Flucelvax Quadrivalent 2018-2019 Formula

Name: Flucelvax Quadrivalent 2018-2019 Formula

Indications

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older. For children and adolescents 4 through 17 years of age, approval is based on the immune response elicited by FLUCELVAX QUADRIVALENT. Data demonstrating a decrease in influenza disease after vaccination of this age group with FLUCELVAX QUADRIVALENT are not available. [see Clinical Studies]

Warnings

Included as part of the "PRECAUTIONS" Section

Clinical pharmacology

Mechanism Of Action

Influenza illness and its complications follow infection with influenza viruses. Global surveillance and analysis of influenza virus isolates permits identification of yearly antigenic variants. Since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Specific levels of hemagglutination inhibition (HI) antibody titers induced by vaccination with inactivated influenza virus vaccine have not been correlated with protection from influenza illness. In some studies, HI antibody titers of ≥1:40 have been associated with protection from influenza illness in up to 50% of subjects.2,3

Antibody against one influenza virus type or subtype confers little or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more strains in each year’s influenza vaccine. Therefore, inactivated influenza vaccines are standardized to contain the hemagglutinin of influenza virus strains representing the influenza viruses likely to circulate in the United States in the upcoming winter.

Annual influenza vaccination is recommended by the Advisory Committee on Immunization Practices because immunity declines during the year after vaccination, and because circulating strains of influenza virus change from year to year.4

Clinical Studies

Efficacy Against Culture-Confirmed Influenza

The efficacy experience with FLUCELVAX is relevant to FLUCELVAX QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions.

A multinational (US, Finland, and Poland), randomized, observer-blind, placebo-controlled trial was performed to assess clinical efficacy and safety of FLUCELVAX during the 2007- 2008 influenza season in adults aged 18 through 49 years. A total of 11,404 subjects were enrolled to receive FLUCELVAX (N=3828), AGRIFLU (N=3676) or placebo (N=3900) in a 1:1:1 ratio. Among the overall study population enrolled, the mean age was 33 years, 55% were female, 84% were Caucasian, 7% were Black, 7% were Hispanic, and 2% were of other ethnic origin.

FLUCELVAX efficacy was assessed by the prevention of culture-confirmed symptomatic influenza illness caused by viruses antigenically matched to those in the vaccine and prevention of influenza illness caused by all influenza viruses compared to placebo.

Influenza cases were identified by active and passive surveillance of influenza-like illness (ILI). ILI was defined as a fever (oral temperature ≥100.0°F / 38°C) and cough or sore throat. Nose and throat swab samples were collected for analysis within 120 hours of onset of an influenza-like illness in the period from 21 days to 6 months after vaccination. Overall vaccine efficacy against all influenza viral subtypes and vaccine efficacy against individual influenza viral subtypes were calculated (Tables 5 and 6, respectively).

Table 5: Vaccine Efficacy against Culture-Confirmed Influenza

  Number of subjects per protocol Number of subjects with influenza Attack Rate
(%)
Vaccine Efficacy (VE)1,2
      % Lower Limit of One- Sided 97.5% CI of VE2,3
Antigenically Matched Strains
FLUCELVAX 3776 7 0.19 83.8 61.0
Placebo 3843 44 1.14 - -
All Culture-Confirmed Influenza
FLUCELVAX 3776 42 1.11 69.5 55.0
Placebo 3843 140 3.64 - -
1 Efficacy against influenza was evaluated over a 9 month period in 2007/2008
2 Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy (VE) of FLUCELVAX relative to placebo based on the Sidak-corrected score confidence intervals for the relative risk. Vaccine Efficacy = (1 - Relative Risk) x 100 %
3 VE success criterion: the lower limit of the one-sided 97.5% CI for the estimate of the VE relative to placebo is >40%
Study: NCT00630331

Table 6: Efficacy of FLUCELVAX against Culture-Confirmed Influenza by Influenza Viral Subtype

