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Components of
DTaP, Hep B and IPV Vaccine
Excipients Table
Allergens Table
Components Table
 

Indication

For active immunization against diphtheria, tetanus, pertussis, all known subtypes of hepatitis B virus, and 3 types of poliomyelitis, as a 3-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age

Proprietary Name

Pediarix

Manufacturer

GlaxoSmithKline

Viability

Inactivated

Microorganism

Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani, Saccharomyces cerevisiae

Dose

0.5 mL

Approved Ages

6 weeks - <7 years

Route

Intramuscular

Dose form

Suspension

Appearance

Turbid White Suspension after shaking.

Concentration (per 0.5 mL)

Diphtheria, 25 Lf u

Tetanus, 10 Lf u

Pertussis

Pertussis Toxin, 25 mcg

Filamentous hemagglutinin, 25 mcg

Pertactin, 8 mcg

Preservatives

Polysorbate 80 (Tween 80), ≤100 mcg

Adjuvant

Aluminum Hydroxide, ≤0.625 mg

Excipients

Sodium Chloride, 4.5 mg

Formaldehyde, ≤100 mcg

Polysorbate 80 (Tween 80), ≤100 mcg

Thimerosal, <12.5 ng mercury per dose

Neomycin Sulfate, ≤0.05 ng

Polymyxin B, ≤0.01 ng

Yeast, ≤5%

Allergens

Stopper vial may contain dry natural latex rubber

Neomycin, ≤0.05 ng

Polymyxin B, ≤0.01 ng 

Media

 

Bordetella pertussis

Modified Stainer-Scholte liquid medium

PT detoxified using Glutarealdehyde.

FHA and Pertactin detoxified using Formaldehyde

Corynebacterium diphtheriae

Fenton medium containing bovine extract

Detoxified using formaldehyde

Clostridium tetani

Modified Lantham medium derived from bovine casein

Detoxified using Formaldehyde

Saccharomyces cerevisiae

Purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration. The purified HBsAg undergoes dialysis with cysteine to remove residual thimerosal

Packaging

Single-dose (0.5 mL) vials and disposable prefilled syringes

Routine storage

2 to 8 C (36-46 F)

Do Not Freeze

Packaging

August 2012

Table updated June 2013

 

This page was last updated on February 12, 2014

2014 Institute for Vaccine Safety