FLUARIX QUADRIVALENT Logo

Rely on the same dose (0.5 mL) for a broad age range of patients, aged 6 months and older.1

FLUARIX QUADRIVALENT DOSING & ADMINISTRATION

FLUARIX QUADRIVALENT is available in1:

  • 0.5 mL single-dose prefilled syringes (package of 10)
  • Thimerosal-free
  • Disposable
  • Packaged without needles
  • CPT code is 906862
FLUARIX QUADRIVALENT Vaccination Dose

Vaccination Dose and Schedule by Age1

  AGED 6 MONTHS THROUGH 8 YEARS AGED 9 YEARS AND OLDER
VACCINATION STATUS
Not previously vaccinated with influenza vaccine
Vaccinated with influenza vaccine in a previous season Not Applicable
DOSE AND SCHEDULE

2 doses

(0.5 ml each)

at least 4 weeks apart

1 or 2 dosesa

(0.5 ml each)

1 dose

(0.5 ml)

aOne dose or 2 doses (0.5 mL each) depending on vaccination history as per the annual Advisory Committee on Immunization Practices (ACIP) recommendation on prevention and control of influenza with vaccines. If 2 doses, administer each 0.5-mL dose at least 4 weeks apart.

Icon: Vaccination

Administering Fluarix Quadrivalent

  • The preferred sites for intramuscular injection are the anterolateral thigh for children aged 6 through 11 months and the deltoid muscle of the upper arm for persons aged 12 months and older1
  • Do not administer this product intravenously, intradermally, or subcutaneously1
Icon: Storage

Storing Fluarix Quadrivalent

  • FLUARIX QUADRIVALENT should be refrigerated between 36 °F and 46 °F (2 °C and 8 °C). Do not freeze. Discard if the vaccine has been frozen. Store in the original package to protect from light1

Fluarix Quadrivalent Coding

CPT, NDC, and ICD-10 Codes for FLUARIX QUADRIVALENT

VACCINE CPT CODE 2020 / 2021 NDC CODE 2021 / 2022 NDC CODE ICD-10 CODE
FLUARIX QUADRIVALENT Package of 10 – Prefilled syringes 90686 Box NDC Code: 58160-885-52
Unit NDC Code: 58160-885-41 
Box NDC Code: 58160-887-52
Unit NDC Code: 58160-887-41
Z23

See CPT, NDC, and ICD-10 codes for FLUARIX QUADRIVALENT.

Please refer to your most up-to-date Current Procedural Terminology (CPT) and International Classification of Diseases (ICD) manuals for appropriate coding.

Administration codes will vary based on the service provided.

Prefilled syringe includes:

  • Color-coding and color band for easy and quick identification
  • 2-D bar code with the NDC numbers, lot number, and expiration date to help simplify the documentation process

More information about coding

FLUARIX QUADRIVALENT EFFICACY AND IMMUNOGENICITY

In clinical trials, FLUARIX QUADRIVALENT (N = 6,006) exhibited efficacy and immunogenicity in children aged 6 to 35 months compared to a non-influenza active comparator (N = 6,012). FLUARIX QUADRIVALENT exhibited noninferior immunogenicity in children aged 3 through 17 years and adults aged 18 years and older, when compared to trivalent flu vaccine comparators.1

Children aged 6 through 35 months

FLUARIX QUADRIVALENT was evaluated for efficacy and immunogenicity in a randomized, observer-blinded, non-influenza vaccine comparator, controlled trial conducted to evaluate the prevention of any or moderate to severe reverse transcriptase polymerase chain reaction-confirmed influenza-like illness in children aged 6 to 35 months (N=12,018).1

Vaccine Efficacy Against Influenza A and/or B in Children Aged 6 Through 35 Monthsa (ATP Cohort for Efficacy–Time to Event)1

  Nb nc Vaccine Efficacy % (97.5% CI)
All RT-PCR-confirmed influenza
FLUARIX QUADRIVALENT 5707 344
49.8 (41.8d, 56.8)
Non-influenza comparatore,f 5697 662
  Nb nc Vaccine Efficacy % (95% CI)
All culture-confirmed influenza
FLUARIX QUADRIVALENT 5707 303 51.2 (44.1g, 57.6)
Non-influenza comparatore,f 5697 602
All antigenically matched culture-confirmed influenza
FLUARIX QUADRIVALENT 5707 88 60.1 (49.1h, 69.0)
Non-influenza comparatore,f 5697 216

ATP=According-to-Protocol; CI=confidence interval; RT-PCR=Reverse Transcriptase Polymerase Chain Reaction.

