GSK presents new efficacy data for FLUARIX® QUADRIVALENT (Influenza Vaccine) in children 6 months through 35 months of age

Issued: Philadelphia

GSK presented today at the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices meeting that FLUARIX® QUADRIVALENT demonstrated 63.2% efficacy against moderate to severe influenza and 49.8% efficacy against influenza of any severity in children 6 months through 35 months of age.

These results are based on a randomized, observer-blind, non-influenza vaccine-controlled trial that enrolled 12,018 children in five independent cohorts in 13 countries in Asia, Europe, and Central America from 2011 through the end of 2014.

“Children 6 months through 35 months of age are particularly vulnerable to the flu, and the efficacy results from this trial are promising,” said Dr. Leonard Friedland, Vice President, Scientific Affairs and Public Health, GSK Vaccines, who presented the data to the ACIP. “FLUARIX® QUADRIVALENT can help ensure health care provider and parents have the ability to help protect young children against the flu.”

FLUARIX® QUADRIVALENT was immunogenic against all four vaccine strains (i.e., A/H1N1, A/H3N2, B/Victoria and B/Yamagata).

The safety and reactogenicity profile was similar to vaccines used in the same age group. No safety signal was observed.

Additionally, the study found that FLUARIX® QUADRIVALENT reduced healthcare utilization (i.e., antibiotic use, general practitioner visits and emergency department visits) related to confirmed influenza illness.

About seasonal influenza

Seasonal influenza (the “flu”) is a contagious respiratory illness, caused by flu viruses.^[i] There are two main types of flu viruses, A and B, that spread between people and can cause mild to severe illness.^[ii] Most flu activity in the US occurs from October through May, and it usually peaks between December and February.^[iii]

While anyone can get the flu, it can be particularly serious for young children, older people, pregnant women and people with certain health conditions, such as asthma.^[iv] According to the CDC, the best tool available to help protect yourself and those around you against the flu is to get vaccinated. The more people who are vaccinated, the less chance the virus has to spread.^[v] Currently, the CDC recommends that all people over the age of 6 months get vaccinated against the flu annually.^[vi]

For more information about flu, visit www.flu.gov and www.cdc.gov/flu.

About FLUARIX^® QUADRIVALENT 

FLUARIX^® QUADRIVALENT was first approved in 2012 in the U.S. for the prevention of influenza disease in people 3 years of age and older. In 2018, the indication was expanded to children 6 months and older. It is also approved in more than 30 other countries worldwide.

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 aged 6 months and older.

Important Safety Information forFLUARIX^® QUADRIVALENT

Do not administer FLUARIX^® QUADRIVALENT to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX^® QUADRIVALENT should be based on careful consideration of the potential benefits and risks.

Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX^® QUADRIVALENT. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

If 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 FLUARIX^® QUADRIVALENT, the most common solicited local adverse reaction in adults was pain. The most common systemic adverse reactions in adults were muscle aches, headache, and fatigue. In children aged 6 through 35 months, the most common solicited local adverse reactions were pain and redness; the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children 3 through 17 years of age, solicited local adverse reactions were pain, redness, and swelling. In children 3 through five 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 FLUARIX^® QUADRIVALENT may not result in protection in all vaccine recipients.

For the full US Prescribing Information for FLUARIX^® QUADRIVALENT, visit GSKsource.com.

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, please visit www.gsk.com.

_{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. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.}