Vaccine Information: AFLURIA

AFLURIA- influenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (propiolactone inactivated) and influenza b virus b/maryland/15/2016 antigen (propiolactone inactivated) injection, suspension
AFLURIA- iinfluenza a virus a/singapore/gp1908/2015 ivr-180a (h1n1) antigen (propiolactone inactivated), influenza a virus a/singapore/infimh-16-0019/2016 ivr-186 (h3n2) antigen (propiolactone inactivated) and influenza b virus b/maryland/15/2016 antigen (propiolactone inactivated) injection, suspension
Seqirus Pty Ltd

1 INDICATIONS AND USAGE

AFLURIA® is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. AFLURIA is approved for use in persons 5 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular (IM) injection only, by needle and syringe (5 years of age and older) or by PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years of age). A single dose is 0.5 mL.

The dose and schedule for AFLURIA are presented in Table 1.

Table 1: AFLURIA Schedule
Age Schedule
*
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.
5 years through 8 years One dose or two doses at least 1 month apart *
9 years and older One dose

Shake thoroughly and inspect visually before use. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever suspension and container permit. If either of these conditions exists, the vaccine should not be administered.

May be administered by needle and syringe (5 years of age and older) or PharmaJet Stratis Needle-Free Injection System (18 through 64 years of age only).

When using the single-dose pre-filled syringe, shake the syringe thoroughly and administer the dose immediately.

When using the multi-dose vial, shake the vial thoroughly before withdrawing each dose, and administer the dose immediately.

  • Needle and Syringe: Draw up the exact dose using a separate sterile needle and syringe for each individual patient. It is recommended that small syringes (0.5 mL or 1 mL) be used to minimize any product loss.
  • PharmaJet Stratis Needle-Free Injection System: For instructions on withdrawal of a 0.5 mL dose and use of the PharmaJet Stratis Needle-Free Injection System, refer to the Instructions For Use for the PharmaJet Stratis Needle-Free Injection System.

The preferred site for intramuscular injection is the deltoid muscle of the upper arm.

Between uses, return the multi-dose vial to the recommended storage conditions between 2-8°C (36–46°F). Do not freeze. Discard if the vaccine has been frozen.

3 DOSAGE FORMS AND STRENGTHS

AFLURIA is a sterile suspension for intramuscular injection (see Description [11]).

AFLURIA is supplied in two presentations:

  • 0.5 mL pre-filled syringe (single dose).
  • 5 mL multi-dose vial (ten 0.5 mL doses).

4 CONTRAINDICATIONS

AFLURIA is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see Description [11]).

5 WARNINGS AND PRECAUTIONS

5.1 Fever and Febrile Seizures

Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 through 8 years of age.

5.2 Guillain-Barré Syndrome

If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks.

The 1976 swine influenza vaccine was associated with an increased frequency of GBS. Evidence for a causal relation of GBS with subsequent vaccines prepared from other influenza viruses is unclear. If influenza vaccine does pose a risk, it is probably slightly more than one additional case per 1 million persons vaccinated.

5.3 Preventing and Managing Allergic Reactions

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

5.4 Altered Immunocompetence

If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

5.5 Limitations of Vaccine Effectiveness

Vaccination with AFLURIA may not protect all individuals.

6 ADVERSE REACTIONS

In children 5 through 17 years of age, the most common injection-site reactions observed in clinical studies with AFLURIA administered by needle and syringe were pain (≥60%), redness (≥20%) and swelling (≥10%). The most common systemic adverse events were headache, myalgia (≥20%), irritability, malaise and fever (≥10%).

In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥60%), pain (≥40%), swelling (≥20%), redness and itching (≥10%). The most common systemic adverse events observed were muscle aches (≥30%), headache and malaise (≥20%).

In adults 18 through 64 years of age, using the PharmaJet Stratis Needle-Free Injection System, the most common injection-site adverse reactions observed in a clinical study with AFLURIA up to 7 days post-vaccination were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events within this period were myalgia, malaise (≥30%) and headache (≥20%).

In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies with AFLURIA administered by needle and syringe were tenderness (≥30%) and pain (≥10%). No systemic adverse reactions occurred in ≥10% of subjects in this age group.

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 the clinical studies of another vaccine and may not reflect the rates observed in clinical practice.

Children

In clinical studies, AFLURIA has been administered to, and safety information collected for, 3,009 children ages 6 months through 17 years. The exposure in children includes 1,601 aged 6 months to less than 5 years, 756 children ages 5 years to less than 9 years and 652 children ages 9 years through 17 years. Clinical safety data for AFLURIA in children are presented from three clinical studies (Studies 1, 2 and 3). Data from a comparator-controlled trial (Study 1) are presented, followed by pooled data from two open label studies (Studies 2 and 3). Subjects 6 months through 8 years of age received one or two vaccinations, administered by needle and syringe, as determined by previous vaccination history (for further details on clinical study design, dosing and demographics see Clinical Studies [14]).

Study 1 included 1,468 subjects for safety analysis, ages 6 months through 17 years, randomized to receive AFLURIA (735 subjects) or another U.S.-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur, Inc.) (733 subjects).