  FLUCELVAX
(N=3776)
Placebo
(N=3843)
Vaccine Efficacy
(VE)2
Attack Rate
(%)
Number of Subjects with Influenza Attack Rate
(%)
Number of Subjects with Influenza % Lower Limit of One- Sided 97.5% CI of VE1,2
Antigenically Matched Strains
A/H3N23 0. 05 2 0 0 - -
A/H1N1 0.13 5 1.12 43 88.2 67.4
B3 0 0 0.03 1 - -
All Culture-Confirmed Influenza
A/H3N2 0.16 6 0.65 25 75.6 35.1
A/H1N1 0.16 6 1.48 57 89.3 73.0
B 0.79 30 1.59 61 49.9 18.2
1 No VE success criterion was prespecified in the protocol for each individual influenza virus subtype.
2 Simultaneous one-sided 97.5% confidence intervals for the vaccine efficacy (VE) of FLUCELVAX relative to placebo based on the Sidak-corrected score confidence intervals for the relative risk. Vaccine Efficacy = (1 - Relative Risk) x 100 %;
3 There were too few cases of influenza due to vaccine-matched influenza A/H3N2 or B to adequately assess vaccine efficacy.
Study: NCT00630331

There are no data demonstrating prevention of influenza disease after vaccination with FLUCELVAX in the pediatric age group.

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, subjects 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 subjects who received FLUCELVAX QUADRIVALENT was 57.5 years; 55.1% of subjects were female and 76.1% of subjects 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 subjects who achieved seroconversions, defined as a pre-vaccination HI titer of <1:10 with a postvaccination 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 the QIVc, as assessed by ratios of GMTs and the differences in the percentages of subjects 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 Set [Study 1]

    FLUCELVAX QUADRIVALENT
N = 1250
TIV1c/TIV2c1
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 Rate2 (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)
372.3
(349.2-396.9)
1.0
(0.9-1.1)
-
Seroconversion Rate2 (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 Rate2 (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 Rate2 (95% CI) 39.8%
(37.0-42.5)
35.4%
(31.7-39.2)
- -4.4%
(-8.9-0.2)
Abbreviations: HI = hemagglutination inhibition. PPS = per protocol set. GMT = geometric mean titer. CI = confidence interval.
1 Per protocol set: All subjects 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 subjects 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

Immunogenicity In Children And Adolescents 4 Through 17 Years Of Age

Immunogenicity of FLUCELVAX QUADRIVALENT was evaluated in children 4 through 17 years of age in a randomized, double-blind, controlled study conducted in the US (Study 2). (See section 6.1) In this study, 1159 subjects received FLUCELVAX QUADRIVALENT.

In the per protocol set, the mean age of subjects who received FLUCELVAX QUADRIVALENT was 9.8 years; 47% of subjects were female and 54% of subjects were Caucasian, 22% were black and 19% were Hispanics. The immune response to each of the vaccine antigens was assessed, 21 days after vaccination.

The immunogenicity endpoints were the percentage of subjects who achieved seroconversion, defined as a pre-vaccination hemagglutination inhibition (HI) titer of <1:10 with a post- vaccination HI titer ≥1:40 or at least a 4-fold increase in serum HI titer; and percentage of subjects with a post-vaccination HI titer ≥1:40.

In subjects receiving FLUCELVAX QUADRIVALENT, for all four influenza strains, the 95% LBCI seroconversion rates were ≥40% and the percentage of subjects who achieved HI titer ≥1:40 post vaccination were ≥70% (95% LBCI). (See Table 8)

Table 8: The Percentage of Children and Adolescents 4 through 17 years of Age with Seroconversion1 and HI Titers ≥ 1:40 post vaccination with FLUCELVAX QUADRIVALENT– Per-Protocol Analysis Set2 [Study 2]

    FLUCELVAX QUADRIVALENT
A/H1N1   N = 1014
Seroconversion Rate1
(95% CI)
72% (69-75)
HI titer≥1:40 99% (98-100)
A/H3N2B1   N = 1013
Seroconversion Rate1
(95% CI)
47% (44-50)
HI titer≥1:40 100% (99-100)
    N = 1013
Seroconversion Rate1
(95% CI)
66% (63-69)
HI titer≥1:40 92% (91-94)
B2   N = 1009
Seroconversion Rate1
(95% CI)
73% (70-76)
HI titer≥1:40 91% (89-93)
Abbreviations: HI = hemagglutinin inhibition. CI = confidence interval.
Analyses are performed on data for day 22 for previously vaccinated subjects and day 50 for not previously vaccinated subjects.
1 Seroconversion rate = percentage of subjects 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 titer. Immunogenicity success criteria were met if the lower limit of the 95% confidence interval (CI) of the percentage of subjects with HI titer ≥1:40 is ≥70%; and the lower limit of the 95% CI of the percentage of subjects with seroconversion is ≥40%.
2 Per protocol set: All subjects 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.
Study 2: NCT 01992107

REFERENCES

2. Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res 2004; 103:133-138.

