Components of

DTaP+HepB+IVP Vaccine


Vaccine	Pediarix
Manufacturer	GlaxoSmithKline Biologicals
Viability	Inactivated
Indicated Ages	6 weeks - 6 years (before 7th birthday)
Dose	0.5 mL
Schedule	3 dose series at 2, 4, and 6 mos
Route	Intramuscular
Appearance	Homogeneous, turbid, white suspension
Concentration	• Diphtheria Toxoid, 25 Lf • Tetanus Toxoid, 10 Lf • Pertussis Toxin inactivated, 25 mcg • Filamentous hemagglutinin, 25 mcg • Pertactin, 8 mcg • HBsAG, 10 mcg • Type 1 Poliovirus, 40 DU • Type 2 Poliovirus, 8 DU • Type 3 Poliovirus, 32 DU
Preservative	None
Adjuvant	Aluminum, ≤85 mcg
Excipients	• Calf Serum Albumin, amount not specified • Aluminum, ≤0.85 mcg • Bovine Casein, amount not specified • Bovine Extract, amount not specified • Formaldehyde, ≤100 mcg • Glutaraldehyde, amount not specified • Lactalbumin Hydrolysate, amount not specified • Neomycin, ≤0.05 ng • Polymyxin B, ≤0.01 ng • Polysorbate 80 (Tween 80), ≤100 mcg • Sodium Chloride, 4.5 mg • Vero Cells, amount not specified • Yeast, ≤5%
Allergens	None
Media	Bordetella pertussis • Modified Stainer-Scholte medium • Modified by Casamino Acids and Dimethyl-beta-cyclodextrin Corynebacterium diphtheria • Fenton medium containing a bovine extract • Detoxified using formalin • Concentrated by ultrafiltration • Purified by precipitation, dialysis, and sterile filtration Clostridium tetani • Modified Latham medium derived from bovine casein • Detoxified using formalin • Concentrated by ultrafiltration • Purified by precipitation, dialysis, and sterile filtration Poliovirus Type 1, Type 2 and Type 3 • Each grown in VERO cells Hepatitis B survace antigen • Expressed in S cerevisiae cells • Purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration
Diluent	None
Packaging	• Single-dose prefilled TIP-Lok syringes (without needles) • 10-packs of syringes
Storage	• 2 to 8° C (36-46° F) • Do Not Freeze
PI date	11/2019
		table last updated 1/22/2021

Components of

DTaP+HepB+IVP Vaccine

Pediarix