Vaccine Information: FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) (Page 4 of 4)

14.4 Immunogenicity in Children and Adolescents 4 through 17 years of age

Immunogenicity of FLUCELVAX QUADRIVALENT was evaluated in children and adolescents 4 through 17 years of age in a randomized, double-blind, controlled study conducted in the US (Study 4). (See section 6.1) In this study, 1159 children and adolescents received FLUCELVAX QUADRIVALENT. In the per protocol set, the mean age of children and adolescents who received FLUCELVAX QUADRIVALENT was 9.8 years; 47% of children and adolescents were female and 54% of children and adolescents were Caucasian, 22% were black and 19% were Hispanics. The immune response to each of the vaccine antigens was assessed, 21 days after vaccination.

The immunogenicity endpoints were the percentage of children and adolescents who achieved seroconversion, defined as a pre-vaccination hemagglutination inhibition (HI) titer of < 1:10 with a post-vaccination HI titer ≥ 1:40 or at least a 4-fold increase in serum HI titer; and percentage of children and adolescents with a post-vaccination HI titer ≥ 1:40.

In children and adolescents receiving FLUCELVAX QUADRIVALENT, for all four influenza strains, the 95% LBCI seroconversion rates were ≥ 40% and the percentage of children and adolescents who achieved HI titer ≥1:40 post vaccination were ≥ 70% (95% LBCI). (See Table 8)

Table 8: The Percentage of Children and Adolescents 4 through 17 years of Age with Seroconversion1 and HI Titers ≥ 1:40 post vaccination with FLUCELVAX QUADRIVALENT– Per-Protocol Analysis Set2 (Study 4)

Abbreviations: HI = hemagglutinin inhibition. CI = confidence interval.

Analyses are performed on data for day 22 for previously vaccinated participants and day 50 for not previously vaccinated participants.

1 Seroconversion rate = percentage of participants with either a pre-vaccination HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a minimum 4-fold increase in post-vaccination HI titer. Immunogenicity success criteria were met if the lower limit of the 95% confidence interval (CI) of the percentage of participants with HI titer ≥ 1:40 is ≥ 70%; and the lower limit of the 95% CI of the percentage of participants with seroconversion is ≥ 40%.

2 Per protocol set: All participants in Full Analysis Set, immunogenicity population, who has correctly received the assigned vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/ analysis and are not excluded due to other reasons defined prior to unblinding or analysis.

Study 4: NCT 01992107

A/H1N1N = 1014 A/H3N2 N = 1013 B1N = 1013 B2N = 1009
Seroconversion Rate 1 (95% CI) 72% (69-75) 47% (44-50) 66% (63-69) 73% (70-76)
HI titer ≥1:40 99% (98-100) 100% (99-100) 92% (91-94) 91% (89-93)

15 REFERENCES

  1. Lasky T, Terracciano GJ, Magder L, et al. The Guillain-Barré syndrome and the 1992-1993 and 1993-1994 influenza vaccines. N Engl J Med 1998; 339(25):1797-1802.
  2. Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004; 103:133-138.
  3. Hobson D, Curry RL, Beare A, et al. The role of serum hemagglutinin-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972; 767-777.
  4. Centers for Disease Control and Prevention. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011; 60(33): 1128-1132

16 HOW SUPPLIED/STORAGE AND HANDLING

FLUCELVAX QUADRIVALENT product presentations are listed in Table 9 below:

Table 9: Flucelvax Product Presentations
Presentation Carton NDC Number Components
Pre-filled Syringe 70461-320-03 0.5 mL single dose pre-filled syringe, package of 10 syringes per carton [NDC 70461-320-04]
Multi-dose Vial 70461-420-10 5 mL multi-dose vial, individually packaged in a carton [NDC 70461-420-11]

Store this product refrigerated at 2°C to 8°C (36ºF to 46ºF). Between uses, return the multi-dose vial to the recommended storage conditions. Do not freeze. Protect from light. Do not use after the expiration date.

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipients of the potential benefits and risks of immunization with FLUCELVAX QUADRIVALENT.

