Components of

2018-19 Influenza Vaccines: Quadrivalent

Components Page
Excipients Table
Allergens Table
Name Afluria Quad Fluarix Quad Flublok Quad Flucelvax Quad Flulaval Quad Fluzone Quad
Manufacturer Seqirus GlaxoSmithKline Protein Sciences Seqirus ID Biomedical Corporation of Quebec sanofi pasteur
Viability Inactivated Inactivated Inactivated Inactivated Inactivated
Indicated Ages 6 months and older 6 months and older 18 years and older 4 years and older 6 mos and older 6 mos and older
Dose 0.5 mL 0.5 mL 0.5 mL 0.5 mL 0.5 mL 0.5 mL
Schedule 6-35 mos: 1 or 2 doses depends on vaccination history as per ACIP annual recommendations
36 mos-8 yrs: 1 or 2 doses depends on vaccination history as per ACIP annual recommendations
9 yrs and older: 1 dose
6 mos - 8 yrs: 1 or 2 doses depends on vaccination history as per ACIP annual recommendations. If 2 doses, at least 4 weeks apart.
9 yrs and older: 1 dose
1 dose 4 - 8 yrs: 1 or 2 doses depends on vaccination history as per ACIP annual recommendations. If 2 doses, at least 4 weeks apart.
9 yrs and older: 1 dose
6 mos - 8 yrs: 1 or 2 doses depends on vaccination history as per ACIP annual recommendations. If 2 doses, at least 4 weeks apart.
9 yrs and older: 1 dose
6 mos - 8 yrs: 1 or 2 doses depends on vaccination history as per ACIP annual recommendations. If 2 doses, at least 4 weeks apart.
9 yrs and older: 1 dose
Route Intramuscular Intramuscular Intramuscular - prefer deltoid muscle Intramuscular Intramuscular Intramuscular
Appearance Colorless to slightly opalescent Colorless and slightly opalescent Clear and colorless Slightly opalescent Opalescent, translucent to off-white Clear and slightly opalescent
Concentration • A/Singapore/GP1908 /2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), 15 mcg HA
• A/Singapore/INFIMH-16-0019/2016 IVR-186 (H3N2) (an A/Singapore/INFIMH-16- 399 0019/2016 – like virus), 15 mcg HA
• B/Maryland/15/2016 (a B/Colorado/06/2017 – like virus), 15 mcg HA
• B/Phuket/3073/2013 BVR-1B (a B/Phuket/3073/2013 – like virus), 15 mcg HA
• A/Singapore/GP1908 /2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), 15 mcg HA
• A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, 15 mcg HA
• B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), 15 mcg HA
• B/Phuket/3073/2013, 15 mcg HA
• A/Michigan/45/2015 (H1N1), 45 mcg HA
• A/Singapore/INFIMH-16-0019/2016 (H3N2), 45 mcg HA
• B/Maryland/15/2016 (a B/Colorado/6/2017-like virus), 45 mcg HA
• B/Phuket/3073/2013, 45 mcg
• A/Singapore/GP1908/ 2015 IVR-180 (H1N1) (an A/Michigan/45/2015-like virus), 15 mcg HA
• A/North Carolina/ 04/2016 (H3N2) (an A/Singapore/INFIMH-16-0019/2016 -like virus), 15 mcg HA
• B/Iowa/06/2017 (a B/Colorado/06/2017-like virus), 15 mcg HA
• B/Singapore/INFTT-16-0610/2016 (a B/Phuket/3073/2013-like virus), 15 mcg HA
• A/Singapore/GP1908 /2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), 15 mcg HA
• A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, 15 mcg HA
• B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), 15 mcg HA
• B/Phuket/3073/2013, 15 mcg HA
• A/Michigan/45/2015 X-275 (H1N1), 15 mcg HA
• A/Singaport/INFIMH-10-0019/2016 IVR-186(H3N2), 15 mcg HA
• B/Phuket/3073/2013 (B Yamagata lineage), 15 mcg HA
• B/Maryland/15/2016 BX-69A (a B/Colorado/6/2017-like virus, B Victoria lineage), 15 mcg HA
Preservative Thimerosal, 25 mcg mercury in multi-dose vial
Single-dose: preservative free
None None Thimerosal, 25 mcg mercury in multi-dose vial
Single-dose: preservative free
Thimerosal, 25 mcg mercury in multi-dose vial Thimerosal, 25 mcg mercury in multi-dose vial
Single-dose: preservative free
Adjuvant None None None None None None
Excipients • Sodium chloride, 4.1 mg
• Dibasic sodium phosphate, 300 mcg
• Monobasic sodium phosphate, 80 mcg
• Potassium chloride, 0.02 mg
• Monobasic potassium phosphate, 20 mcg
• Calcium chloride, 0.5 mcg