  • aTrial 7: NCT01439360.
  • bNumber of subjects in the ATP cohort for efficacy–time to event, which included subjects who met all eligibility criteria, who were followed for efficacy and complied with the study protocol until the influenza-like episode.
  • cNumber of subjects who reported at least one case in the reporting period.
  • dVaccine efficacy for FLUARIX QUADRIVALENT met the pre-defined criterion for the lower limit of the 2-sided 97.5% CI (>15% for all influenza).
  • eChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.).
  • f Children 12 months and older: HAVRIX (Hepatitis A Vaccine) for those with a history of influenza vaccination; or HAVRIX (Dose 1) and a varicella vaccine (U.S. Licensed Manufactured by Merck & Co., Inc. or Non-U.S. Licensed Manufactured by GlaxoSmithKline Biologicals) (Dose 2) for those with no history of influenza vaccination.
  • gVaccine efficacy for FLUARIX QUADRIVALENT met the pre-defined criterion of >10% for the lower limit of the 2-sided 95% CI.
  • hVaccine efficacy for FLUARIX QUADRIVALENT met the pre-defined criterion of >15% for the lower limit of the 2-sided 95% CI.

Study Design

The vaccine efficacy against RT-PCR-confirmed influenza associated with adverse outcomes was 64.6% (97.5% CI 53.2%, 73.5%). The vaccine efficacy against RT-PCR-confirmed influenza associated with adverse outcomes due to A/H1N1, A/H3N2, B/Victoria, and B/Yamagata was 71.4% (95% CI 48.5%, 85.2%), 51.3% (95% CI 32.7%, 65.2%), 86.7% (95% CI 52.8%, 97.9%), and 68.9% (95% CI 50.6%, 81.2%), respectively.1

For RT-PCR-confirmed influenza cases associated with adverse outcomes, the incidence of the specified adverse outcomes is presented in the table below.

Incidence of Adverse Outcomes Associated with RT-PCR-Positive Influenza in Children Aged 6 Through 35 Monthsa (ATP Cohort for Efficacy–Time to Event)1,b

Influenza-Associated Symptome FLUARIX QUADRIVALENT n=5707 Non-Influenza Active Comparatorc,d n=5697
Number of events Number of subjectsf % Number of events Number of subjectsf %
Fever >102.2 ⁰F/39 ⁰C 62 61 1.1 184 183 3.2
Acute otitis media (AOM)g 5 5 0.1 15 15 0.3
Physician-diagnosed lower respiratory tract illnessh 28 28 0.5 62 61 1.1
Physician-diagnosed serious extra-pulmonary complicationsi 2 2 0 3 3 0.1
Hospitalization in the intensive care unit 0 0 0 0 0 0
Suplemental oxygen required for more than 8 hours 0 0 0 0 0 0

ATP=According-to-Protocol; RT-PCR=Reverse transcriptase polymerase chain reaction.

  • aTrial 7: NCT01439360.
  • bNumber of subjects in the ATP cohort for efficacy–time to event, which included subjects who met all eligibility criteria, who were followed for efficacy and complied with the study protocol until the influenza-like episode.
  • cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.).
  • dChildren 12 months and older: HAVRIX (Hepatitis A Vaccine) for those with a history of influenza vaccination; or HAVRIX (Dose 1) and a varicella vaccine (U.S. Licensed Manufactured by Merck & Co., Inc. or Non-U.S. Licensed Manufactured by GlaxoSmithKline Biologicals) (Dose 2) for those with no history of influenza vaccination.
  • eSubjects who experienced more than one adverse outcome, each outcome was counted in the respective category.
  • fNumber of subjects with at least one event in a given category.
  • gAnalyses considered AOM cases confirmed by otoscopy.
  • hPneumonia, lower respiratory tract infection, bronchiolitis, bronchitis, or croup infection as per final diagnosis by physician.
  • iIncludes myositis, encephalitis or other neurologic condition including seizure, myocarditis/pericarditis or other serious medical condition as per final diagnosis by physician.

Study Design

Immunogenicity

  • Immunogenicity was evaluated in comparison to a non-influenza active comparator vaccine in a clinical trial1
    • Immunogenicity was based on geometric mean titers and seroconversion rates (defined as the percentage of vaccinees with a pre-vaccination hemagglutination-inhibition [HI] titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum titers of HI antibodies to ≥1:40)

FLUARIX QUADRIVALENT: Immune Responses to Each Antigen 28 Days After Last Vaccination in Children Aged 6 Through 35 Months (ATP Cohort for Immunogenicity)1,a

Chart showing FLUARIX QUADRIVALENT: Immune Responses to Each Antigen 28 Days After Last Vaccination in Children Aged 6 Through 35 Months (According-to-Protocol Cohort for Immunogenicity)

aNote: For comparison of the non-influenza controls (gray) in the bar graph, please use the appropriate Y-axis scale corresponding to either FLUARIX QUADRIVALENT GMTs (green) or seroconversion rates (orange).

ATP=According-to-Protocol; CI=confidence interval.

