Components of

DTaP+IPV Vaccines

Components Page
Excipients Table
Allergens Table
       
Name Kinrix Quadracel
Manufacturer GlaxoSmithKline Biologicals sanofi pasteur
Viability Inactivated Inactivated
Indicated Ages 4-6 years 4-6 years
Dose 0.5 mL 0.5 mL
Schedule 5th dose in DTaP series; 4th dose in IPV series with prior DTaP with Infanrix and/or Pediatrix for the first 3 doses and Infanrix for the 4th dose 5th dose in DTaP series; 4th or 5th dose in IPV series with prior Pentacel and/or Daptacel for the first 4 doses
Route Intramuscular Intramuscular
Appearance Homogeneous, turbid, white suspension Uniform, white, cloudy suspension 
Concentration • Diphtheria toxoid, 25 Lf
• Tetanus toxoid, 10 Lf
• Pertussis toxin (inactivated), 25 mcg
• Filamentous hemagglutinin, 25 mcg
H. influenzae type b, 10 mcg
• Pertactin, 8 mcg
• Type 1 Poliovirus, 40 DU
• Type 2 Poliovirus, 8 DU
• Type 3 Poliovirus, 32 DU
• Diphtheria toxoid, 15 Lf
• Tetanus toxoid, 5 Lf
• Pertussis toxin (acellular), 20 mcg
• Filamentous hemagglutinin, 20 mcg
• Fimbriae types 2 and 3, 5 mcg
• Pertactin, 3 mcg
• Type 1 Poliovirus, 40 DU
• Type 2 Poliovirus, 8 DU
• Type 3 Poliovirus, 32 DU
Preservative None in US version None
Adjuvant Aluminum Hydroxide, ≤0.6 mg aluminum Aluminum Phosphate, 1.5 mg (0.33 Al)
Excipients • Sodium Chloride, 4.5 mg
• Formaldehyde, ≤100 mcg
• Polysorbate 80 (Tween 80), ≤100 mcg
• Neomycin, ≤0.05 ng
• Polymyxin B, ≤0.01 ng
• Formaldehyde, ≤5 mcg
• Polysorbate 80, 10 ppm
• Glutaraldehyde, <50 ng
• Neomycin, <4 pg
• Polymyxin B sulfate, <4 pg
Allergens • The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals.
• Neomycin, ≤0.05 ng
• Polymyxin B, ≤0.01 ng
• Neomycin, <4 pg
• Polymyxin B sulfate, <4 pg
Media Bordetella pertussis
• Modified Stainer-Scholte liquid medium
PT detoxified using Glutarealdehyde
• FHA and PT detoxified using Formaldehyde

Corynebacterium diphtheria
• Fenton medium containing bovine extract
• Detoxified using Formalin

Clostridium tetani
• Modified Lantham medium derived from bovine casein
• Detoxified using Formalin
Corynebacterium diphtheria
• Modified Mueller’s growth medium
• Detoxified using Formaldehyde

Clostridium tetani
Modified Mueller-Miller casamino acid medium without beef heart infusion
• Detoxified using Formaldehyde

Bordetella pertussis
• Grown in Stainer-Scholte medium modified by the addition of casamino acids and dimethylbeta-cyclodextrin
• PT detoxified using Glutarealdehyde
• FHA treated with Formaldehyde
Packaging Single-dose (0.5 mL) vials and disposable prefilled TIP-Lok syringes Single dose vials in packages of 10 vials
Storage 2-8°C (35-46°F)
Do not freeze
2-8°C (35-46°F)
Do not freeze
PI date Oct 2016 Mar 2015
    table last updated 10/16/17