GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK

GSK has announced the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK.

Issued: London UK

GlaxoSmithKline plc announced today the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. Following a decentralised procedure, Germany’s Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This is the first four-strain influenza vaccine to be approved in a European country for active immunisation of adults and children from three years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. The new four-strain vaccine will be marketed as INFLUSPLIT TETRA* in Germany and FLUARIX TETRA in the UK.

Human influenza virus strains A and B are responsible for causing seasonal flu epidemics globally. Current inactivated influenza vaccines in Europe are designed to provide protection against three strains of influenza virus (referred to as trivalent vaccines). They are composed of two influenza A strains (A/H1N1 and A/H3N2) and one B strain lineage, as recommended by the World Health Organization and its partners as the predominant strains in circulation for a given flu season. Currently there are 4 major strains of Influenza circulating, two influenza A strains (A/H1N1 and A/H3N2) and two B strain lineage (B-Victoria and B-Yamagata). As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine (referred to as vaccine ‘mismatch’).

INFLUSPLIT TETRA/FLUARIX TETRA have been developed to provide broader influenza strain coverage by the addition of a second B strain; thereby providing coverage against two influenza A strains and two influenza B strains. The vaccine is expected to help protect against four of the predominant strains of influenza circulating, thus potentially reducing the overall influenza related burden of disease. 

INFLUSPLIT TETRA/FLUARIX TETRA is expected to be available for use in Germany and the UK in time for the 2013/2014 flu season. This vaccine was approved by the US Food and Drug Administration (FDA) in December 2012 (as FLUARIX QUADRIVALENT). GSK has also submitted licence applications for this vaccine in Australia, Switzerland and Taiwan. Regulatory decisions for these countries are expected over the coming months.

About Seasonal Influenza

  • Influenza is an acute viral infection that spreads easily from person to person, causing serious illness and death and is a serious public health issue. The most common symptoms of the disease are chills, fever, sore throat, muscle pains, severe headache, coughing, and weakness/fatigue1.
  • Yearly outbreaks of influenza affect all age groups, but the highest risk of complications occurs in children younger than two years of age, the elderly (65 years and older) and those with particular medical conditions (e.g., chronic lung, liver, heart, kidney, blood or metabolic diseases)1.
  • The World Health Organization (WHO) estimates that annual epidemics can be responsible for three to five million cases of severe illness and up to 500,000 deaths per year worldwide1.

Further information about seasonal influenza can be found at:


INFLUSPLIT TETRA/FLUARIX TETRA is indicated for active immunization of adults and children from 3 years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.

  • INFLUSPLIT TETRA/FLUARIX TETRA is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains.  As with any vaccine, a protective immune response may not be elicited in all vaccinees.
  • Hypersensitivity to the active substances, to any of the excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate is a contraindication.
  • Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
  • In two clinical studies, healthy adults 18 years of age and older and healthy children 3 to 17 years of age were administered INFLUSPLIT TETRA/FLUARIX TETRA (more than 3,000 adults and 900 children) or GlaxoSmithKline’s trivalent influenza vaccine, FLUARIX™ (more than 1,000 adults and 900 children). Similar rates of solicited adverse events were observed in recipients of INFLUSPLIT TETRA/FLUARIX TETRA and FLUARIX™. In all age groups the most frequently reported local adverse reaction after vaccination was injection site pain (36.4% to 40.9%). Very common adverse reactions (=1/10) include irritability (reported as a solicited symptom in subjects less than 6 years of age), myalgia, injection site pain, and fatigue.  
  • Post-marketing data: There has been no post-marketing exposure to INFLUSPLIT TETRA/FLUARIX TETRA. However, as all three of the influenza strains contained in FLUARIX™ are included in INFLUSPLIT TETRA/FLUARIX TETRA, the following adverse events that have been observed for FLUARIX™ during post-marketing surveillance may occur in patients receiving INFLUSPLIT™ TETRA post-approval. All of these adverse events are classified as rare (=1/10,000 to
  • Blood and lymphatic system disorders: transient lymphadenopathy
  • Immune system disorders: allergic reactions (including anaphylactic reactions)
  • Nervous system disorders: neuritis, acute disseminated encephalomyelitis, Guillain-Barré syndrome*

*Spontaneous reports of Guillain-Barré syndrome have been received following vaccination with FLUARIX; however, a causal association between vaccination and Guillain-Barré syndrome has not been established.

  • Skin and subcutaneous tissue disorders: urticaria, pruritus, erythema, angioedoema
  • General disorders and administration site conditions: influenza-like illness, malaise

Overdosage is unlikely to have any untoward effect.

Detailed information on the use of INFLUSPLIT TETRA/FLUARIX TETRA and its safety profile are described in the Summary of Product Characteristics, which is expected to be published on the PEI website ( vaccines) and on the Electronic Medicines Compendium (

About GlaxoSmithKline Vaccines

GlaxoSmithKline Vaccines is active in vaccine research and development. Headquartered in Belgium, GSK Vaccines has 13 manufacturing sites strategically positioned around the globe. Of the 883 million doses of our vaccines we distributed in 2012, over 80% went to developing countries, which include the least developed, low- and middle-income countries.

GlaxoSmithKline – 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

GlaxoSmithKline Enquiries:


UK Media enquiries:

David Mawdsley

+44 (0) 20 8047 5502



Sarah Spencer

+44 (0) 20 8047 5502



David Daley

+44 (0) 20 8047 5502



Catherine Hartley

+44 (0) 20 8047 5502






US Media enquiries:

Stephen Rea

+1 215 751 4394



Kevin Colgan

+1 919 483 2933

(North Carolina)


Melinda Stubbee

+1 919 483 2510

(North Carolina)


Mary Anne Rhyne

+1 919 483 0492

(North Carolina)


Sarah Alspach

+1 202 715 1048

(Washington, DC)


Jennifer Armstrong

+1 215 751 5664




Analyst/Investor enquiries:

Ziba Shamsi

+ 44 (0) 20 8047 3289



Lucy Budd

+44 (0) 20 8047 2248



Tom Curry

+ 1 215 751 5419



Gary Davies

+ 44 (0) 20 8047 5503



James Dodwell

+ 44 (0) 20 8047 2406



Jeff McLaughlin

+ 1 215 751 7002


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.

INFLUSPLIT TETRA, FLUARIX TETRA, FLUARIX QUADRIVALENT and FLUARIX are trademarks of the GlaxoSmithKline group of companies.


1.     World Health Organization. Influenza (seasonal) factsheet.