Components of

DTaP, IPV and Hib Vaccines

Components Page
Excipients Table
Allergens Table
     
Name Pentacel  
Manufacturer sanofi pasteur
Viability Inactivated
Indicated Ages 6 weeks - 4 years (before 5th birthday)  
Dose 0.5 mL  
Schedule 4 dose series at 2, 4, 6, and 15-18 mos  
Route Intramuscular
Appearance Uniform, cloudy, white to off-white (yellow tinge)  
Concentration • Diphtheria toxoid, 15 Lf
• Tetanus toxoid, 5 Lf
• Acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)]
• Inactivated polioviruses [40 D-antigen units (DU) Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)]
• PRP of H. influenzae type b, 10 mcg covalently bound totetanus toxoid (PRP-T), 24 mcg
 
Preservative None  
Adjuvant Aluminum phosphate, 1.5 mcg
Excipients • 1.5 mg aluminum phosphate (0.33 mg aluminum)
• Polysorbate 80, approximately 10 ppm by calculation
• Sucrose, 42.5 mg
• ≤Formaldehyde, 5 mcg
• Glutaraldehyde, <50 ng
• Bovine serum albumin, ≤50 ng
• 2-Phenoxyethanol, 3.3 mg (0.6% v/v)
• Neomycin, ≤4 pg
• Polymyxin B sulfate, ≤4 pg
Allergens None
Media Bordetella pertussis
• Stainer-Scholte medium
• Modified by Casamino Acids and Dimethyl-beta-cyclodextrin

Corynebacterium diphtheria
• Modified Mueller’s growth medium
• Purified using Ammonium Sulfate Fractionation
• Detoxified using Formalin
• Adsorbed onto aluminum phosphate
• PT, FHA and PRN isolated separately from the supernatant culture medium.
• Pertussis antigens purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography.
• PT detoxified with glutaraldehyde
• FHA treated with formaldehyde
• Residual aldehydes removed by ultrafiltration
• Individual antigens adsorbed separately onto aluminum phosphate

Clostridium tetani
• Mueller-Miller casamino acid medium (without beef heart infustion)
• Detoxified using formalin
• Purified by Ammonium Sulfate fractionation and defiltration
• Adsorbed onto aluminum phosphate

Poliovirus Type 1, Type 2 and Type 3
• Each grown in separate cultures of MRC-5 cells by the microcarrier method
• The cells are grown in CMRL (Connaught Medical Research Laboratories) 1969 medium, supplemented with calf serum
• For viral growth, the culture medium is replaced by Medium 199, without calf serum.
• After clarification and filtration, the viral suspensions are concentrated by ultrafiltration, and purified by liquid chromatography steps
• The monovalent viral suspensions are inactivated with formaldehyde
 
Packaging Five single-dose packages  
Storage 2 to 8° C (35-46° F) - Do Not Freeze
PI date September 2016  
  table last updated 10/31/17