Drug: Afluria

AFLURIA, Influenza Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution. AFLURIA is standardized according to USPHS requirements for the 2014-2015 influenza season and is formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2014-2015 Northern Hemisphere influenza season: A/California/7/2009 (H1N1), NYMC X- 181, A/Texas/50/2012 (H3N2), NYMC X-223 and B/Massachusetts/2/2012, NYMC BX-51B. Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentations; therefore these products contain no preservative. The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury. A single 0.5 mL dose of AFLURIA contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate ( ≤ 10 ppm), ovalbumin ( ≤ 1 mcg), neomycin sulfate ( ≤ 3 nanograms [ng]), polymyxin B ( ≤ 0.5 ng), and beta-propiolactone ( ≤ 2 ng). The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial were not made with natural rubber latex.

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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. 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. Clinical safety data for AFLURIA in children are presented from three clinical studies (Studies 1, 2 and 3). Data from a comparatorcontrolled 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). 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 and Use In Specific Populations 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)
  Percentagea of Subjects in each Age Group Reporting Event Subjects 5 through 8 years Subjects 9 through 17 years AFLURIA N=161 b Comparator N=165 b AFLURIA N=254 b Comparator N=250 b 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   AFLURIA Comparator   N=39 b N=53 b 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 0 2 - -   Fever ≥ 102.2°F 0 0 - - a 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).
b N = number of subjects in the Safety Population for each treatment group. 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)
  Percentagea of Subjects in each Age Group Reporting Event Studies 2 and 3 Subjects 5 through 8 years Study 2 Subjects 9 through 17 years Dose 1
N=82-595 b Dose 2
N=82-426 b Dose 1
N=397 b Local Adverse Reactions Pain 61 56 68 Erythema 24 23 17 Swelling 17 17 13 Systemic Adverse Events Irritabilityd 18 16 - Headache 16 10 27 Malaise or feeling generally unwell c 16 8 17 Any Fever 13 6 5   Fever ≥ 102.2°F 3 2 1 General Muscle Ache(Myalgia) 12 8 20 Nausea/Vomiting c 7 3 5 Vomiting/Diarrhea d 5 6 - Loss of appetite d 5 4 - Diarrhea c 4 2 5 a 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).
b 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/V omiting and N=421 -426 for all other parameters.
c These preferred terms were used to describe Solicited Adverse Events in Study 2.
d These preferred terms were used to describe Solicited Adverse Events in Study 3. 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 another U.S.-licensed 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). In these studies, Afluria and comparator vaccine or placebo were administered by needle and syringe. 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). 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). 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). The safety assessment was identical for the three adult studies. Local (injection-site) adverse reactions and systemic adverse events were solicited for 5 days post-vaccination (Table 4). 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 4 through 6, 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 a of Subjects in each Age Group Reporting Event Study 4 Subjects 18 through 64 years Study 5 Subjects 18 through 64 years Study 6 Subjects ≥ 65 years AFLURIA
N=1087-1088 b Placebo
N=266 b AFLURIA
N=10,015 b Placebo
N=5005 b AFLURIA
N=630 b Comparator
N=636 b 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 a 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).
b N = number of subjects in the Safety Population for each treatment group. 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, headache was the only unsolicited adverse event that occurred in ≥ 5% of subjects who received AFLURIA or placebo (12% versus 11%, respectively). In Study 6, unsolicited adverse events that occurred in ≥ 5% of subjects who received AFLURIA included headache (8%), nasal congestion (7%), cough (5%), rhinorrhea (5%), and pharyngolaryngeal pain (5%). Studies 1 to 6 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 7). Study 7 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 7. 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 7).
  Percentage a of Subjects Reporting Event Study 7 Subjects 18 through 64 years AFLURIA PharmaJet Stratis Needle-Free Injection System
N=540-616 b Needle and Syringe
N=599-606 b Local Adverse Reactions Tenderness 89 78 Swelling 65 20 Pain 64 49 Redness 60 19 Itching c 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 a 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).
b 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.
c 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. In Study 7, 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. Postmarketing Experience Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. The adverse reactions described have been included in this section because they: 1) represent reactions that are known to occur following immunizations generally or influenza immunizations specifically; 2) are potentially serious; or 3) have been reported frequently. These adverse reactions reflect experience in both children and adults and include those identified during post-approval use of AFLURIA outside the US since 1985. Blood and Lymphatic System Disorders Transient thrombocytopenia Immune System Disorders Allergic reactions including anaphylactic shock and serum sickness Nervous System Disorders Neuralgia, paresthesia, convulsions (including febrile seizures), encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS Vascular Disorders Vasculitis with transient renal involvement Skin and Subcutaneous Tissue Disorders Pruritus, urticaria, and rash General Disorders and Administration Site Conditions Cellulitis and large injection site swelling Adverse Reactions Associated With Influenza Vaccination Anaphylaxis has been reported after administration of AFLURIA. Egg protein can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, asthma, and systemic anaphylaxis (see CONTRAINDICATIONS). Neurological disorders temporally associated with influenza vaccination, such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy, have been reported. Microscopic polyangiitis (vasculitis) has been reported temporally associated with influenza vaccination. Read the Afluria (influenza virus vaccine) Side Effects Center for a complete guide to possible side effectsLearn More »

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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 5 years through 8 years One dose or two doses at least 1 month apart a 9 years and older One dose a 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. 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.

