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 Adverse Reactions and Systemic Adverse Events Within 7 Days of First Vaccination in Children Aged 6 Through 35 Months (Total Vaccinated Cohort)1,*,†

  FLULAVAL QUADRIVALENT 0.5-mL
%
Fluzone Quadrivalent 0.25-mL
%
Any Grade 3§ Any Grade 3§
Local Adverse Events n=1,151 n=1,146
Pain 40.3 2.4 37.4 1.4
Swelling 1.0 0.0 0.4 0.0
Redness 1.3 0.0 1.3 0.0
Systemic Adverse Events n=1,155 n=1,148
Irritability 49.4 3.8 45.9 3.0
Drowsiness 36.7 2.7 36.9 2.6
Loss of Appetite 28.9 1.6 28.6 1.3
Fever|| 5.6 1.4 5.8 1.0

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.

* 7 days included day of vaccination and the subsequent 6 days.
Trial 4: NCT02242643.
US-licensed quadrivalent, inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.).
§ Grade 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).
|| Fever: 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 events 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=1,207) and the comparator vaccine (n=1,217), 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

FLULAVAL QUADRIVALENT was studied in a randomized, observer-blind. active-controlled immunogenicity and safety trial. The trial included subjects aged 6 through 35 months who received 1 or 2 doses of FLULAVAL QUADRIVAlENT 0.5-mL (n=1,207) or Fluzone Quadrivalent 0.25-mL (n=1,217), depending on vaccination history. Subjects were followed for safety for 6 months; solicited local adverse reactions and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days).1

Information on Fever in Pediatric Patients at 0.5-mL Dose

FLULAVAL is a registered trademark of the GSK group of companies.
Fluzone is a registered trademark of Sanofi Pasteur Inc.

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, the incidences of adverse events following the second dose were generally lower than those observed after the first dose1

Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, double-blind, active-controlled trial. Subjects aged 3 through 17 years received FLULAVAL QUADRIVALENT or 1 of 2 formulations of a comparator trivalent influenza vaccine. Children aged 3 through 8 years received 1 or 2 doses, depending on vaccination history. Children aged 9 years and older received 1 dose. Solicited local adverse reactions and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days).1

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, TIV-1 (B Victoria), or TIV-2 (B Yamagata), respectively1

Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, double-blind, active-controlled immunogenicity and safety trial. Subjects aged 18 years and older received FLULAVAL QUADRIVALENT or 1 of 2 formulations of a comparator trivalent influenza vaccine. Solicited adverse events were collected for 7 days (day of vaccination and the next 6 days).1

FLULAVAL is a registered trademark of the GSK group of companies.

Indication

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

Important Safety Information for FLULAVAL QUADRIVALENT

  • Do not administer 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 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 FLULAVAL QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • If 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 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 FLULAVAL QUADRIVALENT may not result in protection in all vaccine recipients

Please see full Prescribing Information for FLULAVAL QUADRIVALENT.

View all references.

 

819254R0 September 2017