May also contain trace amounts of:
• Sodium taurodeoxycholate, ≤10 ppm
• Ovalbumin, <1 mcg
• Sucrose, <10 mcg
• Neomycin sulfate, <81.8 ng
• Polymyxin B, <14 ng
• Beta-propiolactone, <1.5 ng
• Octoxynol-10 (TRITON® X-100). ≤0.115 mg
• Beta-tocopheryl hydrogen succinate, ≤0.135 mg
• Polysorbate 80 (Tween 80), ≤0.550 mg

May also contain residual amounts of:
• Hydrocortisone, ≤0.0016 mcg
• Gentamicin sulfate, ≤0.15 mcg
• Ovalbumin, ≤0.050 mcg
• Formaldehyde, ≤5 mcg
• Sodium deoxycholate, ≤65 mcg
• 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:
• Baculovirus and Spodoptera frugiperda cell proteins, ≤ 19 mcg
• Baculovirus and cellular DNA, ≤10 ng
• Triton X-100, ≤100 mcg
May contain residual amounts of:
• MDCK cell protein, ≤8.4 mcg
• Protein other than HA, ≤ 160 mcg
• MDCK cell DNA, ≤ 10 ng
• Polysorbate 80, ≤1500 mcg
• Cetyltrimethly- ammonium bromide, ≤ 18 mcg
• Beta-propiolactone, <0.5 mcg
May contain residual amounts of:
Ovalbumin, ≤0.3 mcg
• Formaldehyde, ≤25 mcg
• Sodium deoxycholate, ≤50 mcg
• Beta-tocopheryl hydrogen succinate, ≤320 mcg
• Polysorbate 80, ≤887 mcg
• Sodium phosphate-buffered isotonic sodium chloride solution, quantity sufficient to volume
• Formaldehyde, ≤100 mcg
• Octylphenol ethoxylate, ≤250 mcg
Allergens • Sodium taurodeoxycholate, ≤10 ppm
• Ovalbumin, <1 mcg
• Neomycin sulfate, <81.8 ng
• Polymyxin B, <14 ng
• Thimerosal, 24.5 mcg in multi-dose only
• Ovalbumin, ≤0.050 mcg
• Gentamicin Sulfate, ≤0.15 mcg
None None • Ovalbumin, ≤0.3 mcg
• Thimerosal, 25 mcg mercury in multi-dose vial only
Thimerosal, 25 mcg mercury in multi-dose vial only
Media Allantoic fluid of embryonated chicken eggs Embryonated chicken eggs Serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts Madin Darby Canine Kidney (MDCK) cells Embryonated chicken eggs
Packaging Pre-filled syringe and Multi-dose vial Syringes in package of 10 Single-dose prefilled syringe Pre-filled syringe and Multi-dose vial Pre-filled syringe and Multi-dose vial Single-dose prefilled syringe without needle (0.25 mL)
Single-dose prefilled syringe without needle (0.5 mL)
Single-dose vial (0.5 ml)
Multi-dose vial (5 mL)
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
2 to 8° C (36-46° F)
Do not freeze
PI date June 2018 June 2018 2018 July 2018 June 2018 June 2018
          table last updated 10/23/18