Vaccine Information: FLUARIX QUADRIVALENT 2019/2020 (Page 4 of 5)

14.2 Immunological Evaluation of FLUARIX QUADRIVALENT in Adults

Trial 1 was a randomized, double-blind (2 arms) and open-label (one arm), active-controlled, safety, immunogenicity, and non-inferiority trial. In this trial, subjects received FLUARIX QUADRIVALENT (n = 1,809) or one of 2 formulations of comparator trivalent influenza vaccine (FLUARIX, TIV-1, n = 608 or TIV-2, n = 534), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Subjects aged 18 years and older (mean age: 58 years) were evaluated for immune responses to each of the vaccine antigens 21 days following vaccination. In the overall population, 57% of subjects were female; 69% were white, 27% were Asian, and 4% were of other racial/ethnic groups.

The immunogenicity endpoints were GMTs of serum HI antibodies adjusted for baseline, and the percentage of subjects who achieved seroconversion, defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4‑fold increase in serum HI antibody titer over baseline to ≥1:40 following vaccination, performed on the According-to-Protocol (ATP) cohort for whom immunogenicity assay results were available after vaccination. FLUARIX QUADRIVALENT was non‑inferior to both TIVs based on adjusted GMTs (upper limit of the 2‑sided 95% CI for the GMT ratio [TIV/FLUARIX QUADRIVALENT] ≤1.5) and seroconversion rates (upper limit of the 2‑sided 95% CI on difference of the TIV minus FLUARIX QUADRIVALENT ≤10%). The antibody response to influenza B strains contained in FLUARIX QUADRIVALENT was higher than the antibody response after vaccination with a TIV containing an influenza B strain from a different lineage. There was no evidence that the addition of the second B strain resulted in immune interference to other strains included in the vaccine (Table 10).

Table 10. FLUARIX QUADRIVALENT: Immune Responses to Each Antigen 21 Days after Vaccination in Adults (ATP Cohort for Immunogenicity)
ATP = According‑to‑protocol; CI = Confidence Interval.ATP cohort for immunogenicity included subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.a Contained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage. b Contained 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).c Contained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza type B virus of Yamagata lineage.d Seroconversion defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum titers of HI antibodies to ≥1:40.

Geometric Mean Antibody Titer

FLUARIX QUADRIVALENTa

Trivalent Influenza Vaccine (TIV)

TIV-1

(B Victoria)b

TIV-2

(B Yamagata)c

n = 1,809

(95% CI)

n = 608

(95% CI)

n = 534

(95% CI)

A/California/7/2009 (H1N1)

201.1

(188.1, 215.1)

218.4

(194.2, 245.6)

213.0

(187.6, 241.9)

A/Victoria/210/2009 (H3N2)

314.7

(296.8, 333.6)

298.2

(268.4, 331.3)

340.4

(304.3, 380.9)

B/Brisbane/60/2008 (Victoria lineage)

404.6

(386.6, 423.4)

393.8

(362.7, 427.6)

258.5

(234.6, 284.8)

B/Brisbane/3/2007 (Yamagata lineage)

601.8

(573.3, 631.6)

386.6

(351.5, 425.3)

582.5

(534.6, 634.7)

Seroconversiond

n = 1,801

%

(95% CI)

n = 605

%

(95% CI)

n = 530

%

(95% CI)

A/California/7/2009 (H1N1)

77.5

(75.5, 79.4)

77.2

(73.6, 80.5)

80.2

(76.5, 83.5)

A/Victoria/210/2009 (H3N2)

71.5

(69.3, 73.5)

65.8

(61.9, 69.6)

70.0

(65.9, 73.9)

B/Brisbane/60/2008 (Victoria lineage)

58.1

(55.8, 60.4)

55.4

(51.3, 59.4)

47.5

(43.2, 51.9)

B/Brisbane/3/2007 (Yamagata lineage)

61.7

(59.5, 64.0)

45.6

(41.6, 49.7)

59.1

(54.7, 63.3)

14.3 Immunological Evaluation of FLUARIX QUADRIVALENT in Children

Trial 7 was a randomized, observer-blind, non-influenza vaccine-controlled trial evaluating the efficacy of FLUARIX QUADRIVALENT. In this trial, subjects aged 6 through 35 months received FLUARIX QUADRIVALENT (n = 6,006) or a non-influenza control vaccine (n = 6,012). Immune responses to each of the vaccine antigens were evaluated in sera 28 days following 1 or 2 doses in a subgroup of subjects (n = 753 for FLUARIX QUADRIVALENT, n = 579 for control in the ATP cohort for immunogenicity).

Immunogenicity endpoints (GMTs and the percentage of subjects who achieved seroconversion) were analyzed based on the ATP cohort for whom immunogenicity assay results were available after vaccination. Antibody responses for all 4 influenza strains are presented in Table 11.

Table 11. FLUARIX QUADRIVALENT: Immune Responses to Each Antigen 28 Days after Last Vaccination in Children Aged 6 through 35 Monthsa (ATP Cohort for Immunogenicity)
ATP = According‑to‑protocol; CI = Confidence Interval.ATP cohort for immunogenicity included subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.a Trial 7: NCT01439360.b Children younger than 12 months: pneumococcal 13-valent conjugate vaccine [Diphtheria CRM197 Protein] (Wyeth Pharmaceuticals, Inc.). c 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 (U.S. Licensed Manufactured by Merck & Co., Inc. or Non-U.S. Licensed Manufactured by GlaxoSmithKline Biologicals) (Dose 2) for those with no history of influenza vaccination.d Seroconversion defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum titers of HI antibodies to ≥1:40.

