Vaccine Information: FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE)

FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) — influenza a virus a/idaho/07/2018 (h1n1) antigen (mdck cell derived, propiolactone inactivated, influenza a virus a/indiana/08/2018 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) and influenza b virus b/iowa/06/2017 antigen (mdck cell derived, propiolactone inactivated) injection, suspension
FLUCELVAX QUADRIVALENT (MULTI-DOSE VIAL) — influenza a virus a/idaho/07/2018 (h1n1) antigen (mdck cell derived, propiolactone inactivated, influenza a virus a/indiana/08/2018 (h3n2) antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/singapore/inftt-16-0610/2016 antigen (mdck cell derived, propiolactone inactivated) and influenza b virus b/iowa/06/2017 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 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 (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 preferably in the region of the deltoid muscle of the upper arm. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk.

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
4 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. 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. 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

6.1 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, 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, 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 QUADRIVALENTN=663 Trivalent Influenza Vaccine FLUCELVAX QUADRIVALENTN=656 Trivalent Influenza Vaccine
TIV1cN=330 TIV2cN=327 TIV1cN=340 TIV2cN=336

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

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)

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 QUADRIVALENTN=182 Trivalent Influenza Vaccine
TIV1cN=91 TIV2cN=93

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

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)
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 QUADRIVALENTN=371-372 Trivalent Influenza vaccine FLUCELVAX QUADRIVALENTN=579 Trivalent Influenza Vaccine
TIV1cN=185 TIV2cN=186 TIV1cN=294 TIV2cN=281-282

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

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)

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.

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