FLULAVAL QUADRIVALENT Logo

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

FLULAVAL QUADRIVALENT DOSING & ADMINISTRATION

FLULAVAL QUADRIVALENT is available in1:

  • 0.5 mL single-dose prefilled syringes (package of 10)
  • Thimerosal-free
  • Disposable
  • Packaged without needles
  • CPT code is 906862
FLULAVAL 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 dosea

(0.5 ml)

aOne dose or 2 doses (0.5 mL each), depending on vaccination history, per the annual Advisory Committee on Immunization Practices (ACIP) recommendations 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 Flulaval 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 Flulaval Quadrivalent

  • FLULAVAL 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 light.1

Flulaval Quadrivalent Coding

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

VACCINE CPT CODE 2021 / 2022 NDC CODE 2022 / 2023 NDC CODE ICD-10 CODE
FLULAVAL QUADRIVALENT Package of 10 – Prefilled syringes 90686 Box NDC Code: 19515-818-52
Unit NDC Code: 19515-818-41 
Box NDC Code: 19515-808-52
Unit NDC Code: 19515-808-41
Z23

See CPT, NDC, and ICD-10 codes for FLULAVAL 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

FLULAVAL QUADRIVALENT IMMUNOGENICITY

In clinical trials, FLULAVAL QUADRIVALENT 0.5 mL exhibited immunogenicity noninferior to both quadrivalent and trivalent flu vaccine comparators across a broad age range of patients.1

Children aged 6 through 35 months

In a clinical trial of subjects aged 6 through 35 months, FLULAVAL QUADRIVALENT 0.5 mL exhibited immunogenicity noninferior to the comparator, Fluzone Quadrivalent (Influenza Vaccine) 0.25 mL.1

  • Noninferiority based on adjusted geometric mean titers (GMTs) and seroconversion rates1

Noninferiority of FLULAVAL QUADRIVALENT Relative to a Comparator Quadrivalent Influenza Vaccine at 28 Days Post-vaccination in Children Aged 6 Through 35 Months (According-to-Protocol Cohort for Immunogenicity)1,a,b,c

Adjusted GMTs Against Strains

Adjusted GMTs Against Strain

Seroconversion Ratesf

Seroconversion Rates

CI=confidence interval

  • aTrial 4: NCT02242643.
  • bAccording-to-protocol cohort for immunogenicity included all evaluable subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.
  • cNoninferiority to the comparator vaccine defined as adjusted GMTs with the upper limit of the 2-sided 95% CI for the GMT ratio (comparator/FLULAVAL QUADRIVALENT) ≤1.5 and the seroconversion rates upper limit of the 2-sided 95% CI for the difference between the comparator vaccine and FLULAVAL QUADRIVALENT (comparator minus FLULAVAL QUADRIVALENT) ≤10%.
  • dA 0.5-mL dose containing 15 mcg each of A/California/07/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012 (Yamagata lineage), and B/Brisbane/60/2008 (Victoria lineage).
  • eA 0.25-mL dose of US-licensed quadrivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.) containing 7.5 mcg each of A/California/07/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/02/2012 (Yamagata lineage), and B/Brisbane/60/2008 (Victoria lineage).
  • fSeroconversion defined as a 4-fold increase in post-vaccination antibody titer from pre-vaccination titer ≥1:10, or an increase in titer from <1:10 to ≥1:40.

Study Design

Children aged 3 through 17 years

In a clinical trial in subjects aged 3 through 17 years, FLULAVAL QUADRIVALENT (n=878) exhibited immunogenicity noninferior to two comparator trivalent inactivated influenza vaccine (TIV) formulations, each containing an influenza type B virus that corresponded to one of the two B viruses in FLULAVAL QUADRIVALENT, a type B virus of the Victoria lineage (TIV-1, n=871) or a type B virus of the Yamagata lineage (TIV-2, n=878).

