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Afluria

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Afluria

Side Effects
Interactions

SIDE EFFECTS

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 effects

DRUG INTERACTIONS

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.

Side Effects
Interactions
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