Vaccine Information: FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE)

FLUCELVAX QUADRIVALENT (PRE-FILLED SYRINGE) — influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/darwin/7/2019 antigen (mdck cell derived, propiolactone inactivated) and influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) — influenza a virus a/washington/19/2020 (h1n1) antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/tasmania/503/2020 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/darwin/7/2019 antigen (mdck cell derived, propiolactone inactivated) and influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Seqirus Inc.

1 INDICATIONS AND USAGE

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 2 years of age and older. [see Clinical Studies (14)]

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Dosage and Schedule

Administer FLUCELVAX QUADRIVALENT as a single 0.5 mL intramuscular injection.

Table 1: Dosage and Schedule

1 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines.

Age Dose Schedule
2 through 8 years of age One or two doses1 , 0.5 mL each If 2 doses, administer at least 4 weeks apart
9 years of age and older One dose, 0.5mL Not Applicable

2.2 Administration

Shake the syringe vigorously before administering and shake the multi-dose vial preparation each time before withdrawing a dose of vaccine. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. [see Description (11)] If either condition exists, do not administer the vaccine. Between uses, return the multi-dose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

Attach a sterile needle to the pre-filled syringe.

For the multi-dose vial, a separate sterile syringe and needle must be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped. It is recommended that small syringes (0.5 mL or 1 mL) should be used to minimize any product loss.

Administer intramuscularly only, preferably in the region of the deltoid muscle of the upper arm. Younger children with insufficient deltoid mass should be vaccinated in the anterolateral aspect of the thigh. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk. Do not administer this product intravenously, intradermally or subcutaneously.

3 DOSAGE FORMS AND STRENGTHS

FLUCELVAX QUADRIVALENT is a suspension for injection supplied in two presentations:

  • a 0.5 mL single-dose pre-filled Luer Lock syringe
  • a 5 mL multi-dose vial containing 10 doses (each dose is 0.5 mL)

4 CONTRAINDICATIONS

Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome

The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated.1 If GBS has occurred after receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.

5.2 Preventing and Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

5.3 Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.

5.4 Altered Immunocompetence

After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.

5.5 Limitations of Vaccine Effectiveness

Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.

6 ADVERSE REACTIONS

In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported (≥10%) injection-site adverse reactions were pain (≥ 40%), erythema and induration (≥10%). The most common systemic adverse events were headache, fatigue and myalgia (≥10%).

In adults ≥ 65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (≥ 20%) and erythema (≥ 10%).

In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse events were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).

In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse events were headache (18.1%) and fatigue (17.0%). (6)

6.1 Clinical Trials Experience

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, double-blind, 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, adults 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 adults who received FLUCELVAX QUADRIVALENT was 57.4 years of age; 54.8% of adults 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 adults 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 Adult Safety Population1 Reported Within 7 Days of Vaccination (Study 1)
Percentage (%) 2 of participants in each Age Cohort Reporting an Event
Participants 18 through 64 years Participants ≥ 65 years
FLUCELVAX Quadrivalent N=663 TIV1c N=330 TIV2c N=327 FLUCELVAX QuadrivalentN=656 TIV1c N=340 TIV2c N=336

Abbreviations: Gr 3, Grade 3.

N = number of participants in the Safety Population for each study vaccine group.

1 Safety population: all participants in the exposed population who provided post-vaccination safety data

2 Proportion of participants reporting each solicited local adverse reaction or systemic adverse event by study vaccine group based on the number of participants contributing any follow up safety information for at least one data value of an individual sign/symptom

3 Local Adverse reactions: Grade 3 pain is that which prevents daily activity; Erythema, induration and ecchymosis: any = ≥ 1mm diameter, Grade 3 = > 100 mm diameter.

4 Systemic adverse events: Fever: any = ≥ 100.4°F (Oral), Grade 3 = ≥ 102.2°F (Oral); Grade 3 vomiting: requires outpatient hydration; Grade 3 diarrhea: 6 or more stools or requires outpatient IV hydration; Grade 3 for all other adverse events is that which prevents daily activity.

Study 1: NCT01992094

Any Gr 3 Any Gr 3 Any Gr 3 Any Gr 3 Any Gr 3 Any Gr 3
Local Adverse Reactions 3
Pain 45.4 0.5 37.0 0.3 40.7 0 21.6 0 18.8 0 18.5 0
Erythema 13.4 0 13.3 0 10.1 0 11.9 0 10.6 0 10.4 0
Induration 11.6 0 9.7 0.3 10.4 0 8.7 0 6.8 0 7.7 0
Ecchymosis 3.8 0 3.3 0.3 5.2 0 4.7 0 4.4 0 5.4 0
Systemic Adverse Reactions 4
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
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
Nausea 9.7 0.3 7.3 0.9 8.9 1.2 3.8 0.2 4.1 0 4.2 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
Arthralgia 8.1 0.5 8.2 0 9.5 0.9 5.5 0.5 5.0 0.3 6.8 0.9
Diarrhea 7.4 0.6 7.6 0 7.6 0.6 4.3 0.5 5.0 0.9 5.1 0.3
Chills 6.2 0.2 6.4 0.6 6.4 0 4.4 0.3 4.1 0.3 4.5 0.6
Vomiting 2.6 0 1.5 0.3 0.9 0 0.9 0.2 0.3 0 0.6 0
Fever 0.8 0 0.6 0 0.3 0 0.3 0 0.9 0 0.6 0

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 adults 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 adults who received FLUCELVAX QUADRIVALENT. None of the SAEs were assessed as being related to study vaccine.

