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

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

PR Newswire

PHILADELPHIA, Dec. 11, 2013

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 3years 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
3years of age and older.

Important Safety Information for FluLaval Quadrivalent and Fluarix
Quadrivalent

  oDo 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.
  oIf 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.
  oThe tip caps of the Fluarix Quadrivalent prefilled syringes may contain
    natural rubber latex which may cause allergic reactions in latex-sensitive
    individuals.
  oSyncope (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
  oIf 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.
  oIn 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 4years
    of age, the most commonsolicited systemic adverse reactions were
    irritability, drowsiness, and loss of appetite. In children 5 through
    17years 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).
  oIn 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 17years of age, injection site adverse reactions were
    pain, redness, and swelling. In children 3 through 5years of age, the
    most commonsystemic adverse reactions were drowsiness, irritability, and
    loss of appetite. In children 6 through 17years 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).
  oVaccination 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
tous.gsk.com, follow us ontwitter.com/GSKUSor visit
ourblog(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

Website: http://us.gsk.com
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