 

ATP cohort for immunogenicity included subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.

  • Trial 7: NCT01439360.
  • Children younger than 12 months received pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.).
  • Children 12 months and older received HAVRIX (Hepatitis A Vaccine) for those with a history of influenza vaccination; or HAVRIX (Dose 1) and a varicella vaccine (U.S. Licensed Manufactured by Merck & Co., Inc. or Non-U.S. Licensed Manufactured by GlaxoSmithKline Biologicals) (Dose 2) for those with no history of influenza vaccination.

Study Design

Children aged 3 through 17 years

FLUARIX QUADRIVALENT exhibited immunogenicity non-inferior to two trivalent inactivated influenza vaccines in a randomized, double-blind, active-controlled, safety, immunogenicity, and non-inferiority clinical trial.1

  • Non-inferiority was based on adjusted GMTs and seroconversion rates
  • Seroconversion was defined as a pre-vaccination hemagglutination-inhibition (HI) titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum HI titer over baseline to ≥1:401

Study Design

Adults aged 18 years and older

FLUARIX QUADRIVALENT exhibited immunogenicity non-inferior to two trivalent inactivated influenza vaccines in an open-label (one arm), active-controlled, safety, immunogenicity, and non-inferiority clinical trial.1

  • Non-inferiority based on adjusted GMTs and seroconversion rates
  • Seroconversion was defined as a pre-vaccination hemagglutination-inhibition (HI) titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum HI titer over baseline to ≥1:401

Study Design

GMTs=geometric mean titers.

FLUARIX QUADRIVALENT SAFETY

In clinical trials, FLUARIX QUADRIVALENT 0.5 mL demonstrated a safety profile comparable to trivalent flu vaccines across a broad age range of patients.1

Children aged 6 through 35 months

Percentage of Patients With Solicited Local Adverse Reactions Within 7 daysa After First Vaccination in Children aged 6 Through 35 Monthsb (Total Vaccinated Cohort)1

  FLUARIX CUADRIVALENT % Non-Influenza Active Comparatorc,d %
  Any Grade 3e Any Grade 3e
Local n=5899 n=5896
Pain 17 0.4 18 0.5
Redness 13 0 14 0
Swelling 8 0 9 0

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available.

  • aSeven days included day of vaccination and the subsequent 6 days.
  • bTrial 7: NCT01439360.
  • cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.).
  • dChildren 12 months and older: HAVRIX (Hepatitis A Vaccine) for those with a history of influenza vaccination; or HAVRIX (dose 1) and a varicella vaccine (Merck & Co., Inc. [US Subjects] or GlaxoSmithKline [non-US Subjects]) (dose 2) for those with no history of influenza vaccination.
  • eGrade 3 pain: Defined as cried when limb was moved/spontaneously painful. Grade 3 swelling, redness: Defined as >50 mm.

Study Design

Percentage of Patients With Solicited Systemic Adverse Events Within 7 Daysa After First Vaccination in Children Aged 6 Through 35 Monthsb (Total Vaccinated Cohort)1

  FLUARIX CUADRIVALENT % Non-Influenza Active Comparatorc,d %
  Any Grade 3e Any Grade 3e
Systemic n=5898 n=5896
Irritability 16 0.7 18 1
Loss of appetite 14 1 15 1
Drowsiness 13 0.7 14 0.9
Feverf 6 1 7 1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n=Number of subjects with diary card completed.

  • aSeven days included day of vaccination and the subsequent 6 days.
  • bTrial 7: NCT01439360.
  • cChildren younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.).
  • dChildren 12 months and older: HAVRIX (Hepatitis A Vaccine) for those with a history of influenza vaccination; or HAVRIX (dose 1) and a varicella vaccine (Merck & Co., Inc. [US Subjects] or GlaxoSmithKline Biologicals [non-US Subjects]) (dose 2) for those with no history of influenza vaccination.
  • eGrade 3 irritability: Defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite: Defined as not eating at all. Grade 3 drowsiness: Defined as prevented normal activity. Grade 3 fever: Defined as >102.2 °F (39.0 °C). Fever: Defined as ≥100.4 °F (38.0 °C).
  • fFever: Defined as ≥100.4

Study Design

Children aged 3 through 17 years

Percentage of Patients With Solicited Local Adverse Reactions Within 7 Daysa After First Vaccination in Children Aged 3 Through 17b Years (Total Vaccinated Cohort)1

      Trivalent Influenza Vaccine (TIV)
  FLUARIX QUADRIVALENTc % TIV-1 (B Victoria)d % TIV-2 (B Yamagata)e %
  Any Grade 3f Any Grade 3f Any Grade 3f
Local n=903 n=901 n=905
Paing 44 2 42 2 40 0.8
Redness 23 1 21 0.2 21 0.7
Swelling 19 0.8 17 1 15 0.2

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n=number of subjects with diary card completed.