Educate vaccine recipients regarding the potential side effects; clinicians should emphasize that (1) FLUCELVAX QUADRIVALENT contains non-infectious particles and cannot cause influenza and (2) FLUCELVAX QUADRIVALENT is intended to provide protection against illness due to influenza viruses only and cannot provide protection against other respiratory illnesses.

Instruct vaccine recipients to report adverse reactions to their healthcare provider.

Provide vaccine recipients with the Vaccine Information Statements which are required by the National Childhood Vaccine Injury Act of 1986. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Inform vaccine recipients that annual vaccination is recommended.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

Manufactured by: Seqirus Inc. Holly Springs, NC 27540, USA

US License No. 2049

Distributed by: Seqirus USA Inc. 25 Deforest Avenue, Summit, NJ 07901, USA

1-855-358-8966

Principal Display Panel — Flucelvax Quadrivalent Injection Suspension 2020-2021 0.5 mL Syringe Label

Influenza Vaccine

FLUCELVAX ® QUADRIVALENT

2020 – 2021 Formula

NDC 70461-320-04

Principal Display Panel -- Flucelvax Quadrivalent Injection Suspension 2020-2021 0.5 mL Syringe Label
(click image for full-size original)

Principal Display Panel — Flucelvax Quadrivalent Injection Suspension 2020-2021 0.5 mL Carton Label

NDC 70461-320-03

For use in persons 2 years of age and older

For Intramuscular Injection Only

Ten 0.5 mL, single-dose, pre-filled syringes

Rx Only

Influenza Vaccine

FLUCELVAX ®

QUADRIVALENT

2020-2021 FORMULA

Principal Display Panel -- Flucelvax Quadrivalent Injection Suspension 2020-2021 0.5 mL Carton Label
(click image for full-size original)

Principal Display Panel — Flucelvax Quadrivalent Injection Suspension 2020-2021 5 mL Multi-dose Vial Label

NDC 70461-420-11

Influenza Vaccine

FLUCELVAX ®

QUADRIVALENT

2020-2021 Formula

5mL vial

Principal Display Panel -- Flucelvax Quadrivalent Injection Suspension 2020-2021 5 mL Multi-dose Vial Label
(click image for full-size original)

Principal Display Panel — Flucelvax Quadrivalent Injection Suspension 2020-2021 5 mL Carton Label

NDC 70461-420-10

5 mL vial

Rx Only

Seqirus™

For use in persons 2 years of age and older

For Intramuscular Injection Only

Influenza Vaccine

FLUCELVAX ®

QUADRIVALENT

2020-2021 Formula

Principal Display Panel -- Flucelvax Quadrivalent Injection Suspension 2020-2021 5 mL Carton Label
(click image for full-size original)
FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) influenza a virus a/nebraska/14/2019 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/delaware/39/2019 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/darwin/7/2019 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:70461-320
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/DARWIN/7/2019 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM CHLORIDE
SODIUM CHLORIDE
MAGNESIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70461-320-03 10 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS (70461-320-04)
1 NDC:70461-320-04 0.5 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (70461-320-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125408 07/02/2020 07/31/2021
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) influenza a virus a/nebraska/14/2019 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/delaware/39/2019 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/darwin/7/2019 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:70461-420
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/NEBRASKA/14/2019 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA A VIRUS A/DELAWARE/39/2019 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (INFLUENZA B VIRUS B/DARWIN/7/2019 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)) INFLUENZA B VIRUS B/DARWIN/7/2019 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POTASSIUM CHLORIDE
SODIUM CHLORIDE
MAGNESIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
THIMEROSAL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70461-420-10 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE (70461-420-11)
1 NDC:70461-420-11 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (70461-420-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125408 07/02/2020 07/31/2021
Labeler — Seqirus Inc. (080102141)
Establishment
Name Address ID/FEI Operations
Seqirus Inc. 080102141 API MANUFACTURE, MANUFACTURE, LABEL, PACK, ANALYSIS

Revised: 03/2021 Seqirus Inc.

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