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Components of
Hib Vaccine
Excipients Table
Allergens Table
Components Table
 

Indication

Induction of active immunity against invasive diseases caused by Haemophilus influenzae type b

Proprietary Name

HibTITER

PedvaxHIB

ActHIB/OmniHIB

Hiberix

Manufacturers

Wyeth-Lederly

Merck

sanofi pasteur/ GlaxoSmithKline

GlaxoSmithKline

Viability

Inactivated

Inactivated

Inactivated

Inactivated

Microorganism

Haemophilus influenzae type b

Corynebacterium diptheriae C7

H. influenza

Neisseria meningitidis

H. influenza (tetanus toxoid conjugate)

Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Clostridium tetani

Dose

0.5 mL

0.5 mL

0.5 mL

0.5 mL

Route

Intramuscular

Intramuscular

Intramuscular

Intramuscular

Dosage form

Solution

Suspension

Powder for solution

Sterile, Lyophilized powder

Appearance

Clear, Colorless

Slightly opaque white

Clear, Colorless after mixing

Clear, Colorless after reconstitution

Concentration (per 0.5 mL)

Haemophilus b saccharide, 10 mcg

Haemophilus b PRP, 7.5 mcg

Polysaccharide, 10 mcg

Hib Polysaccharide, 10 mcg

Preservatives

None

None

None

None

Adjuvant

CRM197 protein, 25 mcg

Neisseria meningitides OMPC, 125 mcg

Aluminum hydrosyphosphate sulfate, 225 mcg

Sodium chloride, 0.9%

Tetanus toxoid, 24 mcg

Tetanus toxoid, 25 mcg

Excipients

None

None

8.5% sucrose, Ammonium sulfate

Formalin

Lactose, 12.6 mg

Formaldehyde, residual ≤0.05mcg

Allergens

None

None

None

None

Media

Casamino acids

Yeast Extract

Complex fermentation

Semisynthetic medium

Synthetic medium

Packaging

Vial, 1 Dose (5 per package)

Box of 10 single-dose vials

Box of 5 single dose vials packaged with diluent

Pakcage of 10 Single-dose vials

Routine Storage

2 to 8 C (36-46 F)

Do Not Freeze

2 to 8 C (36-46 F)

Do Not Freeze

2 to 8 C (36-46 F)

Do Not Freeze

2 to 8 C (36-46 F)

Protect from light

Do Not Freeze

updated May 2010

This page was last updated on February 12, 2014

2014 Institute for Vaccine Safety