influenza virus vaccine
Specific levels of hemagglutination-inhibition (HI) antibody titer post-vaccination with inactivated influenza virus vaccines have not been correlated with protection from influenza illness but the HI antibody titers have been used as a measure of vaccine activity.
FLUARIX is indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLUARIX is approved for use in persons aged 6 months and older.
FLUARIX is an injectable suspension. A single dose is 0.5 mL.
In adults who received FLUARIX in a randomized, placebo-controlled study, the most common (≥10%) solicited local adverse reactions were pain (55%) and redness (18%). The most common systemic adverse reactions were muscle aches (23%), fatigue (20%), and headache (19%).
In children aged 3 through 4 years who received FLUARIX, the most common (≥10%) solicited local adverse reactions were pain (35%), redness (23%), and swelling (14%). The most common systemic adverse reactions were irritability (21%), loss of appetite (13%), and drowsiness (13%).
Do not administer FLUARIX to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine
If Guillain‑Barré syndrome (GBS) has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX should be based on careful consideration of the potential benefits and risks.
Other risks include, syncope, potential anaphylactic reactions, altered immunocompetence, limitations of vaccine effectiveness.
FLUARIX, Influenza Vaccine, is a sterile colorless and slightly opalescent injectable suspension for intramuscular use. FLUARIX is a vaccine prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde leading to the production of a “split virus.” Each split inactivated virus is then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The vaccine is formulated from the 3 split inactivated virus solutions.