Vaxelis

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

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

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

What is Vaxelis and what is it used for?

Vaxelis 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 babies and toddlers aged from six weeks 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 pneumonia and meningitis) caused by H. influenzae type-b bacteria (Hib).
How is Vaxelis used?

Vaxelis is available in pre-filled syringes as a suspension for injection. It can only be obtained with a prescription. Vaccination with Vaxelis should be carried out according to official recommendations.

The recommended initial vaccination schedule is either two or three doses, given at least one month apart to children aged over six weeks. A booster dose should be given at least six months after the last of these initial doses. Vaxelis or an appropriate combination of other vaccines can be used for the booster dose. Vaxelis is given by injection into a muscle, normally in the upper thigh or the shoulder.

For further information, see the summary of product characteristics (also part of the EPAR).

How does Vaxelis work?

Vaxelis is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) to defend itself against diseases. Vaxelis contains small amounts of materials derived from the viruses and bacteria it protects against.

When a child is given the vaccine, the immune system recognises the materials from the bacteria and viruses as foreign and makes antibodies against them. The immune system will then be able to produce antibodies 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’ on aluminium compounds. This means that some of the active substances are fixed onto minute particles of aluminium compounds. This improves the ability to produce antibodies.

What benefits of Vaxelis have been shown in studies?

Vaxelis has been studied in two main studies involving more than 2,500 infants and toddlers over six weeks of age who were given either two or three doses of the vaccine during their first six months of life. They then received a booster dose shortly after their first birthday. The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, designed to protect against the same six diseases as Vaxelis. In these studies, children also received other vaccines according to local vaccination schedules to protect against other childhood diseases such as rotavirus gastroenteritis, measles, mumps, rubella and varicella. The main measure of effectiveness was the production of antibody levels known to be protective against diphtheria, tetanus, poliomyelitis, hepatitis B and H. influenzae type b infections and expected to protect against pertussis.

Both studies showed that Vaxelis produces satisfactory levels of antibodies to protect against all of these six diseases in between 90 and 100% of children who completed the course of vaccination with Vaxelis.

What are the risks associated with Vaxelis?

The most common side effects with Vaxelis include pain, swelling and redness at the site of injection, irritability, crying, sleepiness, fever, reduced appetite and vomiting. For the full list of all side effects reported with Vaxelis, see the package leaflet.

Vaxelis must not be used in children who have ever had an allergic reaction to Vaxelis or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin). It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components. 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 of vaccination clearly outweighs the risk. For the full list of restrictions, see the package leaflet.

Why is Vaxelis approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Vaxelis’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that Vaxelis has been shown to produce satisfactory antibody levels against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses and Hib. These antibody levels have been previously shown to protect against these diseases. With regard to safety, the CHMP considered that overall its safety profile is similar to other vaccines.

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

A risk management plan has been developed to ensure that Vaxelis 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 Vaxelis, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Vaxelis

The European Commission granted a marketing authorisation valid throughout the European Union for Vaxelis on 15 February 2016.

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

Name Language First published Last updated
Vaxelis : EPAR - Summary for the public BG = bălgarski 26/02/2016  
Vaxelis : EPAR - Summary for the public ES = español 26/02/2016  
Vaxelis : EPAR - Summary for the public CS = čeština 26/02/2016  
Vaxelis : EPAR - Summary for the public DA = dansk 26/02/2016  
Vaxelis : EPAR - Summary for the public DE = Deutsch 26/02/2016  
Vaxelis : EPAR - Summary for the public ET = eesti keel 26/02/2016  
Vaxelis : EPAR - Summary for the public EL = elliniká 26/02/2016  
Vaxelis : EPAR - Summary for the public EN = English 26/02/2016  
Vaxelis : EPAR - Summary for the public FR = français 26/02/2016  
Vaxelis : EPAR - Summary for the public IT = italiano 26/02/2016  
Vaxelis : EPAR - Summary for the public LV = latviešu valoda 26/02/2016  
Vaxelis : EPAR - Summary for the public LT = lietuvių kalba 26/02/2016  
Vaxelis : EPAR - Summary for the public HU = magyar 26/02/2016  
Vaxelis : EPAR - Summary for the public MT = Malti 26/02/2016  
Vaxelis : EPAR - Summary for the public NL = Nederlands 26/02/2016  
Vaxelis : EPAR - Summary for the public PL = polski 26/02/2016  
Vaxelis : EPAR - Summary for the public PT = português 26/02/2016  
Vaxelis : EPAR - Summary for the public RO = română 26/02/2016  
Vaxelis : EPAR - Summary for the public SK = slovenčina 26/02/2016  
Vaxelis : EPAR - Summary for the public SL = slovenščina 26/02/2016  
Vaxelis : EPAR - Summary for the public FI = suomi 26/02/2016  
Vaxelis : EPAR - Summary for the public SV = svenska 26/02/2016  
Vaxelis : EPAR - Summary for the public HR = Hrvatski 26/02/2016  
Name Language First published Last updated
Vaxelis : EPAR - Risk-management-plan summary (English only) 26/02/2016  

This EPAR was last updated on 26/02/2016 .

Authorisation details

Product details

Product details for Vaxelis
NameVaxelis
Agency product numberEMEA/H/C/003982
Active substance

Diphtheria toxoid / tetanus toxoid / Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3 / hepatitis B surface antigen produced in yeast cells / poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.

International non-proprietary name (INN) or common name

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

Therapeutic area Meningitis, HaemophilusHepatitis BWhooping CoughDiphtheriaPoliomyelitisTetanus
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 Vaxelis
Marketing-authorisation holder

Sanofi Pasteur MSD SNC

Revision0
Date of issue of marketing authorisation valid throughout the European Union15/02/2016

Contact address:

Sanofi Pasteur MSD SNC 
162 avenue Jean Jaures 
69007 Lyon 
France

Product information

Product information

15/02/2016  Vaxelis -EMEA/H/C/003982 --

Name Language First published Last updated
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  
Vaxelis : EPAR - Product Information EN = English 26/02/2016  

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
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  
Vaxelis : EPAR - All Authorised presentations EN = English 26/02/2016  

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Vaxelis : EPAR - Public assessment report EN = English 26/02/2016  
CHMP summary of opinion for Vaxelis EN = English 17/12/2015  

Authorised

This medicine is approved for use in the European Union