Cold and Flu Resources
Featured Centers
- Eating Out? Cut Calories, Heartburn
- 5 Good Ways to Save Money on Medicine
- 8 Ways to Treat Your Allergies
home > drugs a-z list > afluria (influenza virus vaccine) drug center > afluria (influenza virus vaccine) drug - side effects and drug interactions
Recommended Topic Related To:
Afluria
2009-2010 Inactivated Influenza Vaccine »
The Seasonal Flu Vaccine: What You Need to Know
- Why get vaccinated?
- Inactivated influenza vaccine
- Who should get inactivated influenza vaccine?
- When should I get influenza vaccine?
- Some people should talk with a doctor before getting influenza vaccine.
- What are the risks from inactivated influenza vaccine?
- What if there is a severe reaction?
- The National Vaccine Injury Compensation Program
- How can I learn more?
Why get vaccinated?
Influenza (the “flu”) is a contagious disease.
It is caused by the influenza virus, which can be spread by coughing, sneezing, or nasal secretions.
Other illnesses can have the same symptoms and are often mistaken for influenza. But only an illness caused by the influenza virus is really influenza.
Anyone can get influenza, but rates of infection are highest among children. For mo...
Afluria
|
|
SIDE EFFECTS
Overall Adverse Reactions
Serious allergic reactions, including anaphylactic shock, have been observed during postmarketing surveillance in individuals receiving AFLURIA (influenza virus vaccine) . Administration of CSL's 2010 Southern Hemisphere influenza vaccine [formulated to contain A/California/7/2009 (H1N1), A/Wisconsin/15/2009 (H3N2) and B/Brisbane/60/2008 (B Strain)] has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years (see WARNINGS AND PRECAUTIONS ).
In adults, the most common local (injection-site) adverse reactions observed in clinical studies with AFLURIA (influenza virus vaccine) were tenderness, pain, redness (erythema), and swelling. The most common systemic adverse reactions observed were headache, malaise, and muscle aches (myalgia).
In children, the most common local (injection-site) adverse reactions observed in a clinical study with AFLURIA (influenza virus vaccine) 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 (Studies 1 to 3) and one in a pediatric population (Study 4) (see Clinical Studies). Clinical safety data are provided for two of the adult studies (Studies 1 and 2) and one pediatric study (Study 4). Rates of solicited fever in children from a second pediatric study (Study 5) are also provided.
A US study (Study 1) included 1,357 subjects for safety analysis, ages 18 to less than 65 years, randomized to receive AFLURIA (influenza virus vaccine) (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 (influenza virus vaccine) (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 (influenza virus vaccine) 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 (influenza virus vaccine) . 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 open-label pediatric study (Study 4), 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.
Rates of solicited fever in the seven days following vaccination with the 2009-2010 formulation of AFLURIA (influenza virus vaccine) or another U.S. licensed influenza vaccine (manufactured by Sanofi Pasteur, Inc.) in children 6 months to less than 18 years of age (Study 5) are shown in Table 5.
Table 1: Proportion of Subjects With Solicited Local or Systemic
Adverse Events* Within 5 Days After Administration of AFLURIA (influenza virus vaccine) 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 (influenza virus vaccine) . ; 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 (influenza virus vaccine) or Placebo, Irrespective
of Causality† (Studies 1 and 2, Adult Populations)
| Adverse Event | Study1 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% | 0.4% | 5% |
| Rhinorrhea | 1% | 1% | 5% |
| Pharyngolaryngeal Pain | 3% | 1% | 5% |
| Reactogenicity Event | 3% | 3% | 0% |
| Diarrhea | 2% | 3% | 1% |
| Back Pain | 2% | 0.4% | 2% |
| Upper Respiratory Tract Infection | 2% | 1% | 0.5% |
| Viral Infection | 0.4% | 1% | 0% |
| Lower Respiratory Tract Infection | 0% | 0% | 1% |
| Myalgia | 1% | 1% | 1% |
| Muscle Spasms | 0.4% | 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 (influenza virus vaccine) . § Thimerosal-containing placebo. |
|||
Table 3: Proportion of Subjects With Solicited Local or Systemic
