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).
Rely on the same dose (0.5 mL) for a broad age range of patients, aged 6 months and older.1
Vaccination Dose and Schedule by Age1
|AGED 6 MONTHS THROUGH 8 YEARS||AGED 9 YEARS AND OLDER|
||Not previously vaccinated with influenza vaccine
||Vaccinated with influenza vaccine in a previous season||Not Applicable|
|DOSE AND SCHEDULE||
(0.5 ml each)
at least 4 weeks apart
1 or 2 dosesa
(0.5 ml each)
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
|VACCINE||CPT CODE||2020 / 2021 NDC CODE||2021 / 2022 NDC CODE||ICD-10 CODE|
|FLULAVAL QUADRIVALENT Package of 10 – Prefilled syringes||90686||Box NDC Code: 19515-816-52
Unit NDC Code: 19515-816-41
|Box NDC Code: 19515-818-52
Unit NDC Code: 19515-818-41
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
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
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
- 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.
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
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|
|Loss of appetite||29||2||29||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).