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.
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). 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.
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). 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.
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). 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.
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). 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.
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). 1
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.
Please see full Prescribing Information for FLUARIX QUADRIVALENT.
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1007203R0 July 2018