Adverse Events* Within 7 Days After Administration of AFLURIA (influenza virus vaccine) , 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% |
| Fever | 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 (influenza virus vaccine) , 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 | 5.3% | 7.9% | 5.4% | 5.4% |
| Rhinitis | 13.2% | 9.9% | 6.8% | 10.9% |
| Upper Respiratory Tract Infection | 9.9% | 7.3% | 6.1% | 6.1% |
| Irritability | 3.3% | 5.3% | 0.7% | 0.7% |
| Headache | 1.3% | 0.7% | 6.1% | 4.1% |
| Cough | 10.6% | 13.2% | 10.9% | 13.6% |
| Rhinorrhea | 7.3% | 6.0% | 6.8% | 4.8% |
| Teething | 14.6% | 9.9% | 0.0% | 0.0% |
| Vomiting | 5.3% | 2.6% | 2.0% | 2.7% |
| Influenza-like Illness | 13.9% | 10.6% | 6.8% | 3.4% |
| Pyrexia | 2.6% | 9.3% | 2.7% | 4.1% |
| * 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. |
||||
Table 5: Proportion of Subjects With Solicited Fever* Within
7 days of Vaccination with AFLURIA (influenza virus vaccine) or U.S. Licensed Comparator Vaccine (Study
5, Pediatric Population)
| Age Group | |||||||
| 6 months to < 3 years† | 3 to < 5 years‡ | 5 to < 9 years§ | 9 to < 18 years | ||||
| Dose 1 | Dose 2 | Dose 1 | Dose 2 | Dose 1 | Dose 2 | Dose 1 | |
| AFLURIA¶ | 37% | 15% | 32% | 14% | 16% | 0% | 6% |
| Comparator¶ | 14% | 14% | 11% | 16% | 9% | 2% | 4% |
| * Defined as 99.5°F axillary or 100.4°F
orally after first or second vaccination. † Dosage in subjects 6 months to less than 3 years was one or two 0.25 mL doses (depending on vaccination history) one month apart. Group sizes were n=229 for AFLURIA (influenza virus vaccine) dose 1, n=228 for Comparator dose 1, n=96 for AFLURIA (influenza virus vaccine) dose 2, and n=110 for Comparator dose 2. ‡ Dosage in subjects 3 years to less than 5 years was one or two 0.5 mL doses (depending on vaccination history) one month apart. Group sizes were n=91 for AFLURIA (influenza virus vaccine) dose 1, n=90 for Comparator dose 1, n=29 for AFLURIA (influenza virus vaccine) dose 2, and n=25 for Comparator dose 2. § Dosage in subjects 5 years to less than 9 years was one or two 0.5 mL doses (depending on vaccination history) one month apart. Group sizes were n=161 for AFLURIA (influenza virus vaccine) dose 1, n=165 for Comparator dose 1, n=39 for AFLURIA (influenza virus vaccine) dose 2, and n=53 for Comparator dose 2. || Dosage in subjects 9 years to less than 18 years was one 0.5 mL dose. Group sizes were n=254 for AFLURIA (influenza virus vaccine) dose 1 and n=250 for Comparator dose 1. ¶2009-2010 formulation [A/Brisbane/59/2007, IVR-148 (H1N1), A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like strain), and B/Brisbane/60/2008]. |
|||||||
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 (including febrile seizures); encephalopathy, neuritis or neuropathy, transverse myelitis, and GBS
Vascular disorders
Vasculitis with transient renal involvement
Skin and subcutaneous tissue disorders
Other Adverse Reactions Associated With Influenza Vaccination
Anaphylaxis has been reported after administration of AFLURIA (influenza virus vaccine) . 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).
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 AFLURIA (influenza virus vaccine) with other vaccines. If AFLURIA (influenza virus vaccine) is to be given at the same time as another injectable vaccine(s), the vaccine(s) should be administered at different injection sites.
AFLURIA (influenza virus vaccine) should not be mixed with any other vaccine in the same syringe or vial.
Concurrent Use With Immunosuppressive Therapies
The immunological response to AFLURIA (influenza virus vaccine) may be diminished in individuals receiving corticosteroid or immunosuppressive therapies.
Last reviewed on RxList: 12/8/2010
This monograph has been modified to include the generic and brand name in many instances.
Next: Drug Description
Additional Afluria Information
Afluria - User Reviews
Afluria User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Afluria sorted by most helpful.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Women's Health
Find out what women really need.
From WebMD
Afluria
Related Drugs
Health Resources
Related Supplements
Use it Now
Find it Now
Pill Identifier on RxList
- quick,
easy,
concise
Find a Local Pharmacy
- including
24 hour
pharmacies
Updated & New
RxList does not provide medical advice, diagnosis or treatment.