New England Journal of Medicine releases study showing GSK's FluLaval Quadrivalent vaccine effective in preventing seasonal flu in children

PHILADELPHIA, Dec. 11, 2013 /PRNewswire/ -- GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that a peer-reviewed study issued online by the New England Journal of Medicine has reported that GSK's FluLaval^® Quadrivalent reduced flu cases among children ages 3-8 by 55.4% overall and lowered the risk of developing moderate-to-serious flu illness by 73.1%^[1]. This was the first large-scale clinical trial conducted specifically to review the safety and effectiveness of vaccinating children with a four-strain flu vaccine. The randomized, controlled clinical trial included 5,220 children and was one of the pivotal studies leading to the recent approval of FluLaval Quadrivalent by the U.S. Food and Drug Administration.

"The U.S. Centers for Disease Control recommends all children get vaccinated each flu season.  This is in response to how many children require flu-related medical care, and given that as many as 20,000 U.S. children are hospitalized each year due to complications of the flu," said Leonard Friedland, M.D., Vice President, Director Scientific Affairs and Public Health, GSK Vaccines North America.  "This study provides robust safety and efficacy data on FluLaval Quadrivalent, and evidence of the clinical benefit of vaccination with FluLaval Quadrivalent as demonstrated by the prevention of moderate-to-severe cases of influenza among children." 

Newly available quadrivalent flu vaccines protect against all four of the flu strains that are in circulation during a flu season.  Until this flu season, flu vaccines were limited to protecting against three influenza strains, and this necessitated the World Health Organization and other public health authorities to estimate each year what three strains might be predominant.

Virus strains that scientists refer to as A-strains traditionally cause the most cases of flu, so two A strains have been included in seasonal flu vaccines.  The other circulating strains, referred to as B-strains, derive from two distinct strain lineages.  In six of the past 11 flu seasons, the B-strain included in flu vaccines was not the predominant B-strain in circulation.  The new quadrivalent flu vaccines protect against both B strains, providing the broadest strain protection currently available.

GSK has developed two quadrivalent vaccines that the U.S. Food and Drug Administration have licensed for use.  GSK markets these vaccines as FluLaval^® Quadrivalent and Fluarix^® Quadrivalent. Both vaccines are approved to be administered to individuals three years and older, and they have been shown to have comparable safety and tolerability to three-strain (trivalent) seasonal influenza vaccines.  Complete prescribing information for both vaccines is available at us.gsk.com.

About Seasonal Influenza

Seasonal influenza may cause three to five million cases of severe illness and up to 500,000 deaths per year worldwide.  Vaccination against influenza is considered one of the most effective ways of preventing mortality, complications and hospitalizations.  The U.S. Centers for Disease Control and Prevention (CDC) recommends that children six months of age and older and adults receive an influenza shot annually.  More information about seasonal influenza can be found at http://flu.gov and http://www.cdc.gov/flu/about/season/flu-season-2012-2013.htm.

Indication for FluLaval Quadrivalent

FluLaval Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  FluLaval Quadrivalent is approved for use in persons 3 years of age and older.

Indication for Fluarix Quadrivalent

Fluarix Quadrivalent is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  Fluarix Quadrivalent is approved for use in persons 3 years of age and older.

Important Safety Information for FluLaval Quadrivalent and Fluarix Quadrivalent

• Do not administer FluLaval Quadrivalent or Fluarix Quadrivalent to anyone with known severe allergic reactions (anaphylaxis) to any component of the vaccine, including egg protein, or a life‐threatening reaction to previous administration of any influenza vaccine.
• If Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FluLaval Quadrivalent or Fluarix Quadrivalent should be based on careful consideration of the potential benefits and risks.
• The tip caps of the Fluarix Quadrivalent prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
• Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
• If FluLaval Quadrivalent or Fluarix Quadrivalent is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons.
• In clinical trials with FluLaval Quadrivalent, the most common solicited local adverse reaction in adults was pain.  The most common solicited systemic adverse reactions in adults were muscle aches, headache, fatigue and arthralgia.  In children 3 through 17 years of age, the most common solicited local adverse reaction was pain.  In children 3 through 4 years of age, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite.  In children 5 through 17 years of age, the most common solicited systemic adverse reactions were muscle aches, fatigue, headache, arthralgia, and gastrointestinal symptoms.  (See Adverse Reactions section of the Prescribing Information for FluLaval Quadrivalent for other potential adverse reactions and events).
• In clinical trials with Fluarix Quadrivalent, the most common injection site adverse reaction in adults was pain.  The most common systemic adverse reactions in adults were muscle aches, headache, and fatigue.  In children 3 through 17 years of age, injection site adverse reactions were pain, redness, and swelling. In children 3 through 5 years of age, the most common systemic adverse reactions were drowsiness, irritability, and loss of appetite.  In children 6 through 17 years of age, the most common systemic adverse reactions were fatigue, muscle aches, headache, arthralgia, and gastrointestinal symptoms.  (See Adverse Reactions section of the Prescribing Information for Fluarix Quadrivalent for other potential adverse reactions and events).
• Vaccination with FluLaval Quadrivalent or Fluarix Quadrivalent may not result in protection in all vaccine recipients.

GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information go to us.gsk.com, follow us on twitter.com/GSKUS or visit our blog(www.morethanmedicine.us.gsk.com/blog/). 

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

^[1] Moderately severe influenza was defined as fever greater than 39°C or physician-confirmed acute otitis media or lower respiratory illness (shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup) or serious extra-pulmonary complication including myositis, encephalitis, seizure, or myocarditis.

SOURCE GlaxoSmithKline plc