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

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

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.

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

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

Coding

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

VACCINE	CPT CODE	2022-2023 NDC NUMBER	2023-2024 NDC NUMBER	ICD-10 CODE
FLULAVAL QUADRIVALENT Package of 10 – Prefilled syringes	90686	Box NDC Code: 19515-808-52 Unit NDC Code: 19515-808-41	Box NDC Code: 19515-814-52 Unit NDC Code: 19515-814-41	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

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

Children aged 3 through 17 years

Adults aged 18 years and older

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 Postvaccination in Children Aged 6 Through 35 Months (According-to-Protocol Cohort for Immunogenicity)^1,a,b,c

Adjusted GMTs Against Strains

Seroconversion Rates^f

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 GMTs1

Study Design

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

Children aged 3 through 17 years

Adults aged 18 years and older

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

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

Online at GSKDirect.com

Contact your GSK Vaccines
Sales Representative

Indication & Important Safety Info

Indication for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT

FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccines. FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT are approved for use in persons aged 6 months and older.

Important Safety Information for FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT

Do not administer FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine

Do not administer FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine

Do not administer FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT should be based on careful consideration of the potential benefits and risks
Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX QUADRIVALENT and FLULAVAL QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
If FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons
In clinical trials with FLUARIX QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common systemic adverse reactions were muscle aches, headache, and fatigue. In children 6 through 35 months of age, the most common solicited local adverse reactions were pain and redness and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children 3 through 17 years of age, the solicited local adverse reactions were pain, redness, and swelling. In children 3 through 5 years of age, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite. In children 6 through 17 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLUARIX QUADRIVALENT for other potential adverse reactions and events)
In clinical trials with FLULAVAL QUADRIVALENT in adults, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were muscle aches, headache, fatigue, and arthralgia. In children 6 through 35 months of age, the most common solicited local adverse reaction was pain and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 3 through 17 years of age, the most common solicited local adverse reaction was pain. In children 3 through 4 years of age, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children 5 through 17 years of age, the most common solicited systemic adverse reactions were muscle aches, fatigue, headache, arthralgia, and gastrointestinal symptoms. (See Adverse Reactions section of the Prescribing Information for FLULAVAL QUADRIVALENT for other potential adverse reactions and events)
Vaccination with FLUARIX QUADRIVALENT or FLULAVAL QUADRIVALENT may not result in protection in all vaccine recipients

Please see full Prescribing Information for FLUARIX QUADRIVALENT.

Please see full Prescribing Information for FLULAVAL QUADRIVALENT.

View References

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DOSING & ADMINISTRATION

Vaccination Dose and Schedule by Age1

Administering Flulaval Quadrivalent

Storing Flulaval Quadrivalent

Coding

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

Prefilled syringe includes:

IMMUNOGENICITY

Children aged 6 through 35 months

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

Adjusted GMTs Against Strains

Seroconversion Ratesf

Children aged 3 through 17 years

Adults aged 18 years and older

SAFETY

Children aged 6 through 35 months

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

Children aged 3 through 17 years

Adults aged 18 years and older

3 ways to order or prebook

GSK Vaccines Access Program

Vaccination Dose and Schedule by Age¹

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

Seroconversion Rates^f

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