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Concurrent Use With Other Vaccines There are no data to assess the concomitant administration of AFLURIA with other vaccines. If AFLURIA is given at the same time as another injectable vaccine(s), the vaccine(s) should be administered in separate syringes and a separate arm should be used. AFLURIA should not be mixed with any other vaccine in the same syringe or vial. Concurrent Use With Immunosuppressive Therapies The immunological response to AFLURIA may be diminished in individuals receiving corticosteroid or immunosuppressive therapies. Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

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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.

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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). Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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Dosage Forms And Strengths AFLURIA is a sterile suspension for intramuscular injection (see DESCRIPTION). AFLURIA is supplied in two presentations:
  • 0.5 mL pre-filled syringe (single dose).
  • 5 mL multi-dose vial (ten 0.5 mL doses).
Each product presentation includes a package insert and the following components Presentation Carton NDC Number Components Pre-Filled Syringe 33332-014-01
  • Ten 0.5 mL single-dose syringes without needles [NDC 33332-014-02]
Multi-Dose Vial 33332-114-10
  • One 5 mL vial, which contains ten 0.5 mL doses [NDC 33332-114-11]
Storage And Handling
  • Store refrigerated at 2-8°C (36-46°F).
  • Do not freeze. Discard if product has been frozen.
  • Protect from light.
  • Do not use AFLURIA beyond the expiration date printed on the label.
  • Once the stopper of the multi-dose vial has been pierced the vial must be discarded within 28 days.
Manufactured by: bioCSL Pty Ltd., Parkville, Victoria, 3052, Australia, US License No. 1764. Distributed by: bioCSL Inc. 1020 First Avenue, King of Prussia, PA 19406, USA. Revised: August 2014 Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

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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. Guillain-Barre Syndrome If Guillain-Barre 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. Preventing And Managing Allergic Reactions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. Altered Immunocompetence If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished. Limitations Of Vaccine Effectiveness Vaccination with AFLURIA may not protect all individuals. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility AFLURIA has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. A reproductive study of female rats vaccinated with AFLURIA revealed no impairment of fertility (see Pregnancy). Use In Specific Populations Pregnancy Pregnancy Category B A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to AFLURIA. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, AFLURIA should be given to a pregnant woman only if clearly needed. In the reproductive and developmental toxicity study, the effect of AFLURIA on embryo-fetal and pre-weaning development was evaluated in pregnant rats. Animals were administered AFLURIA by intramuscular injection twice prior to gestation, once during the period of organogenesis (gestation day 6), and once later in pregnancy (gestation day 20), 0.5 mL/rat/occasion (approximately a 265-fold excess relative to the projected human dose on a body weight basis). No adverse effects on mating, female fertility, pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis. Nursing Mothers AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman. Pediatric Use AFLURIA is not approved for use in children less than 5 years of age. In a clinical study in which children received AFLURIA or a US-licensed comparator vaccine (Study 1, see Clinical Trials Experience), the incidence of fever in children 6 months through 35 months of age following the first and second doses of AFLURIA were 37% and 15%, respectively, as compared to 14% following each dose in the comparator group. Among children 3 years through 4 years of age, the incidence of fever following the first and second doses of AFLURIA were 32% and 14%, respectively, as compared to 11% and 16% in the comparator. In an open-label study (Study 2), fever, irritability, loss of appetite, and vomiting/diarrhea occurred more frequently in children 6 months through 35 months of age as compared to older children. Across three pediatric studies of AFLURIA (Studies 1, 2, and 3), 1.2% of eligible children (n=1,764) were discontinued from the second vaccination because of severe fever ( ≥ 104°F) within 48 hours of the first vaccination. Across the three pediatric studies, two children, a 7-month old and a 3-year old, experienced vaccine-related febrile seizures (rate of 0.07% across studies), one of which was serious. Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with increased rates of fever and febrile seizures, predominantly in children below the age of 5 years as compared to previous years, in postmarketing reports confirmed by postmarketing studies (see WARNINGS AND PRECAUTIONS). The PharmaJet Stratis Needle-Free Injection System is not approved as a method of administering AFLURIA to children and adolescents less than 18 years of age due to lack of adequate data supporting safety and effectiveness in this population. Geriatric Use In clinical studies, AFLURIA has been administered to, and safety information collected for, 836 subjects ages 65 years and older (see Clinical Trials Experience). After administration of AFLURIA, hemagglutination-inhibiting antibody responses in persons 65 years of age and older were lower as compared to younger adult subjects (see Clinical Studies). The PharmaJet Stratis Needle-Free Injection System is not approved as a method of administering AFLURIA to adults 65 years of age and older due to lack of adequate data supporting safety and effectiveness in this population. Last reviewed on RxList: 9/8/2014
This monograph has been modified to include the generic and brand name in many instances.

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