Study 2 included 1,976 subjects for safety analysis, ages 6 months through 17 years. All subjects received AFLURIA.

Study 3 included 298 subjects for safety analysis, ages 6 months through 8 years. All subjects received AFLURIA.

The safety assessment was similar for the three pediatric studies. Local (injection site) adverse reactions and systemic adverse events were solicited for 7 days post-vaccination (Tables 2 and 3). Unsolicited adverse events were collected for 30 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Among the pediatric studies, there were no vaccine-related deaths or vaccine-related serious adverse events reported in children 5 years of age and older.

In this section, safety data from the pediatric studies are limited to children 5 years of age and older. AFLURIA is not approved for use in children less than 5 years of age. See Warnings and Precautions [5.1] and Use in Specific Populations [8.4] for risks of AFLURIA in children less than 5 years of age.

In the comparator-controlled trial (Study 1), the rate of fever after the first dose of AFLURIA in subjects aged 5 through 8 years was 16% as compared to 8% in subjects who received the comparator. The rate of fever in subjects aged 9 through 17 years following a single dose of AFLURIA was 6% as compared to 4% in subjects who received the comparator. In all three pediatric studies, the rates of fever in subjects aged 5 through 8 years who received AFLURIA were lower after dose 2 than dose 1.

Data in Tables 2 and 3 are presented for children 5 years and older.

Table 2: Proportion of Subjects 5 through 17 Years of Age with Solicited Local Adverse Reactions or Systemic Adverse Events within 7 Days after Administration of First or Second Dose of AFLURIA, Irrespective of Causality (Study 1)
Percentage * of Subjects in each Age Group Reporting Event
Subjects 5 through 8 years Subjects 9 through 17 years
AFLURIAN=161 ComparatorN=165 AFLURIAN=254 ComparatorN=250
*
Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
N = number of subjects in the Safety Population for each treatment group.
After the First Dose
Local Adverse Reactions
Pain 63 60 66 60
Redness 23 27 17 17
Induration 17 17 15 16
Systemic Adverse Events
Myalgia 34 30 40 37
Malaise 24 13 22 20
Headache 21 19 27 26
Any Fever 16 8 6 4
Fever ≥102.2°F 5 1 3 1
Nausea/Vomiting 12 8 9 10
Diarrhea 7 7 8 10
AFLURIAN=39 ComparatorN=53
After the Second Dose
Local Adverse Reactions
Pain 36 38 - -
Redness 10 19 - -
Induration 8 17 - -
Systemic Adverse Events
Diarrhea 13 6 - -
Headache 13 13 - -
Myalgia 13 17 - -
Malaise 5 8 - -
Nausea/Vomiting 3 8 - -
Any Fever Fever ≥102.2°F 00 20
Table 3: Proportion of Subjects 5 through 17 Years of Age with Solicited Local Adverse Reactions or Systemic Adverse Events Within 7 Days after Administration of AFLURIA, Irrespective of Causality (Studies 2 and 3)
Percentage * of Subjects in each Age Group Reporting Event
Studies 2 and 3Subjects 5 through 8 years Study 2Subjects 9 through 17 years
Dose 1N=82-595 Dose 2N=82-426 Dose 1N=397
*
Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
N = number of subjects in the Safety Population for each treatment group. Denominators for Dose 1 were: N=82 for Vomiting/Diarrhea, Irritability, Loss of appetite, N=513 for Malaise, Diarrhea, Nausea/Vomiting and N=593-595 for all other parameters. Denominators for Dose 2 were: N=82 for Vomiting/Diarrhea, Irritability, Loss of appetite, N=344 for Malaise, Diarrhea and Nausea/Vomiting and N=421-426 for all other parameters.
These preferred terms were used to describe Solicited Adverse Events in Study 3.
§
These preferred terms were used to describe Solicited Adverse Events in Study 2.
Local Adverse Reactions
Pain 61 56 68
Erythema 24 23 17
Swelling 17 17 13
Systemic Adverse Events
Irritability 18 16 -
Headache 16 10 27
Malaise or feeling generally unwell § 16 8 17
Any Fever 13 6 5
Fever ≥ 102.2°F 3 2 1
General Muscle Ache (Myalgia) 12 8 20
Nausea/Vomiting § 7 3 5
Vomiting/Diarrhea 5 6 -
Loss of appetite 5 4 -
Diarrhea § 4 2 5

In Study 1, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 5 years through 8 years following the first or second dose included cough (15%) and pyrexia (9%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years through 17 years following the first dose included cough (7%), oropharyngeal pain (7%), headache (7%) and nasal congestion (6%).

In Studies 2 and 3, unsolicited adverse events that occurred in ≥ 5% of subjects ages 5 years through 8 years after the first or second dose included the following: upper respiratory tract infection (13%), cough (10%), rhinorrhea (7%), headache (5%), nasopharyngitis (5%) and pyrexia (5%). Unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA in ages 9 years through 17 years following the first dose included upper respiratory tract infection (9%) and headache (8%).