Geometric Mean Antibody Titer

FLUARIX QUADRIVALENT

Non-Influenza Active Comparatorb,c

n = 750-753

(95% CI)

n = 578-579

(95% CI)

A (H1N1)

165.3

(148.6, 183.8)

12.6

(11.1, 14.3)

A (H3N2)

132.1

(119.1, 146.5)

14.7

(12.9, 16.7)

B (Victoria lineage)

92.6

(82.3, 104.1)

9.2

(8.4, 10.1)

B (Yamagata lineage)

121.4

(110.1, 133.8)

7.6

(7.0, 8.3)

Seroconversiond

n = 742-746

%

(95% CI)

n = 566-568

%

(95% CI)

A (H1N1)

80.2

(77.2, 83.0)

3.5

(2.2, 5.4)

A (H3N2)

68.8

(65.3, 72.1)

4.2

(2.7, 6.2)

B (Victoria lineage)

69.3

(65.8, 72.6)

0.9

(0.3, 2.0)

B (Yamagata lineage)

81.2

(78.2, 84.0)

2.3

(1.2, 3.9)

Trial 2 was a randomized, double-blind, active-controlled, safety, immunogenicity, and non-inferiority trial. In this trial, subjects received FLUARIX QUADRIVALENT (n = 791) or one of 2 formulations of comparator trivalent influenza vaccine (FLUARIX; TIV-1, n = 819; or TIV-2, n = 801), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). In children aged 3 through 17 years, immune responses to each of the vaccine antigens were evaluated in sera 28 days following 1 or 2 doses. In the overall population, 52% of subjects were male; 56% were white, 29% were Asian, 12% were black, and 3% were of other racial/ethnic groups.

The immunogenicity endpoints were GMTs adjusted for baseline, and the percentage of subjects who achieved seroconversion, defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4‑fold increase in serum HI titer over baseline to ≥1:40, following vaccination, performed on the ATP cohort for whom immunogenicity assay results were available after vaccination. FLUARIX QUADRIVALENT was non-inferior to both TIVs based on adjusted GMTs (upper limit of the 2‑sided 95% CI for the GMT ratio [TIV/FLUARIX QUADRIVALENT] ≤1.5) and seroconversion rates (upper limit of the 2‑sided 95% CI on difference of the TIV minus FLUARIX QUADRIVALENT ≤10%). The antibody response to influenza B strains contained in FLUARIX QUADRIVALENT was higher than the antibody response after vaccination with a TIV containing an influenza B strain from a different lineage. There was no evidence that the addition of the second B strain resulted in immune interference to other strains included in the vaccine (Table 12).

Table 12. FLUARIX QUADRIVALENT: Immune Responses to Each Antigen 28 Days after Last Vaccination in Children Aged 3 through 17 Years (ATP Cohort for Immunogenicity)
ATP = According‑to‑protocol; CI = Confidence Interval.ATP cohort for immunogenicity included subjects for whom assay results were available after vaccination for at least one trial vaccine antigen.a Contained the same composition as FLUARIX (trivalent formulation) manufactured for the 2010-2011 season and an additional influenza type B virus of Yamagata lineage.b Contained 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).c Contained the same 2 influenza A subtype viruses as FLUARIX manufactured for the 2010-2011 season and an influenza B virus of Yamagata lineage.d Seroconversion defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥1:40 or at least a 4-fold increase in serum titers of HI antibodies to ≥1:40.

Geometric Mean Antibody Titer

FLUARIX QUADRIVALENTa

Trivalent Influenza Vaccine (TIV)

TIV-1

(B Victoria)b

TIV-2

(B Yamagata)c

n = 791

(95% CI)

n = 818

(95% CI)

n = 801

(95% CI)

A/California/7/2009 (H1N1)

386.2

(357.3, 417.4)

433.2

(401.0, 468.0)

422.3

(390.5, 456.5)

A/Victoria/210/2009 (H3N2)

228.8

(215.0, 243.4)

227.3

(213.3, 242.3)

234.0

(219.1, 249.9)

B/Brisbane/60/2008 (Victoria lineage)

244.2

(227.5, 262.1)

245.6

(229.2, 263.2)

88.4

(81.5, 95.8)

B/Brisbane/3/2007 (Yamagata lineage)

569.6

(533.6, 608.1)

224.7

(207.9, 242.9)

643.3

(603.2, 686.1)

Seroconversiond

n = 790

%

(95% CI)

n = 818

%

(95% CI)

n = 800

%

(95% CI)

A/California/7/2009 (H1N1)

91.4

(89.2, 93.3)

89.9

(87.6, 91.8)

91.6

(89.5, 93.5)

A/Victoria/210/2009 (H3N2)

72.3

(69.0, 75.4)

70.7

(67.4, 73.8)

71.9

(68.6, 75.0)

B/Brisbane/60/2008 (Victoria lineage)

70.0

(66.7, 73.2)

68.5

(65.2, 71.6)

29.6

(26.5, 32.9)

B/Brisbane/3/2007 (Yamagata lineage)

72.5

(69.3, 75.6)

37.0

(33.7, 40.5)

70.8

(67.5, 73.9)

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