component is established by HBsAg ELISA. The potency of the
inactivated poliovirus component is determined by using the D-antigen ELISA and
by a poliovirus neutralizing cell culture assay on sera from previously
Each 0.5-mL dose also contains 4.5 mg of NaCl and aluminum
adjuvant (not more than 0.85 mg aluminum by assay). Each dose also contains
≤ 100 mcg of residual formaldehyde and ≤ 100 mcg of polysorbate
80 (Tween 80). Neomycin sulfate and polymyxin B are used in the polio vaccine
manufacturing process and may be present in the final vaccine at ≤ 0.05
ng neomycin and 0.01 ng polymyxin B per dose. The procedures used to
manufacture the HBsAg antigen result in a product that contains ≤ 5% yeast
PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is formulated without preservatives.
The vaccine must be well shaken before administration to
obtain a homogeneous, turbid, white suspension.
Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For
Further Manufacturing Use) is manufactured by Novartis Vaccines and Diagnostics
GmbH & Co. KG, Marburg, Germany. The acellular pertussis antigens, the
hepatitis B surface antigen, and the inactivated poliovirus antigens are
manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. Formulation, filling, testing, packaging, and release of the vaccine are performed by
What are the possible side effects of this vaccine (Pediarix)?
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of...
Read All Potential Side Effects and See Pictures of Pediarix »
Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.