Safety

Children 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)"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

  FLUARIX
QUADRIVALENT
%		 Non-Influenza
Active Comparatorc,d
%
  Any Grade 3e Any Grade 3e
Local n=5,899 n=5,896
Pain 17.2 0.4 17.8 0.5
Redness 13.1 0 14.1 0
Swelling 7.9 0 8.8 0

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

  • a Seven days included day of vaccination and the subsequent 6 days.
  • b Trial 7: NCT01439360.
  • c Children younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.).
  • d 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 (Merck & Co., Inc. or GlaxoSmithKline) (dose 2) for those with no history of influenza vaccination.
  • e Grade 3 pain: Defined as cried when limb was moved/spontaneously painful. Grade 3 swelling, redness: Defined as >50 mm.

Study Design: FLUARIX QUADRIVALENT was studied in a randomized, observer-blind, non-influenza vaccine-controlled efficacy, immunogenicity, and safety trial. The trial included subjects aged 6 through 35 months who received 1 or 2 doses of FLUARIX QUADRIVALENT 0.5-mL (n=6,006) or a non-influenza control vaccine (n=6,012). Solicited local adverse reactions and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

Percentage of patients with solicited systemic adverse events withing 7 daysa after first vaccination in children aged 6 through 35 monthsb (total vacinated cohort)"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

 
FLUARIX
QUADRIVALENT
%		 Non-Influenza
Active Comparatorc,d
%
  Any Grade 3e Any Grade 3e
Systemic n=5,898 n=5,896
Irritability 16.2 0.7 17.5 1.1
Loss of appetite 14.4 1.2 14.8 1
Drowsiness 12.5 0.7 14.1 0.9
Feverf 6.3 1.3 7.2 1.3

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

  • a Seven days included day of vaccination and the subsequent 6 days.
  • b Trial 7: NCT01439360.
  • c Children younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.).
  • d 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 (Merck & Co., Inc. or GSK) (dose 2) for those with no history of influenza vaccination.
  • e 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 drowsiness: Defined as prevented normal activity. Grade 3 fever: Defined as >102.2°F (39.0°C).
  • f Fever: Defined as ≥100.4°F (38.0°C).

Study Design: FLUARIX QUADRIVALENT was studied in a randomized, observer-blind, non-influenza vaccine-controlled efficacy, immunogenicity, and safety trial. The trial included subjects aged 6 through 35 months who received 1 or 2 doses of FLUARIX QUADRIVALENT 0.5-mL (n=6,006) or a non-influenza control vaccine (n=6,012). Solicited local adverse reactions and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

Children 3 through 17 years

Percentage of patients with solicited local adverse reactions within 7 daysa after first vaccination in children aged 3 through 17 yearsb (total vaccinated cohort)"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"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 43.7 1.6 42.4 1.8 40.3 0.8
Redness 23.0 1.0 21.3 0.2 20.9 0.7
Swelling 18.5 0.8 17.2 1.1 14.9 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: FLUARIX QUADRIVALENT was studied in a randomized, double-blind, active-controlled trial. Subjects aged 3 through 17 years received 1 or 2 doses of FLUARIX QUADRIVALENT (n=915) or 1 of 2 formulations of a comparator trivalent influenza vaccine (FLUARIX, TIV-1, n=912 or TIV-2, n=911), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT. Solicited local and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

Percentage of patients with solicited systemic adverse reactions within 7 daysa after first vaccination in children aged 3 through 17 yearsb (total vaccinated cohort)"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"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
Aged 3 through 5 Years
Systemic n=291 n=314 n=279
Drowsiness 17.2 1.0 12.4 0.3 13.6 0.7
Irritability 16.8 0.7 13.4 0.3 14.3 0.7
Loss of appetite 15.5 0.3 8.0 0 10.4 0.7
Feverh 8.9 0.3 8.9 0.3 8.2 1.1
Aged 6 through 17 Years
Systemic n=613 n=588 n=626
Fatigue 19.7 1.5 18.5 1.4 15.5 0.5
Muscle aches 17.5 0.7 16.0 1.4 15.8 0.5
Headache 16.3 1.3 19.2 0.7 15.2 0.6
Arthralgia 9.8 0.3 9.4 0.7 7.3 0.2
Gastrointestinal
symptomsi		 9.8 1.0 9.5 0.7 7.2 0.3
Shivering 6.4 0.5 4.4 0.5 5.0 0
Feverh 6.0 1.1 8.5 0.5 6.1 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.
  • 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.
  • hFever: Defined as ≥99.5°F (37.5°C).
  • iGastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

Study Design: FLUARIX QUADRIVALENT was studied in a randomized, double-blind, active-controlled trial. Subjects aged 3 through 17 years received 1 or 2 doses of FLUARIX QUADRIVALENT (n=915) or 1 of 2 formulations of a comparator trivalent influenza vaccine (FLUARIX, TIV-1, n=912 or TIV-2, n=911), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT. Solicited local and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

Adults

Incidence of solicited local adverse reactions and systemic adverse events within 7 daysa of vaccination in adultsb (total vaccinated cohort)"scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

Trivalent Influenza Vaccine (TIV)
  FLUARIX
QUADRIVALENTc
n=3,011-3,015
%		 TIV-1
(B Victoria)d
n=1,003
%		 TIV-2
(B Yamagata)e
n=607
%
  Any Grade 3f Any Grade 3f Any Grade 3f
Local
Pain 36.4 0.8 36.8 1.2 31.3 0.5
Redness 1.9 0 1.7 0 2.0 0
Swelling 2.1 0 2.1 0 1.3 0
Systemic
Muscle aches 16.4 0.5 19.4 0.8 16.1 0.5
Headache 15.9 0.9 16.4 0.8 13.2 0.7
Fatigue 15.8 0.7 18.4 0.6 14.8 0.5
Arthralgia 8.4 0.5 10.4 0.7 9.4 0.3
Gastrointestinal
symptomsg		 6.5 0.4 6.5 0.2 5.9 0.3
Shivering 4.2 0.4 5.0 0.3 4.3 0.2
Feverh 1.6 0 1.2 0 1.5 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: FLUARIX QUADRIVALENT was studied in a randomized, double-blind, active-controlled, immunogenicity, and safety trial. Subjects aged 18 years and older received FLUARIX QUADRIVALENT (n=3,036) or 1 of 2 formulations of a comparator trivalent influenza vaccine (FLUARIX, TIV-1, n=1,010 or TIV-2, n=610), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT. Solicited local and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days)."scrollbars=yes, resizable=yes, width=400, height=400,top=500, left=500"1

INDICATION

FLUARIX 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. FLUARIX QUADRIVALENT is approved for use in persons aged 6 months and older.

Important Safety Information for FLUARIX QUADRIVALENT

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

Please see full Prescribing Information for FLUARIX QUADRIVALENT.

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FLQWCNT180001 January 2019

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