May 24, 2016
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Influenza A H1N1 Monovalent Vaccine

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Influenza A H1N1 Monovalent Vaccine

Side Effects
Interactions

SIDE EFFECTS

CSL's Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (AFLURIA) are manufactured by the same process. The data in this section were obtained from clinical studies and postmarketing experience with AFLURIA.

Overall Adverse Reactions

Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AFLURIA.

In adults, the most common local (injection-site) adverse reactions observed in clinical studies with AFLURIA were tenderness, pain, redness and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches.

In children, the most common local (injection-site) adverse reactions observed in a clinical study with AFLURIA were pain, redness and swelling. The most common systemic adverse reactions observed were irritability, rhinitis, fever, cough, loss of appetite, vomiting/diarrhea, headache, muscle aches and sore throat.

Safety Experience From Clinical Studies

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.

Clinical data for AFLURIA have been obtained in four clinical studies, three in adult populations and one in a pediatric population (see Clinical Studies). Safety data are provided for two of the adult studies and the pediatric study.

A US study (Study 1) included 1,357 subjects for safety analysis, ages 18 to less than 65 years, randomized to receive AFLURIA (1,089 subjects) or placebo (268 subjects) (see Clinical Studies for study demographics). There were no deaths or serious adverse events reported in this study.

A UK study (Study 2) included 275 subjects, ages 65 years and older, randomized to receive preservative-free AFLURIA (206 subjects) or a European-licensed trivalent inactivated influenza vaccine as an active control (69 subjects) (see Clinical Studies). There were no deaths or serious adverse events reported in this study.

An open-label, uncontrolled study in children, conducted in Australia (Study 4), included 298 subjects, ages 6 months to less than 9 years. All subjects received preservative-free AFLURIA administered as two doses, one month apart (see Clinical Studies). Subjects were subdivided into two age groups: children ages 6 months to less than 3 years (151 subjects) received two 0.25 mL doses of AFLURIA and children ages 3 years to less than 9 years (147 subjects) received two 0.5 mL doses of AFLURIA. There were no deaths or vaccine-related serious adverse events reported in this study.

The safety assessment was identical for the two adult studies. Local (injection-site) and systemic adverse events were solicited by completion of a symptom diary card for 5 days post-vaccination (Table 1). Unsolicited adverse events were collected for 21 days post-vaccination (Table 2). These unsolicited adverse events were reported either spontaneously or when subjects were questioned about any changes in their health post-vaccination. All adverse events are presented regardless of any treatment causality assigned by study investigators.

In the pediatric study, solicited adverse events were recorded for up to 7 days (Table 3) and unsolicited adverse events were recorded for 30 days post-vaccination (Table 4). Data are presented following each dose for each age group. All adverse events are presented regardless of any treatment causality assigned by study investigators.

Table 1: Proportion of Subjects With Solicited Local or Systemic Adverse Events* Within 5 Days After Administration of AFLURIA or Placebo, Irrespective of Causality† (Studies 1 and 2, Adult Populations)

Solicited Adverse event Study 1
Subjects ≥ 18 to < 65 years
Study 2
Subjects ≥ 65 years
AFLURIA‡ 
n=1089
Placebo §
n=268
AFLURIA
n=206
Local
Tenderness|| 60% 18% 34%
Pain¶ 40% 9% 9%
Redness 16% 8% 23%
Swelling 9% 1% 11%
Bruising 5% 1% 4%
Systemic
Headache 26% 26% 15%
Malaise 20% 19% 10%
Muscle aches 13% 9% 14%
Nausea 6% 9% 3%
Chills/ Shivering 3% 2% 7%
Fever ≥ 37.7°C (99.9°F) 1% 1% 1%
Vomiting 1% 1% 0%
* In Study 1, 87% of solicited local and systemic adverse events were mild, 12% were moderate, and 1% were severe. In Study 2, 76.5% were mild, 20.5% were moderate, and 3% were severe. In both studies, most solicited local and systemic adverse events lasted no longer than 2 days.
† Values rounded to the nearest whole percent.
‡ Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA.
§ Thimerosal-containing placebo.
||Tenderness defined as pain on touching.
¶Pain defined as spontaneously painful without touch.

Table 2: Adverse Events* Reported Spontaneously by ≥ 1% of Subjects Within 21 Days After Administration of AFLURIA or Placebo, Irrespective of Causality† (Studies 1 and 2, Adult Populations)

Adverse Event Study 1
Subjects ≥ 18 to < 65 years
Study 2
Subjects ≥ 65 years
AFLURIA‡ 
n=1089
Placebo §
n=268
AFLURIA 
n=206
Headache 8% 6% 8%
Nasal Congestion 1% 1% 7%
Cough 1% 0.40% 5%
Rhinorrhea 1% 1% 5%
Pharyngolaryngeal Pain 3% 1% 5%
Reactogenicity Event 3% 3% 0%
Diarrhea 2% 3% 1%
Back Pain 2% 0.40% 2%
Upper Respiratory Tract Infection 2% 1% 0.50%
Viral Infection 0.40% 1% 0%
Lower Respiratory Tract Infection 0% 0% 1%
Myalgia 1% 1% 1%
Muscle Spasms 0.40% 1% 0%
* In Study 1, 63% of unsolicited adverse events were mild, 35% were moderate, and 2% were severe. In Study 2, 47% were mild, 51% were moderate, and 3% were severe. In both studies, most unsolicited adverse events lasted no longer than 5 days.
† Values rounded to the nearest whole percent.
‡ Includes subjects who received either the single-dose (preservative-free) or multi-dose formulation of AFLURIA.
§ Thimerosal-containing placebo.

