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Institute for Vaccine Safety

Johns Hopkins Bloomberg School of Public Health

615 N. Wolfe Street

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Baltimore, MD 21205

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Components of
Seasonal Influenza Vaccines 2013/14
Excipients Table
Allergens Table
Components Table
Components: Flucelvax-Fluvirin
Components Fluzone all formulas
     

Proprietary Name

Afluria Agriflu Fluarix Fluarix Quad Flublok

Manufacturers

CSL Limited Novartis GlaxoSmithKline GlaxoSmithKline Protein Sciences Corp

Viability

Inactivated

Inactivated

Inactivated

Inactivated

 

Approved Ages

5 years* and older

18 years and older

3 years and older

3 years and older

18-49 yrs

Pediatric Dose

≥5 years: 0.5 mL

NA

≥3 years: 0.5 mL

3 years: 0.5 mL

NA

Dose

0.5 mL

0.5 mL

0.5 mL

0.5 mL

0.5 mL

Route

Intramuscular

Intramuscular

Intramuscular

Intramuscular

Intramuscular

Dose form

Solution

Solution

Solution

Solution

Solution

Appearance

Colorless to slightly opalescent

Clear

Colorless to slightly opalescent

Colorless to slightly opalescent

Clear and colorless

Concentration (per 0.5 mL)

A/California/7/2009 (H1N1), NYMC X-181, 15 mcg

A/Texas/50/2012 (H3N2), NYMC X-223, an A/Victoria/361/2011-like strain, 15 mcg

B Massachusetts/2/2012, NYCM BX-51B, 15 mcg

A/California/7/2009, NYMC X-181 (H1N1), 15 mcg

A/Texas/50/2012, NYCM X-XXX (H3N2), an  A/Victoria/361/2011-like virus, 15 mcg

B Massachusetts/2/2012, BX-XX (B), 15 mcg

A/Christchurch/16/2010 NIB-74XP (H1N1), an A/California/7/2009-like virus, 15 mcg

A/Texas/50/2012 NYMC X-223A (H3N2), an A/Victoria/361/2011-like virus, 15 mcg

B/Massachusetts/2/2012 NYMC BX-51B, 15 mcg

A/Christchurch/16/2010 NIB-74XP (H1N1), an A/California/7/2009-like virus, 15 mcg

A/Victoria/361/2011 IVR-165 (H3N2), 15 mcg

B Massachusetts/2/2012,  NYCM BX-51B, 15 mcg

B/Brisbane/60/2008, 15 mcg

 

A/California/7/2009 (H1N1), 15 mcg

A/Victoria/361/2011 (H3N2), 15 mcg

B/Wisconsin/1/2010, 15 mcg

Excipients (per 0.5 mL dose)

Sodium chloride, 4.1 mg

Monobasic sodium phosphate, 80 mcg

Dibasic sodium phosphate, 300 mcg

Monobasic potassium phosphate, 20 mcg

Potassium chloride, 20 mcg

Calcium chloride, 1.5 mcg

May contain residual amounts of:

Sodium taurodeoxycholate, ≤ 10 ppm

Ovalbumin, ≤1 mcg

Neomycin sulfate, ≤ 3 ng

Polymyxin B, ≤0.5 ng

Beta-propiolactone, ≤2 ng

May contain residual amounts of:

Egg proteins, <0.4 mcg

Formaldehyde, ≤10 mcg

Polysorbate 80, ≤50 mcg

CTAB, ≤12 mcg

Neomycin, ≤0.02 mcg

Kanamycin, ≤0.03 mcg

Barium, <0.5 mcg

Octoxynol-10 (TRITON® X-100), ≤0.085 mg

α-tocopheryl hydrogen succinate, ≤0.1 mg

Polysorbate 80 (Tween 80), ≤0.415 mg

May contain residual amounts of:

Hydrocortisone,  ≤0.0016 mcg

Gentamicin sulfate, ≤0.15 mcg

Ovalbumin, ≤0.05 mcg

Formaldehyde, ≤5 mcg

Sodium deoxycholate, ≤50 mcg

Octoxynol-10 (TRITON® X-100), ≤0.115 mg

α-tocopheryl hydrogen succinate, ≤0.135 mg

Polysorbate 80 (Tween 80), ≤0.550 mg

May contain residual amounts of:

Hydrocortisone,  ≤0.0016 mcg

Gentamicin sulfate, ≤0.15 mcg

Ovalbumin, ≤0.05 mcg

Formaldehyde, ≤5 mcg

Sodium deoxycholate, ≤65mcg

Sodium chloride, 4.4 mg

Monobasic sodium phosphate, 0.195 mcg

Dibasic sodium phosphate, 1.3 mg

Polysorbate 20 (Tween®20), 27.5 mcg

May also contain residual amounts of:

Baculovirus and host cell proteins, ≤28.5 mcg

Cellular DNA, ≤10 ng

Triton X-100, ≤100 mcg

Adjuvant

None

None

None

None

None

Allergens

May contain residual amounts of:

Sodium taurodeoxycholate, ≤ 10 ppm

Ovalbumin, ≤1 mcg

Neomycin sulfate, ≤3 ng

Polymyxin B, ≤0.5 ng

Beta-propiolactone, <2 ng

Thimerosal, 24.5 mcg of mercury [from multi-dose vial]

May contain residual amounts of:

Egg proteins, <0.4 mcg

Formaldehyde, ≤10 mcg

Polysorbate 80, ≤50 mcg

CTAB, ≤12 mcg

Neomycin, ≤0.02 mcg

Kanamycin, ≤0.03 mcg

Latex, may be in syringe tip cap

May contain residual amounts of:

Hydrocortisone,  ≤0.0016 mcg

Gentamicin sulfate, ≤0.15 mcg

Ovalbumin, ≤0.05 mcg

Formaldehyde, ≤5 mcg

Sodium deoxycholate, ≤50 mcg

Natural latex rubber in tip cap of the prefilled syringes

May contain residual amounts of:

Hydrocortisone,  ≤0.0016 mcg

Gentamicin sulfate, ≤0.15 mcg

Ovalbumin, ≤0.05 mcg

Formaldehyde, ≤5 mcg

Sodium deoxycholate, ≤65 mcg

Natural latex rubber in tip cap of the prefilled syringes

 

Preservatives

Single-dose: preservative free

Multi-dose: Thimerosal, 24.5 mcg of mercury

No preservatives

No preservatives

No preservatives

No preservatives

Media

Allantoic fluid of embryonated chicken eggs

Allantoic fluid of embryonated hen eggs

Embryonated chicken eggs

Embryonated chicken eggs

Serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts

Packaging

0.5 mL prefilled single-dose syringe

5 mL (10-dose) multi-dose vial

Prefilled single-dose (0.5 mL) syringe in package of 10

Prefilled syringe (0.5 mL)

Prefilled syringe (0.5 mL)

Prefilled single-dose (0.5 mL) syringe in package of 10

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)

Do not freeze

2 to 8° C (36-46° F)

Do not freeze

Package Insert date

April 2013

Feb 2013

May 2013

May 2013

Dec 2012


 * U.S. ACIP recommends children younger than 9 not receive this vaccine because of an increased risk of febrile seizures in children aged 6 mos - 4 yrs on the day of vaccination to the day after

This page was last updated on February 12, 2014

© 2014 Institute for Vaccine Safety