3. Hobson D, Curry RL, Beare A, etal. The role of serum hemagglutinin-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses. J Hyg Camb 1972; 767-777.

4. Centers for Disease Control and Prevention. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011; 60(33): 1128-1132.

Patient information

Inform vaccine recipients of the potential benefits and risks of immunization with FLUCELVAX QUADRIVALENT.

Educate vaccine recipients regarding the potential side effects; clinicians should emphasize that (1) FLUCELVAX QUADRIVALENT contains non-infectious particles and cannot cause influenza and (2) FLUCELVAX QUADRIVALENT is intended to provide protection against illness due to influenza viruses only, and cannot provide protection against other respiratory illnesses.

Instruct vaccine recipients to report adverse reactions to their healthcare provider.

Encourage women who receive FLUCELVAX QUADRIVALENT while pregnant to enroll in the pregnancy registry. Pregnant women can enroll in the pregnancy registry by calling 1-855-358-8966 or sending an email to Seqirus at [email protected]

Provide vaccine recipients with the Vaccine Information Statements which are required by the National Childhood Vaccine Injury Act of 1986. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/ vaccines).

Inform vaccine recipients that annual vaccination is recommended.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

Side effects

Clinical Trials Experience

The most common (≥10%) local and systemic reactions in adults 18 through 64 years of age were injection site pain (45.4%), headache (18.7%), fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).

The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%), and injection site erythema (11.9%)

The most common (≥10%) local and systemic reactions in children 4 through 5 years of age after first dose of vaccine were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%) and change in eating habits (10%).

The most common (≥10%) local and systemic reactions in children 6 through 8 years of age after first dose of vaccine were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%) and myalgia (12%).

The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%) and myalgia (16%), and injection site induration (15%).

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in clinical studies of another vaccine, and may not reflect rates observed in clinical practice.

Adults 18 Years Of Age And Older

The safety of FLUCELVAX QUADRIVALENT in adults was evaluated in a randomized, doubleblind, controlled study conducted in the US (Study 1). The safety population included a total of 2680 adults 18 years of age and older; 1340 adults 18 through 64 years of age and 1340 adults 65 years of age and older.

In this study, subjects received FLUCELVAX QUADRIVALENT or one of the two formulations of comparator trivalent influenza vaccine (TIV1c and TIV2c) (FLUCELVAX QUADRIVALENT (n=1335), TIV1c, n=676 or TIV2c, n= 669). The mean age of subjects who received FLUCELVAX QUADRIVALENT was 57.4 years of age; 54.8% of subjects were female and 75.6% were Caucasian, 13.4% were Black, 9.1% were Hispanics, 0.7% were American Indian and 0.3%, 0.1% and 0.7% were Asian, Native Hawaiian and others, respectively.

The safety data observed are summarized in Table 2.

In this study, solicited local injection site and systemic adverse reactions were collected from subjects who completed a symptom diary card for 7 days following vaccination. Solicited adverse reactions for FLUCELVAX QUADRIVALENT and comparator are summarized in Table 2.

Table 2: Incidence of Solicited Adverse Reactions in the Safety Population1 Reported Within 7 Days of Vaccination (Study 1)

