14.2 Efficacy of FLUCELVAX QUADRIVALENT in Children and Adolescents 2 through 17 Years of Age

Absolute efficacy of FLUCELVAX QUADRIVALENT was evaluated in children and adolescents 2 through 17 years of age in Study 2. This was a multinational, randomized, non-influenza vaccine comparator-controlled efficacy, immunogenicity and safety study conducted in 8 countries during the following 3 influenza seasons: Southern Hemisphere 2017, Northern Hemisphere 2017/2018 and Northern Hemisphere 2018/2019. The study enrolled 4514 children and adolescents. Out of the 4514 enrolled, 4513 received either FLUCELVAX QUADRIVALENT (N=2258) or a non-influenza (meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate) comparator vaccine (N=2255). The full analysis set (FAS) for efficacy consisted of 4509 children and adolescents.

Children 2 through 8 years of age received either one or two doses (separated by 4 weeks) of FLUCELVAX QUADRIVALENT or comparator vaccine depending on the subject’s prior influenza vaccination history. Children in the 2-dose comparator group received non-influenza comparator as the first dose and saline placebo as the second dose. Children and adolescents 9 through 17 years of age received a single dose of FLUCELVAX QUADRIVALENT or non-influenza comparator vaccine. Among all enrolled children and adolescents (N=4514), the mean age was 8.8 years, 48% were female, 51% were 2 through 8 years of age, 50% were Caucasian and 49% were Asian. There were no notable differences in the distribution of demographic and baseline characteristics between the two treatment groups.

FLUCELVAX QUADRIVALENT efficacy was assessed by the prevention of confirmed influenza illness caused by any influenza Type A or B strain. Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI) and confirmed by cell culture and/or real-time polymerase chain reaction (RT-PCR). ILI was defined as a fever (oral temperature ≥ 100.0°F / 37.8°C) along with any of the following: cough, sore throat, nasal congestion, or rhinorrhea. The overall vaccine efficacy for the entire study population (2 through 17 years) was 54.6% (95% CI 45.7 – 62.1), which met predefined success criteria. In addition, vaccine efficacy was 50.5% (95% CI 38.4 – 60.2) in children 2 through 8 years of age and 61.9% (95% CI 47.4 – 72.3) in those 9 through 17 years of age. Vaccine efficacy against all influenza viral subtypes and against individual influenza viral subtypes antigenically similar to the subtypes in the vaccine were calculated (Table 6).

Table 6: Efficacy of FLUCELVAX QUADRIVALENT Against First Occurrence RT-PCR Confirmed or Culture Confirmed Influenza in Participants 2 through 17 years of age– FAS Efficacy1 (Study 2).
Number of participants per protocol 1 Number of cases of influenza Attack Rate (%) Vaccine Efficacy (VE) 2
VE % 95% Confidence Interval 3

1 Number of participants in the Full-Analysis Set (FAS) – Efficacy, which included all participants randomized, received a study vaccination and provided efficacy data

2 Efficacy against influenza was evaluated over three influenza seasons, SH 2017, NH 2017-18 and NH 2018-19

3 FLUCELVAX QUADRIVALENT met the pre-defined success criterion defined as the lower limit of the two-sided 95% CI of absolute vaccine efficacy greater than 20%

4 Non-Influenza Comparator: (MENVEO, meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, GlaxoSmithKline Biologicals SA); children assigned to 2 doses received saline placebo as the second dose.

