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Institute for Vaccine Safety

Johns Hopkins Bloomberg School of Public Health

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Components of
DTaP
, IPV and Hib Vaccine
Excipients Table
Allergens Table
Components Table
 

Indication

 For active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b

Proprietary Name

Pentacel

Manufacturer

sanofi pasteur

Viability

Inactivated

Microorganism

Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, Hepatitis B virus, Polioviruses type 1, 2, and 3, Haemophilus influenzae type b strain 1482

Dose

0.5 mL

Approved Ages

6 weeks - <5 years

Route

Intramuscular

Dose form

Suspension plus powder

Appearance

uniform, cloudy, white to off-white (yellow tinge)

Concentration (per 0.5 mL)

Diphtheria toxoid, 15 Lf U

Tetanus toxoid, 5 Lf U

Detoxified pertussis toxin, 20 mcg

Filamentous hemagglutinin, 20 mcg

Inactivated polioviruses [40 D-antigen units (DU) Type 1 (Mahoney), 8 DU Type 2 (MEF-1), 32 DU Type 3 (Saukett)]

H. influenzae type b, 10 mcg covalently bound to tetanus toxoid, 24 mcg

Preservatives

None

Adjuvant

Aluminum phosphate, 0.33 mg

Excipients

Formaldehyde (residual), ≤5 mcg

Glutaraldhyde (residual), <50 ng

Bovine serum albumin, ≤50 ng

2-phenoxyethanol (not as a preservative), 3.3 mg

Neomycin, <4 pg

Polysorbate 80, 10 ppm

Allergens

Polymyxin B sulfate, <4 pg

Media

       

Bordetella pertussis

Stainer-Scholte modified by casamino acids and dimethyl-beta-cyclodextrin

Corynebacterium diphtheria

Modified Mueller’s growth medium. Detoxified using formaldehyde Purified using serial ammonium sulfate fractionation and diafiltration

Poliovirus Type 1, Type 2, Type 3 

Each grown in separate cultures of MRC-5 cells, a line of normal human diploid cells

Clostridium tetani  

Modified Mueller-Miller casamino acid medium without beef heart infusion. Detoxified using formaldehyde and purified using ammonium sulfate fractionation and diafiltration.

Haemophilus influenzae type b strain 1482  

Grown in a semi-synthetic medium. The tetanus toxoid for conjugation to PRP is prepared by ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani (Harvard strain) grown in a modified Mueller and Miller medium. The toxoid is filter sterilized prior to the conjugation process.

Packaging

Dose Package containing 5 vials of DTaP-IPV component to be used to reconstitute five single dose vials of lyophilized ActHIB vaccine component

Routine storage

2 to 8° C (36-46° F)

Do Not Freeze

Package Insert last updated

July 2012

updated June 2013

 

This page was last updated on February 12, 2014

© 2014 Institute for Vaccine Safety