  • Noninferiority was based on adjusted GMTs and seroconversion rates1
  • Seroconversion was defined as a 4-fold increase over baseline in post-vaccination hemagglutination inhibition (HI) antibody titers from pre-vaccination titer ≥1:10, or an increase in titer from <1:10 to ≥1:401

Study Design

Adults aged 18 years and older

In a clinical trial in subjects aged 18 years and older, FLULAVAL QUADRIVALENT (n=1245-1246) exhibited immunogenicity noninferior to two trivalent inactivated influenza vaccine (TIV) fomulations, each containing an influenza type B strain that corresponded to one of the two type B viruses in FLULAVAL QUADRIVALENT (a type B virus of the Victoria lineage (TIV-1, n=204) or a type B virus of the Yamagata lineage (TIV-2, n=210-211))1

  • Noninferiority based on adjusted GMTs

Study Design

FLULAVAL QUADRIVALENT SAFETY

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

Children aged 6 through 35 months

FLULAVAL QUADRIVALENT 0.5 mL demonstrated a safety profile comparable to Fluzone Quadrivalent (Influenza Vaccine) 0.25 mL in a clinical trial.1

FLULAVAL QUADRIVALENT: Incidence of Solicited Local and Systemic Adverse Reactions Within 7 Days of First Vaccination in Children Aged 6 Through 35 Months (Total Vaccinated Cohort)1,a,b

  FLULAVAL QUADRIVALENT 0.5 mL % Fluzone Quadrivalent 0.25 mLc %
  Any Grade 3d Any Grade 3d
Local n=1151 n=1146
Pain 40 2 37 1
Swelling 1 0 0 0
Redness 1 0 1 0
Systemic n=1155 n=1148
Irritability 49 4 46 3
Drowsiness 37 3 37 3
Loss of appetite 29 2 29 1
Fevere 6 1 6 1

Total vaccinated cohort for safety included all vaccinated subjects for whom safety data were available (ie, diary card completed for solicited symptoms). n=number of subjects with diary card completed.

  • aSeven days included day of vaccination and the subsequent 6 days.
  • bTrial 4: NCT02242643.
  • cUS-licensed quadrivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.).
  • dGrade 3 pain: Defined as cried when limb was moved/spontaneously painful. Grade 3 swelling, redness: Defined as >100 mm. Grade 3 irritability: Defined as crying that could not be comforted/prevented normal activity. Grade 3 drowsiness: Defined as prevented normal activity. Grade 3 loss of appetite: Defined as not eating at all. Grade 3 (or higher) fever: Defined as >102.2 °F (39.0 °C).
  • eFever: Defined as ≥100.4 °F (38.0 °C).

In children who received a second dose of FLULAVAL QUADRIVALENT or the comparator vaccine, the incidences of solicited adverse reactions following the second dose were generally similar to or lower than those observed after the first dose.1

Unsolicited adverse events occurring within 28 days of vaccination were reported in 46% and 44% of subjects who received FLULAVAL QUADRIVALENT (n=1207) and the comparator vaccine (n=1217), respectively. The unsolicited adverse reactions that occurred most frequently (≥1%) for FLULAVAL QUADRIVALENT included upper respiratory tract infection, cough, diarrhea, pyrexia, vomiting, and rash. Serious adverse events occurring during the study period (approximately 6 months) were reported in 2% of subjects who received FLULAVAL QUADRIVALENT and in 2% of subjects who received the comparator vaccine.1

Study Design

Children aged 3 through 17 years

FLULAVAL QUADRIVALENT demonstrated a safety profile comparable to two trivalent inactivated influenza vaccines in a clinical trial.1

  • In children who received a second dose of FLULAVAL QUADRIVALENT or either trivalent comparator vaccine, the incidences of adverse reactions following the second dose were generally lower than those observed after the first dose1

Study Design

Adults aged 18 years and older

FLULAVAL QUADRIVALENT demonstrated a safety profile comparable to two trivalent inactivated influenza vaccines in a clinical trial.1

  • Serious adverse events occurring within 21 days of vaccination were reported in 0.4%, 0%, and 0% of subjects who received FLULAVAL QUADRIVALENT, trivalent influenza vaccine (TIV)-1 (B Victoria), or TIV-2 (B Yamagata), respectively1

Study Design

3 ways to order or prebook

Icon: Phone

Call 1-855-475-4QIV (4748)

Icon: Wifi

Online at GSKDirect.com 

Icon: Talk

Contact your GSK Vaccines
Sales Representative