Components of

DTaP, HebB and IPV Hib Vaccines

Components Page
Excipients Table
Allergens Table
Name 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 salts, ≤0.85 mcg
Excipients • Aluminum salts, ≤0.85 mcg
• Sodium Chloride, 4.5 mg
• Formaldehyde, ≤100 mcg
• Polysorbate 80 (Tween 80), ≤100 mcg
• Neomycin sulfate, ≤0.05 ng
• Polymyxin B, ≤0.01 ng
• 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 antifgen
• Expressed in S cerevisiae cells
• Purified by several physiochemical steps, which include precipitation, ion exchange chromatography, and ultrafiltration
 
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 September 2016  
  table last updated 10/31/17