Study 2: NCT03165617

RT-PCR or Culture Confirmed Influenza
FLUCELVAX Quadrivalent 2257 175 7.8 54.6 45.7 — 62.1
Non-Influenza Comparator4 2252 364 16.2
Culture Confirmed Influenza
FLUCELVAX Quadrivalent 2257 115 5.1 60.8 51.3 — 68.5
Non-Influenza Comparator4 2252 279 12.4
Antigenically Matched Culture-Confirmed Influenza
FLUCELVAX Quadrivalent 2257 90 4.0 63.6 53.6 — 71.5
Non-Influenza Comparator4 2252 236 10.5

14.3 Immunogenicity of FLUCELVAX QUADRIVALENT in Adults 18 years of age and above

Immunogenicity of FLUCELVAX QUADRIVALENT was evaluated in adults 18 years of age and older in a randomized, double-blind, controlled study conducted in the US (Study 1). In this study, adults received FLUCELVAX QUADRIVALENT or one of the two formulations of comparator trivalent influenza vaccine (FLUCELVAX QUADRIVALENT (N=1334), TIV1c, N=677 or TIV2c, N=669). In the per protocol set, the mean age of adults who received FLUCELVAX QUADRIVALENT was 57.5 years; 55.1% of adults were female and 76.1% of adults were Caucasian, 13% were black and 9% were Hispanics. The immune response to each of the vaccine antigens was assessed, 21 days after vaccination.

The immunogenicity endpoints were geometric mean antibody titers (GMTs) of hemagglutination inhibition (HI) antibodies response and percentage of adults who achieved seroconversions, defined as a pre-vaccination HI titer of < 1:10 with a post-vaccination titer ≥ 1:40 or a pre-vaccination HI titer > 1:10 and at least 4-fold increase in serum HI antibody titer.

FLUCELVAX QUADRIVALENT was noninferior to TIVc. Noninferiority was established for all 4 influenza strains included in FLUCELVAX QUADRIVALENT, as assessed by ratios of GMTs and the differences in the percentages of adults achieving seroconversion at 3 weeks following vaccination. The antibody response to influenza B strains contained in FLUCELVAX QUADRIVALENT was superior to the antibody response after vaccination with TIVc containing an influenza B strain from the alternate lineage. There was no evidence that the addition of the second influenza B strain resulted in immune interference to other strains included in the vaccine. (See Table 7)

Table 7: Noninferiority of FLUCELVAX QUADRIVALENT relative to TIVc in adults 18 Years of Age and Above– Per Protocol Analysis Set1 (Study 1)

Abbreviations: HI = hemagglutination inhibition. PPS = per protocol set. GMT = geometric mean titer. CI = confidence interval.

1 Per protocol set: All participants in Full Analysis Set, immunogenicity population, who has correctly received the assigned vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/ analysis and are not excluded due to other reasons defined prior to unblinding or analysis.

2 The comparator vaccine for noninferiority comparisons for A/H1N1, A/H3N2 and B1 is TIV1c, for B2 it is TIV2c.

3 Seroconversion rate = percentage of participants with either a pre-vaccination HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a minimum 4-fold increase in post-vaccination HI antibody titer

Study 1: NCT01992094

FLUCELVAX QuadrivalentN = 1250 TIV1c/TIV2c 2 N = 635/N =639 Vaccine Group Ratio(95% CI) Vaccine Group Difference(95% CI)
A/H1N1 GMT(95% CI) 302.8(281.8-325.5) 298.9(270.3-330.5) 1.0(0.9-1.1)
Seroconversion Rate3 (95% CI) 49.2%(46.4-52.0) 48.7%(44.7-52.6) -0.5%(-5.3-4.2)
A/H3N2 GMT(95% CI) 372.3(349.2-396.9) 378.4(345.1-414.8) 1.0(0.9-1.1)
Seroconversion Rate3 (95% CI) 38.3%(35.6-41.1) 35.6%(31.9-39.5) -2.7%(-7.2-1.9)
B1 GMT(95% CI) 133.2(125.3-141.7) 115.6(106.4-125.6) 0.9(0.8-1.0)
Seroconversion Rate3 (95% CI) 36.6%(33.9-39.3) 34.8%(31.1-38.7) -1.8%(-6.2-2.8)
B2 GMT(95% CI) 177.2(167.6-187.5) 164.0(151.4-177.7) 0.9(0.9-1.0)
Seroconversion Rate3 (95% CI) 39.8%(37.0-42.5) 35.4%(31.7-39.2) -4.4%(-8.9-0.2) provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

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