Hexyon

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

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This is a summary of the European public assessment report (EPAR) for Hexyon. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Hexyon.

For practical information about using Hexyon, patients should read the package leaflet or contact their doctor or pharmacist.

What is Hexyon and what is it used for?

Hexyon is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis-B virus, and inactivated polioviruses. It is used in children aged from six weeks to two years to protect against the following infectious diseases:

  • diphtheria (a highly contagious disease that affects the throat and skin, and can cause damage to the heart and other organs);
  • tetanus (lockjaw, usually caused by infection of a wound);
  • pertussis (whooping cough);
  • hepatitis B (a viral liver infection);
  • poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
  • invasive diseases (such as meningitis) caused by H. influenzae type-b bacteria (Hib).
How is Hexyon used?

Hexyon is available as a suspension for injection in vials and prefilled syringes. It can only be obtained with a prescription. Vaccination with Hexyon should be carried out according to official recommendations. The recommended initial vaccination schedule is either two doses, given 2 months apart or three doses, given at least one month apart. A booster dose should be given at least six months after the last of these initial doses. Hexyon or an appropriate combination of other vaccines can be used for the booster dose. Hexyon is given by deep injection into a muscle, normally in the upper thigh or the shoulder.

For further information, see the package leaflet.

How does Hexyon work?

Hexyon is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against diseases. Hexyon contains small amounts of:

  • toxoids (chemically inactivated toxins) from the bacteria that cause diphtheria and tetanus;
  • toxoids and other proteins purified from B. pertussis;
  • surface antigen (protein from the surface) of the hepatitis-B virus;
  • polioviruses (types 1, 2 and 3) that have been inactivated (killed) so they do not cause any disease;
  • polysaccharides (sugars) extracted from the ‘capsules’ that surround the Hib bacteria. The polysaccharides are chemically attached (conjugated) to tetanus toxoid as a carrier protein because this improves the response to the vaccine.

When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses. This helps to protect against the diseases that these bacteria and viruses cause.

The vaccine is ‘adsorbed’. This means that some of the active substances are fixed onto aluminium compounds, to stimulate a better response. The surface protein of the hepatitis-B virus is produced by a method known as ‘recombinant DNA technology’: it is made by yeast cells that have received a gene (DNA), which makes them able to produce the protein.

What benefits of Hexyon have been shown in studies?

Hexyon has been studied in several countries worldwide in 12 main studies involving over 3,400 infants between six weeks and two years of age who were given three doses of the vaccine during their first six months of life according to different local vaccination schedules. The effects were compared with a combination of separate vaccines designed to protect against the diseases included in Hexyon. The main measure of effectiveness was the production of antibody levels known to be protective against those diseases.

Five of these studies examined the effect of giving a booster dose at least 6 months after the initial vaccination schedule in 1,511 children. The studies showed that protective antibody levels against the various diseases developed in between 90 and 100% of children after the first three doses of Hexyon; protection was maintained or improved when a booster dose was given.

A subsequent study involving 455 children looked at the longer-term persistence of protective antibodies up to 3 years after a booster dose with Hexyon, and another study in 1336 infants evaluated the response to different lots of the vaccine and what happened when it was given with vaccines for infections caused by the bacterium Streptococcus pneumoniae (Prevenar) and rotavirus (Rotarix). These studies showed that Hexyon produces similar antibody profiles over time to comparable vaccines, and that the vaccine can be given at the same time as Prevenar and Rotarix.

The two-dose vaccination schedule was investigated in an additional main study involving 554 children. In the study, children who either received Hexyon produced a similar antibody response to those who received a comparator vaccine (Infanrix hexa), when given as a two-dose schedule followed by a booster 6 months later.

What are the risks associated with Hexyon?

The most common side effects with Hexyon include pain and redness at the site of injection, irritability and crying. Reactions may be more likely after the first dose than later doses. For the full list of all side effects reported with Hexyon, see the package leaflet.

Hexyon must not be used in children who have ever had encephalopathy (brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past. It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy (fits), unless the condition has stabilised with treatment and the benefit clearly outweighs the risk. Vaccination with Hexyon should be postponed if a child has a moderate to severe fever. For the full list of restrictions, see the package leaflet.

Why is Hexyon approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Hexyon’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that Hexyon has been shown to produce protective antibody levels against diphtheria, tetanus, pertussis, hepatitis-B virus, polioviruses and Hib, regardless of ethnicity. Although vaccination with Hexyon is more likely than similar vaccines to cause reactions (mainly at the injection site), the CHMP considered that overall its safety profile is similar to other vaccines. The CHMP noted that more information is needed on the effects of Hexyon in children with weakened immune systems. The company has undertaken to carry out further studies.

What measures are being taken to ensure the safe and effective use of Hexyon?

A risk-management plan has been developed to ensure that Hexyon is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hexyon, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Hexyon

The European Commission granted a marketing authorisation valid throughout the European Union for Hexyon on 17 April 2013.

Name Language First published Last updated
Hexyon : EPAR - Summary for the public BG = bălgarski 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public ES = español 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public CS = čeština 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public DA = dansk 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public DE = Deutsch 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public ET = eesti keel 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public EL = elliniká 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public EN = English 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public FR = français 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public IT = italiano 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public LV = latviešu valoda 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public LT = lietuvių kalba 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public HU = magyar 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public MT = Malti 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public NL = Nederlands 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public PL = polski 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public PT = português 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public RO = română 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public SK = slovenčina 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public SL = slovenščina 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public FI = suomi 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public SV = svenska 12/07/2013 15/04/2015
Hexyon : EPAR - Summary for the public HR = Hrvatski 12/07/2013 15/04/2015

This EPAR was last updated on 06/06/2016 .

Authorisation details

Product details

Product details for Hexyon
NameHexyon
Agency product numberEMEA/H/C/002796
Active substance

diphtheria toxoid / tetanus toxoid / two-component acellular pertussis (pertussis toxoid and filamentous haemagglutinin) / inactivated poliomyelitis virus types 1, 2 and 3 / Haemophilus influenzae type-b polysaccharide (polyribosylribitol phosphate) conjugated to tetanus protein / hepatitis-B surface antigen

International non-proprietary name (INN) or common name

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type-b conjugate vaccine (adsorbed)

Therapeutic area Meningitis, HaemophilusHepatitis BDiphtheriaPoliomyelitisWhooping CoughImmunizationTetanus
Anatomical therapeutic chemical (ATC) code J07CA09
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Hexyon
Marketing-authorisation holder

Sanofi Pasteur MSD SNC

Revision10
Date of issue of marketing authorisation valid throughout the European Union17/04/2013

Contact address:

Sanofi Pasteur MSD SNC
162 avenue Jean Jaurès
69007 Lyon
France

Product information

Product information

01/04/2016  Hexyon -EMEA/H/C/002796 -WS/0789

Name Language First published Last updated
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 29/01/2016
Hexyon : EPAR - Product Information HR = Hrvatski 12/07/2013 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
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015
Hexyon : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 02/03/2015

Pharmacotherapeutic group

Vaccines, bacterial and viral vaccines combined

Therapeutic indication

Primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Hexyon : EPAR - Public assessment report HR = Hrvatski 12/07/2013  
CHMP summary of positive opinion for Hexyon HR = Hrvatski 22/02/2013  

Authorised

This medicine is approved for use in the European Union