Table 3: Proportion of Subjects With Solicited Local or Systemic Adverse Events* Within 7 Days After Administration of AFLURIA, Irrespective of Causality† (Study 4, Pediatric Population)

Solicited Adverse Event Subjects ≥ 6 months to < 3 years
(n = 151)‡
Subjects ≥ 3 years to < 9 years
(n = 147)§
Dose 1 Dose 2 Dose 1 Dose 2
Local
Pain 36% 37% 59% 62%
Erythema 36% 38% 37% 46%
Swelling 16% 21% 25% 27%
Systemic
Irritability 48% 41% 20% 17%
Rhinitis 37% 48% 21% 29%
Fever1 23% 23% 16% 8%
Cough 21% 32% 19% 19%
Loss of appetite 19% 24% 8% 5%
Vomiting/Diarrhea 15% 14% 8% 7%
Headache 2%' 3%** 14% 11%
Myalgia 1%# 3%** 14% 8%
Sore throat 2%' 5%** 8% 11%
Wheezing/ Shortness of breath 3% 9% 3% 2%
Ear ache 3%** 3%# 4% 1%
* In Study 4, 78% of all local and systemic solicited events experienced by children ages 6 months to less than 3 years were mild, 19% were moderate and 3% were severe; 76% of all events experienced by children ages 3 years to less than 9 years were mild, 20% moderate and 4% severe. Severe pain was reported by < 1% of children ages 6 months to less than 3 years and 3% in children ages 3 years to less than 9 years. Severe fever ( > 103.1°F axillary or > 104.0°F oral) was reported by < 1% of subjects in children ages 6 months to less than 3 years and 1% of subjects in children ages 3 years to less than 9 years.
† Values rounded to the nearest whole percent.
‡ Dosage in children 6 months to less than 3 years of age was 0.25 mL.
§ Dosage in children 3 years to less than 9 years of age was 0.5 mL.
|| Axillary Temperature ≥ 37.5°C (99.5°F) or Oral Temperature ≥ 38.0°C (100.4 °F).
¶Data obtained from a total of 148 subjects.
# Data obtained from a total of 149 subjects.
** Data obtained from a total of 150 subjects.

Table 4: Adverse Events* Reported Spontaneously by ≥ 5% of Subjects Within 30 Days After Administration of AFLURIA, Irrespective of Causality (Study 4, Pediatric Population)

Adverse Event Subjects ≥ 6 months to < 3 years
(n = 151)†
Subjects ≥ 3 to < 9 years
(n = 147)‡
Dose 1 Dose 2 Dose 1 Dose 2
Nasopharyngitis 5.30% 7.90% 5.40% 5.40%
Rhinitis 13.20% 9.90% 6.80% 10.90%
Upper Respiratory Tract Infection 9.90% 7.30% 6.10% 6.10%
Irritability 3.30% 5.30% 0.70% 0.70%
Headache 1.30% 0.70% 6.10% 4.10%
Cough 10.60% 13.20% 10.90% 13.60%
Rhinorrhea 7.30% 6.00% 6.80% 4.80%
Teething 14.60% 9.90% 0.00% 0.00%
Vomiting 5.30% 2.60% 2.00% 2.70%
Influenza-like Illness 13.90% 10.60% 6.80% 3.40%
Pyrexia 2.60% 9.30% 2.70% 4.10%
* In Study 4, for both doses and both groups combined, 47% of unsolicited adverse events were mild, 42% were moderate, and 12% were severe.
† Dosage in children 6 months to less than 3 years of age was 0.25 mL.
‡ Dosage in children 3 years to less than 9 years of age was 0.5 mL.

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, and convulsions; encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS

Vascular Disorders

Vasculitis with transient renal involvement

Skin And Subcutaneous Tissue Disorders

Pruritus, urticaria, and rash

Other Adverse Reactions Associated With Influenza Vaccination

Anaphylaxis has been reported after administration of AFLURIA. Although AFLURIA and Influenza A (H1N1) 2009 Monovalent Vaccine contain only a limited quantity of egg proteins, these proteins can induce immediate hypersensitivity reactions among persons who have severe egg allergy. Allergic reactions include hives, angioedema, asthma, and systemic anaphylaxis (see CONTRAINDICATIONS).

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.

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.

DRUG INTERACTIONS

Concurrent Use With Other Vaccines

There are no data to assess the concomitant administration of Influenza A (H1N1) 2009 Monovalent Vaccine with other vaccines. If Influenza A (H1N1) 2009 Monovalent Vaccine is to be given at the same time as another injectable vaccine(s), the vaccine(s) should be administered at different injection sites.

Influenza A (H1N1) 2009 Monovalent Vaccine should not be mixed with any other vaccine in the same syringe or vial.

Concurrent Use With Immunosuppressive Therapies

The immunological response to Influenza A (H1N1) 2009 Monovalent Vaccine may be diminished in individuals receiving corticosteroid or immunosuppressive therapies.

Use In Specific Populations

CSL's Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (AFLURIA) are manufactured by the same process. Available information for AFLURIA is provided in this section.

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated in nursing mothers. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine or AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Influenza A (H1N1) 2009 Monovalent Vaccine is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent Vaccine and AFLURIA in children below 6 months of age have not been established. The safety and immunogenicity of AFLURIA was evaluated in 298 children between the ages of 6 months and 9 years (see ADVERSE REACTIONS and Clinical Studies).

Geriatric Use

In four clinical studies, 343 subjects ages 65 years and older received AFLURIA. Hemagglutination-inhibiting antibody responses in geriatric subjects were lower after administration of AFLURIA in comparison to younger adult subjects (see Clinical Studies). Adverse event rates were generally similar in frequency to those reported in subjects ages 18 to less than 65 years, although some differences were observed (see ADVERSE REACTIONS).

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/30/2015

Side Effects
Interactions

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