Prepandrix

prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

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This is a summary of the European public assessment report (EPAR) for Prepandrix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prepandrix.

What is Prepandrix?

Prepandrix is a vaccine that is given by injection. It contains parts of influenza (flu) viruses that have been inactivated (killed). Prepandrix contains a flu strain called ‘A/Indonesia/05/2005’ (H5N1).

What is Prepandrix used for?

Prepandrix is a vaccine for use in adults to protect against flu caused by the H5N1 strain (type) of the influenza A virus. Prepandrix is given according to official recommendations.

The vaccine can only be obtained with a prescription.

How is Prepandrix used?

Prepandrix is given by injection into the shoulder or thigh as two 0.5 ml doses, at least three weeks apart. Adults over 80 years of age may need a double dose of the vaccine (one injection into each shoulder).

There are some data with a vaccine containing a similar H5N1 strain that support the use of half-doses (0.25 ml) in children three to nine years of age.

How does Prepandrix work?

Prepandrix is a ‘prepandemic’ vaccine. This is a special type of vaccine that is intended to protect against a strain of flu that may cause a future pandemic. A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world. Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus. Prepandrix has been developed to provide protection against this strain, so that it can be used before or during a flu pandemic.

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Prepandrix contains small amounts of haemagglutinins (proteins from the surface) of the H5N1 virus. The virus has first been inactivated (killed) so that it does not cause any disease. When a person is given the vaccine, the immune system recognises the virus as ‘foreign’ and makes antibodies against it. The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again. This may help to protect against the disease caused by the virus.

Before use, the vaccine is made up by mixing together a suspension that contains the virus particles with an emulsion. The resulting ‘emulsion’ is then injected. The emulsion contains an ‘adjuvant’ (a compound containing oil) to enhance the immune response.

How has Prepandrix been studied?

The main study of Prepandrix included 675 healthy adults and compared the ability of Prepandrix, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity’). The participants received two injections of Prepandrix 21 days apart. The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).

An additional study was also used to support the main study and to demonstrate the vaccine’s safety.

What benefit has Prepandrix shown during the studies?

According to criteria laid down by the CHMP, a prepandemic vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.

The main study showed that Prepandrix containing the adjuvant produced an antibody response that met these criteria. At 21 days after the second injection, over 90% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.

What is the risk associated with Prepandrix?

The most common side effects with Prepandrix (seen in more than 1 patient in 10) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness). For the full list of all side effects reported with Prepandrix, see the package leaflet.

Prepandrix must not be given to people who are hypersensitive (allergic) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate. Vaccination with Prepandrix should be delayed in people who have a severe fever or a sudden infection.

Why has Prepandrix been approved?

The CHMP decided that Prepandrix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Prepandrix

The European Commission granted a marketing authorisation valid throughout the European Union for Prepandrix on 14 May 2008.

For more information about treatment with Prepandrix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Prepandrix : EPAR - Summary for the public BG = bălgarski 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public ES = español 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public CS = čeština 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public DA = dansk 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public DE = Deutsch 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public ET = eesti keel 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public EL = elliniká 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public EN = English 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public FR = français 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public IT = italiano 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public LV = latviešu valoda 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public LT = lietuvių kalba 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public HU = magyar 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public MT = Malti 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public NL = Nederlands 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public PL = polski 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public PT = português 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public RO = română 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public SK = slovenčina 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public SL = slovenščina 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public FI = suomi 17/08/2009 21/05/2013
Prepandrix : EPAR - Summary for the public SV = svenska 17/08/2009 21/05/2013

This EPAR was last updated on 29/01/2016 .

Authorisation details

Product details

Product details for Prepandrix
NamePrepandrix
Agency product numberEMEA/H/C/000822
Active substance

A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)

International non-proprietary name (INN) or common name

prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Therapeutic area Influenza, HumanImmunizationDisease Outbreaks
Anatomical therapeutic chemical (ATC) code J07BB02

Publication details

Publication details for Prepandrix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision12
Date of issue of marketing authorisation valid throughout the European Union14/05/2008

Contact address:

GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium

Product information

Product information

24/09/2015  Prepandrix -EMEA/H/C/000822 -N/0063

Name Language First published Last updated
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016
Prepandrix : EPAR - Product Information SV = svenska 21/12/2009 29/01/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  
Prepandrix : EPAR - All Authorised presentations SV = svenska 17/08/2009  

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation against H5N1 subtype of influenza-A virus.

This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains. 

Prepandrix should be used in accordance with official guidance. 

Assessment History

Authorised

This medicine is approved for use in the European Union