Adults

In clinical studies comparing AFLURIA to placebo or a comparator trivalent inactivated influenza vaccine, a single dose of AFLURIA was administered to, and safety information collected for, 11,104 subjects ages 18 through 64 years and 836 subjects ages 65 years and older. Clinical safety data for AFLURIA in adults are presented from three clinical studies (Studies 4 through 6) conducted in the US and one clinical study (Study 7) conducted in the UK

Study 4 included 1,357 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA (1,089 subjects) or placebo (268 subjects) (see Clinical Studies [14]).

Study 5 included 15,020 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA (10,015 subjects) or placebo (5,005 subjects) (see Clinical Studies [14]).

Study 6 included 1,266 subjects for safety analysis, ages 65 years and older, randomized to receive AFLURIA (630 subjects) or another U.S.-licensed trivalent inactivated influenza vaccine (manufactured by Sanofi Pasteur Inc.) as an active comparator (636 subjects) (see Clinical Studies [14]). Study 7 included 275 subjects for safety analysis, ages 65 years and older, randomized to receive AFLURIA (206 subjects) or a UK-licensed trivalent inactivated influenza vaccine (manufactured by GSK) as an active comparator (69 subjects).

The safety assessment was identical for the four adult studies. Local (injection-site) adverse reactions and systemic adverse events were solicited for 5 days post-vaccination (Table 4, studies 4 through 6). Unsolicited adverse events were collected for 21 days post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Among adult studies, there were no vaccine-related deaths or vaccine-related serious adverse events reported.

Table 4: Proportion of Subjects 18 Years of Age and Older with Solicited Local Adverse Reactions or Systemic Adverse Events within 5 Days after Administration of AFLURIA or Placebo, Irrespective of Causality (Studies 4, 5 and 6)
Percentage * of Subjects in each Age Group Reporting Event
Study 4Subjects 18 through 64 years Study 5Subjects 18 through 64 years Study 6Subjects ≥ 65 years
AFLURIAN=1087-1088 PlaceboN=266 AFLURIAN=10,015 PlaceboN=5005 AFLURIAN=630 ComparatorN=636
*
Proportion of subjects reporting each solicited local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
N = number of subjects in the Safety Population for each treatment group.
Local Adverse Reactions
Tenderness (Pain on touching) 60 18 69 17 36 31
Pain (without touching) 40 9 48 11 15 14
Redness 16 8 4 <1 3 1
Swelling 9 1 4 <1 7 8
Bruising 5 1 1 1 <1 1
Systemic Adverse Events
Headache 26 26 25 23 9 11
Malaise 19 19 29 26 7 6
Muscle aches 13 9 21 12 9 8
Nausea 6 9 7 6 2 1
Chills/Shivering 3 2 5 4 2 2
Fever 1 1 3 2 <1 1

In Study 4, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA or placebo (8% versus 6%, respectively).

In Study 5, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA or placebo included headache (AFLURIA 12%, placebo 11%) and oropharyngeal pain (AFLURIA 5%, placebo 5%).

In Study 6, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA (5%).

Studies 1 to 7 were all conducted when AFLURIA was administered by needle and syringe.

Additionally, safety information has been collected in a clinical study of AFLURIA administered using the PharmaJet Stratis Needle-Free Injection System (Study 8). Study 8 included 1,247 subjects for safety analysis, ages 18 through 64 years, randomized to receive AFLURIA by either the PharmaJet Stratis Needle-Free Injection System (624 subjects) or needle and syringe (623 subjects). No deaths or vaccine-related serious adverse events were reported in Study 8. Local (injection-site) adverse reactions and systemic adverse events were solicited for 7 days post-vaccination (Table 5).

Table 5: Proportion of Subjects 18 through 64 Years of Age with Solicited Local Adverse Reactions or Systemic Adverse Events within 7 Days after Administration of AFLURIA by PharmaJet Stratis Needle-Free Injection System or Needle and Syringe Irrespective of Causality (Study 8).
Percentage * of Subjects Reporting Event
Study 8Subjects 18 through 64 years
AFLURIA
PharmaJet Stratis Needle-Free Injection SystemN=540-616 Needle and SyringeN=599-606
*
Proportion of subjects reporting each local adverse reaction or systemic adverse event by treatment group based on the number of subjects contributing at least one data value for an individual sign/symptom (individual event denominators).
N = number of subjects in the Safety Population for each treatment group. Denominators for the PharmaJet Stratis Needle-Free Injection System group were: N=540 for itching and N=605-616 for all other parameters. Denominators for the needle and syringe group were: N=527 for itching and N=599-606 for all other parameters.
A total of 155 subjects (approximately randomly distributed between PharmaJet Stratis Needle-Free Injection System and needle and syringe groups) received Diary Cards without itching listed as a solicited symptom.
Local Adverse Reactions
Tenderness 89 78
Swelling 65 20
Pain 64 49
Redness 60 19
Itching 28 10
Bruising 18 5
Systemic Adverse Events
Myalgia 36 36
Malaise 31 28
Headache 25 22
Chills 7 7
Nausea 7 7
Vomiting 1 2
Fever 0 0

In Study 8, no unsolicited adverse events occurred in ≥ 5% of subjects who received AFLURIA administered via PharmaJet Stratis Needle-Free Injection System up to 28 days post-vaccination.

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