  18 through 64 years of age ≥ 65 years of age
Percentages (%)2
FLUCELVAX
QUADRIVALENT
N=663
Trivalent Influenza
Vaccine
FLUCELVAX
QUADRIVALENT
N=656
Trivalent Influenza
Vaccine
TIV1c
N=330
TIV2c
N=327
TIV1c
N=340
TIV2c
N=336
Local Adverse Reactions
Injection site induration 11.6 (0) 9.7 (0.3) 10.4 (0) 8.7 (0) 6.8 (0) 7.7 (0)
Injection site erythema 13.4 (0) 13.3 (0) 10.1 (0) 11.9 (0) 10.6 (0) 10.4 (0)
Injection site ecchymosis 3.8 (0) 3.3 (0.3) 5.2 (0) 4.7 (0) 4.4 (0) 5.4 (0)
Injection site pain 45.4 (0.5) 37.0 (0.3) 40.7 (0) 21.6 (0) 18.8 (0) 18.5 (0)
Systemic Adverse Reactions
Chills 6.2 (0.2) 6.4 (0.6) 6.4 (0) 4.4 (0.3) 4.1 (0.3) 4.5 (0.6)
Nausea 9.7 (0.3) 7.3 (0.9) 8.9 (1.2) 3.8 (0.2) 4.1 (0) 4.2 (0.3)
Myalgia 15.4 (0.8) 14.5 (0.9) 15.0 (1.2) 8.2 (0.2) 9.4 (0.3) 8.3 (0.6)
Arthralgia 8.1 (0.5) 8.2 (0) 9.5 (0.9) 5.5 (0.5) 5.0 (0.3) 6.8 (0.9)
Headache 18.7 (0.9) 18.5 (0.9) 18.7 (0.6) 9.3 (0.3) 8.5 (0.6) 8.3 (0.6)
Fatigue 17.8 (0.6) 22.1 (0.3) 15.6 (1.5) 9.1 (0.8) 10.6 (0.3) 8.9 (0.6)
Vomiting 2.6 (0) 1.5 (0.3) 0.9 (0) 0.9 (0.2) 0.3 (0) 0.6 (0)
Diarrhea 7.4 (0.6) 7.6 (0) 7.6 (0.6) 4.3 (0.5) 5.0 (0.9) 5.1 (0.3)
Loss of
appetite
8.3 (0.3) 8.5 (0.3) 8.3 (0.9) 4.0 (0.2) 5.0 (0) 3.6 (0.3)
Fever:
≥38.0 °C (≥40.0°C)
0.8 (0) 0.6 (0) 0.3 (0) 0.3 (0) 0.9 (0) 0.6 (0)
1 Safety population: all subjects in the exposed population who provided post-vaccination safety data
2 Percentage of severe adverse reactions are presented in parenthesis
Study 1: NCT01992094

Unsolicited adverse events were collected for 21 days after vaccination. In adults 18 years of age and older, unsolicited adverse events were reported in 16.1% of subjects who received FLUCELVAX QUADRIVALENT, within 21 days after vaccination.

In adults 18 years of age and older, serious adverse events (SAEs) were collected throughout the study duration (until 6 months after vaccination) and were reported by 3.9%, of the subjects who received FLUCELVAX QUADRIVALENT. None of the SAEs were assessed as being related to study vaccine.

Children And Adolescents 4 Through 17 Years Of Age

The safety of FLUCELVAX QUADRIVALENT in children was evaluated in a randomized, double-blind, controlled study conducted in the US (Study 2). The safety population included a total of 2332 children 4 through 17 years of age; 1161 children 4 through 8 years of age and 1171 children 9 through 17 years of age.

In this study, subjects received FLUCELVAX QUADRIVALENT or one of the two formulations of comparator trivalent influenza vaccine (FLUCELVAX QUADRIVALENT n=1159, TIV1c, n=593 or TIV2c, n= 580). Children 9 through 17 years of age received a single dose of FLUCELVAX QUADRIVALENT or comparator vaccine. Children 4 through 8 years of age received one or two doses (separated by 4 weeks) of FLUCELVAX QUADRIVALENT or comparator vaccine based on determination of the subject’s prior influenza vaccination history. The mean age of subjects who received FLUCELVAX QUADRIVALENT was 9.6 years of age; 48% of subjects were female and 53% were Caucasian. The safety data observed are summarized in Table 3 and Table 4.

In this study, solicited local injection site and systemic adverse reactions were collected from subjects who completed a symptom diary card for 7 days following vaccination. Solicited adverse reactions for FLUCELVAX QUADRIVALENT and comparator are summarized in Table 3 and Table 4.

Table 3: Incidence of Solicited Adverse Reactions in the Safety Population1 (4 through 5 years of age) Reported Within 7 Days of the First dose of Vaccination (Study 2)