Children and Adolescents 2 through 17 years of age:

The safety of FLUCELVAX QUADRIVALENT was evaluated in children and adolescents in Study 2.

Study 2 was a multi-season, multi-national (Australia, Estonia, Finland, Lithuania, Philippines, Poland, Spain, Thailand), randomized, observer-blind study in children and adolescents 2 through 17 years of age. The solicited safety population included a total of 4509 children and adolescents 2 through 17 years of age who received FLUCELVAX QIV (N=2255) or a non-influenza (meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate) comparator vaccine (N=2254).

Children 2 through 8 years of age received 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.

In this study, solicited local injection site and systemic adverse reactions were collected from children and adolescents who completed a symptom diary card for 7 days following vaccination.

In children 2 through 8 and children and adolescents 9 through 17 years of age, the incidence of local and systemic solicited adverse reactions reported by children and adolescents who received FLUCELVAX QUADRIVALENT and comparator are summarized in Table 3.

Table 3: Incidence of Solicited Adverse Reactions in the Safety Population1 (2 through 8 and 9 through 17 years of age) Reported Within 7 Days of Any Dose of Vaccination (Study 2)
Percentage (%) 2 of participants in each Age Cohort Reporting an Event
Participants 2 through 8 years Participants 9 through 17 years
FLUCELVAX Quadrivalent N=559-1143 Comparator 3 N=562-1142 FLUCELVAX QuadrivalentN=1096-1109 Comparator 3 N=1100-1108

Abbreviations: Gr 3, Grade 3.

N = number of participants in the Safety Population for each study vaccine group.

1 Solicited Safety Population: participants who were vaccinated and provided any solicited local or systemic adverse event safety data, from 6 hours through 7 days after vaccination.

2 Proportion of participants reporting each solicited local adverse reaction or systemic adverse event by study vaccine group based on the number of participants contributing any follow up safety information for at least one data value of an individual sign/symptom

3 Non-influenza vaccine 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.4 Local Adverse reactions: Grade 3 pain is that which prevents daily activity; Erythema, induration and ecchymosis: any = ≥ 1mm diameter, Grade 3 = > 50 mm diameter for 2 through 5 years and > 100 mm diameter for 6 through 17 years.

5 Tenderness, change in eating habits, sleepiness, and irritability were collected for participants 2 through 6 years of age only.

6 Systemic adverse events: Fever: any = ≥ 100.4°F (Oral), Grade 3 = ≥ 102.2°F (Oral); Grade 3 change of eating habits: Missed more than 2 feeds/meals; Grade 3 sleepiness: Sleeps most of the time and is hard to arouse him/her; Grade 3 vomiting: 6 or more times in 24 hours or requires intravenous hydration; Grade 3 diarrhea: 6 or more loose stools in 24 hours or requires intravenous hydration; Grade 3 irritability: unable to console. Grade 3 for all other adverse events is that which prevents daily activity.

The rates of antipyretic or analgesic use reported on the diary card for prophylaxis or treatment of high temperature or pain were as follows: 2 through 8 years of age FLUCELVAX QUADRIVALENT 11.0%, Comparator 7.7%; 9 through 18 years of age FLUCELVAX QUADRIVALENT 6.7%, Comparator 7.1%.

Study 2: NCT03165617

Any Gr 3 Any Gr 3 Any Gr 3 Any Gr 3
Local Adverse Reactions 4
Tenderness5 28.7 1.0 25.4 1.4
Pain 27.9 1.2 20.3 1.6 21.7 0.5 18.3 1.0
Erythema 21.3 0.4 23.7 1.1 17.2 0 18.7 0.5
Induration 14.9 0.2 15.2 0.4 10.5 0.1 11.0 0.2
Ecchymosis 10.0 0 7.5 0.1 5.0 0 5.2 0
Systemic Adverse Reactions 6
Sleepiness5 14.9 0.9 17.6 1.8
Headache 13.8 0.4 11.8 0.5 18.1 1.4 17.4 0.6
Fatigue 13.8 0.9 12.7 0.7 17.0 1.1 18.2 1.2
Irritability5 13.8 0.2 10.8 0.5
Loss of Appetite 10.6 0.5 8.0 0.5 8.5 0.5 7.5 0.5
Change of eating habits5 9.9 1.0 10.1 0.7
Fever 7.6 0.5 6.1 0.2 2.8 0.1 3.0 0.3
Diarrhea 6.5 0.4 6.8 0.6 7.4 0.5 8.1 0.3
Arthralgia 5.2 0.4 6.2 0.3 7.1 0.4 8.4 0.5
Nausea 5.2 0 4.5 0.7 6.0 0.2 6.1 0.6
Vomiting 4.9 0.6 4.1 0.6 3.0 0.3 3.0 0.4
Shivering/Chills 4.7 0.7 3.9 0.4 7.6 0.4 7.6 0.3
Myalgia 2.9 0.2 4.0 0.3 6.1 0.5 5.5 0.5

In children who received a second dose (N=762) of FLUCELVAX QUADRIVALENT, the rates of solicited local and systemic adverse reactions were generally lower after the second dose compared to the first dose.

Serious adverse events (SAEs) were collected throughout the study duration (until 6 months after last vaccination) and were reported by 1.1% of the children and adolescents who received FLUCELVAX QUADRIVALENT. None of the SAEs were assessed as being related to study vaccine.

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