  • aSeven days included day of vaccination and the subsequent 6 days.
  • bTrial 2: NCT01196988.
  • cContained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
  • dContained the same composition as FLUARIX manufactured for the 2010-2011 season (2 influenza A subtype viruses and an influenza type B virus of Victoria lineage).
  • eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
  • fGrade 3 pain: Defined as cried when limb was moved/spontaneously painful (children <6 years), or significant pain at rest, prevented normal everyday activities (children ≥6 years). Grade 3 redness, swelling: Defined as >50 mm.
  • gPercentage of subjects with any pain by age subgroup: 39%, 38%, and 37% for FLUARIX QUADRIVALENT, TIV-1, and TIV-2, respectively, in children aged 3 through 8 years and 52%, 50%, and 46% for FLUARIX QUADRIVALENT, TIV-1, and TIV-2, respectively, in children aged 9 through 17 years.

Study Design

Percentage of Patients With Solicited Systemic Adverse Reactions Within 7 Daysa After First Vaccination in Children Aged 3 Through 17 Yearsb (Total Vaccinated Cohort)1

      Trivalent Influenza Vaccine (TIV)
  FLUARIX QUADRIVALENTc % TIV-1 (B Victoria)d % TIV-2 (B Yamagata)e %
  Any Grade 3f Any Grade 3f Any Grade 3f
Age 3 through 5 years
Systemic n=291 n=314 n=279
Drowsiness 17 1 12 0.3 14 0.7
Irritability 17 0.7 13 0.3 14 0.7
Loss of appetite 16 0.3 8 0 10 0.7
Feverg 9 0.3 9 0.3 8 1
Age 6 through 17 years
Systemic n=613 n=588 n=626
Fatigue 20 2 19 1 16 0.5
Muscle aches 18 0.7 16 1 16 0.5
Headache 16 1 19 0.7 15 0.6
Arthralgia 10 0.3 9 0.7 7 0.2
Gastrointestinal symptomsh 10 1 10 0.7 7 0.3
Shivering 6 0.5 4 0.5 5 0
Feverg 6 1 9 0.5 6 0.3

Total vaccinated cohort for safety included all subjects for whom safety data were available. n=number of subjects with diary card completed.

  • aSeven days included day of vaccination and the subsequent 6 days.
  • bTrial 2: NCT01196988.
  • cContained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
  • dContained the same composition as FLUARIX manufactured for the 2010-2011 season (2 influenza A subtype viruses and an influenza type B virus of Victoria lineage).
  • eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
  • fGrade 3 drowsiness: Defined as prevented normal activity. Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite: Defined as not eating at all. Grade 3 fever: Defined as >102.2 °F (39.0 °C). Grade 3 fatigue, muscle aches, headache, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity.
  • gFever: Defined as ≥99.5 °F (37.5 °C).
  • hGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

Study Design

Adults aged 18 years and older

Incidence of Solicited Local Adverse Reactions and Systemic Adverse Reactions Within 7 Daysa of Vaccination in Adultsb (Total Vaccinated Cohort)1

      Trivalent Influenza Vaccine (TIV)
  FLUARIX QUADRIVALENTc n=3011-3015 % TIV-1 (B Victoria)d n=1003 % TIV-2 (B Yamagata)e n=607 %
  Any Grade 3f Any Grade 3f Any Grade 3f
Local  
Pain 36 0.8 37 1 31 0.5
Redness 2 0 2 0 2 0
Swelling 2 0 2 0 1 0
Systemic  
Muscle aches 16 0.5 19 0.8 16 0.5
Headache 16 0.9 16 0.8 13 0.7
Fatigue 16 0.7 18 0.6 15 0.5
Arthralgia 8 0.5 10 0.7 9 0.3
Gastrointestinal symptomsg 7 0.4 7 0.2 6 0.3
Shivering 4 0.4 5 0.3 4 0.2
Feverh 2 0 1 0 2 0

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available. n=number of subjects with diary card completed.

  • aSeven days included day of vaccination and the subsequent 6 days.
  • bTrial 1: NCT01204671.
  • cContained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.
  • dContained the same composition as FLUARIX manufactured for the 2010-2011 season (2 influenza A subtype viruses and an influenza type B virus of Victoria lineage).
  • eContained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.
  • fGrade 3 pain: Defined as significant pain at rest; prevented normal everyday activities. Grade 3 redness, swelling: Defined as >100 mm. Grade 3 muscle aches, headache, fatigue, arthralgia, gastrointestinal symptoms, shivering: Defined as prevented normal activity. Grade 3 fever: Defined as >102.2 °F (39.0 °C).
  • gGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
  • hFever: Defined as ≥99.5 °F (37.5 °C).

Study Design

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