  Children 4 through 5 years
Percentages (%)2
FLUCELVAX
QUADRIVALENT
N=182
Trivalent Influenza Vaccine
TIV1c N=91 TIV2c N=93
Local Adverse Reactions
Injection site induration 13 (1) 20 (2) 13 (0)
Injection site erythema 18 (1) 23 (1) 17 (0)
Injection site ecchymosis 9 (0) 11 (0) 8 (0)
Injection site tenderness 46 (1) 45 (1) 43 (0)
Systemic Adverse Reactions
Change in eating habits 10 (1) 7 6
Sleepiness 19 (1) 12 (3) 10 (0)
Irritability 16 (2) 10 (2) 10 (1)
Chills 5 (1) 2 (0) 1 (0)
Vomiting 4 (0) 2 (0) 2 (0)
Diarrhea 4 (0) 2 (0) 2 (0)
Fever: ≥38.0 °C (≥40.0 °C) 4 (0) 4 (0) 3 (0)
1 Safety population: all subjects in the exposed population who provided post-vaccination safety data.
2 Percentage of subjects with severe adverse reactions are presented in parenthesis.
Study 2: NCT01992107

Table 4: Incidence of Solicited Adverse Reactions in the Safety Population1 (Children 6 through 17 years of age) Reported Within 7 Days of Vaccination (Study 2)

  Children 6 through 8 years
(after first dose)
Children 9 through 17 years
Percentages (%)2
FLUCELVAX
QUADRIVALENT
N=371- 372
Trivalent Influenza
vaccine
FLUCELVAX
QUADRIVALENT
N=579
Trivalent Influenza
Vaccine
TIV1c
N=185
TIV2c
N=186
TIV1c
N=294
TIV2c
N=281- 282
Local Adverse Reactions
Injection site induration 16 (0) 19 (1) 13 (0) 15 (0) 15 (0) 13 (<1)
Injection site erythema 22 (0) 23 (1) 20 (0) 19 (<1) 17 (0) 15 (<1)
Injection site ecchymosis 9 (0) 9 (0) 8 (0) 4 (0) 5 (0) 5 (0)
Injection site pain 54 (1) 57 (1) 58 (2) 58 (1) 51(<1) 50 (0)
Systemic Adverse Reactions
Chills 4 (1) 3 (0) 4 (0) 7 (0) 6 (1) 4 (1)
Nausea 8 (1) 5 (0) 5 (1) 9 (<1) 8 (1) 7 (1)
Myalgia 12 (1) 14 (0) 10 (0) 16 (<1) 17 (<1) 15 (<1)
Arthralgia 4 (0) 5 (0) 4 (0) 6 (0) 6 (0) 8 (<1)
Headache 14 (1) 13 (0) 12 (0) 22 (1) 23 (2) 18 (1)
Fatigue 13 (2) 14 (0) 18 (0) 18 (<1) 16 (1) 16 (<1)
Vomiting 3 (1) 3 (0) 3 (0) 2 (0) 1 (0) 2 (0)
Diarrhea 3 (<1) 6 (1) 5 (0) 4 (0) 4 (0) 3 (<1)
Loss of
appetite
9 (<1) 5 (0) 8 (1) 9 (0) 9 (<1) 9 (0)
Fever:
≥38.0 °C (≥40.0 °C)
4 (0) 3 (0) 2 (0) 1 (<1) 3 (0) 1 (0)
1 Safety population: all subjects in the exposed population who provided post-vaccination safety data.
2 Percentage of subjects with severe adverse reactions are presented in parenthesis.
Study 2: NCT 01992107

In children who received a second dose of FLUCELVAX QUADRIVALENT, TIV1c, or TIV2c, the incidence of adverse reactions following the second dose of vaccine were similar to those observed with the first dose.

Unsolicited adverse events were collected for 21 days after last vaccination. In children 4 through 17 years of age, unsolicited adverse events were reported in 24.3% of subjects who received FLUCELVAX QUADRIVALENT, within 3 weeks after last vaccination.

In children 4 through 17 years of age, serious adverse events (SAEs) were collected throughout the study duration (until 6 months after last vaccination) and were reported by 0.5% of the subjects who received FLUCELVAX QUADRIVALENT. None of the SAEs were assessed as being related to study vaccine.

Postmarketing Experience

The following additional adverse events have been identified during post-approval use of FLUCELVAX QUADRIVALENT. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Immune system disorders: Allergic or immediate hypersensitivity reactions, including anaphylactic shock.

Nervous systems disorders: Syncope, presyncope, paresthesia.

Skin and subcutaneous tissue disorders: Generalized skin reactions including pruritus, urticaria or non-specific rash.

General disorders and administration site conditions: Extensive swelling of injected limb.

Read the entire FDA prescribing information for Flucelvax Quadrivalent 2018-2019 Formula (Influenza Vaccine)

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