ProQuad

measles, mumps, rubella and varicella vaccine (live)

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This is a summary of the European public assessment report (EPAR) for ProQuad. 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 ProQuad.

What is ProQuad?

ProQuad is a vaccine against measles, mumps, rubella, and varicella (chickenpox). ProQuad is available as a powder and solvent that are made up into a suspension for injection. The active substances are attenuated (weakened) viruses for the diseases.

What is ProQuad used for?

ProQuad is given to children from 12 months of age to help protect them against the four diseases: measles, mumps, rubella, and chickenpox. ProQuad may also be given to children from nine months of age in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.

The vaccine can only be obtained with a prescription.

How is ProQuad used?

ProQuad is used according to official recommendations, including the number of doses and the interval between them.

For children above 12 months of age, one ProQuad injection is sufficient to provide optimal protection against measles, mumps and rubella. To protect against chickenpox, a second injection is needed, given one to three months after the first one; this can be done either by giving a second dose of ProQuad, or by giving a dose of another vaccine that only protects against chickenpox.

Children between nine and 12 months of age should receive a second dose at least three months after the first dose to ensure that they are adequately protected against measles and chickenpox.

The vaccine is injected into a muscle or under the skin, preferably in the thigh in younger children and in the shoulder area in older children and adults. It is only given under the skin in patients with low levels of platelets in the blood or other bleeding disorders, as they may experience bleeding if the vaccine is injected into a muscle.

How does ProQuad work?

ProQuad is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. ProQuad contains weakened forms of the viruses that cause measles, mumps, rubella and chickenpox. When a person is given the vaccine, the immune system recognises the weakened viruses as ‘foreign’ and makes defences against them. In the future, the immune system will be able to respond more quickly when it is exposed to the viruses again. This will help to protect against the diseases caused by these viruses.

How has ProQuad been studied?

Because ProQuad contains well known weakened viruses, which are already used in other vaccines, the company presented data from vaccines that are already on the market. The main studies were carried out to look at the ability of one or two doses of the vaccine to trigger an immune response in 5,446 healthy children (aged 12 to 23 months). ProQuad was compared with its ‘component vaccines’, a triple vaccine against mumps, measles and rubella, and a vaccine against chickenpox. Another study also looked at the responses one year after vaccination in 2,108 children.

A study has also been carried out with ProQuad in 1,620 children who received the first dose at 9, 11 and 12 months of age, and the second dose three months later. This study looked at the ability of the vaccine to trigger immune responses in these age groups.

What benefit has ProQuad shown during the studies?

The response rates in children above 12 months of age (measuring how the immune system had responded to the viruses) were: 98% for measles, 96% to 99% for mumps, 96% for rubella and 91% for chickenpox. After the second dose, the rates were around 99% for measles, 100% for mumps, 98% for rubella, and 99% for chickenpox.

The study in children from nine to 12 months of age showed that, after two doses of ProQuad, the immune response against mumps, rubella and chickenpox in children who received the first dose at nine months of age was comparable with those who received the first dose at 12 months of age. However, children who received the first dose at nine months of age had a lower immune response against measles.

What is the risk associated with ProQuad?

The most common side effect with ProQuad (seen in more than 1 patient in 10) are fever, and pain and erythema (redness) at the site of injection. For the full list of all side effects reported with ProQuad, see the package leaflet.

ProQuad must not be used in children who are hypersensitive (allergic) to any chickenpox vaccine or measles, mumps or rubella vaccine, to any of the other ingredients, or to neomycin. It must not be used in children who have severely weakened immune systems. It must also not be used in a pregnant woman. For the full list of restrictions, see the package leaflet.

Why has ProQuad been approved?

The CHMP decided that ProQuad’s benefits are greater than its risks and recommended that it be given marketing authorisation for use in children above 12 months of age, noting that a second vaccination against chickenpox should be given for full protection against the disease.

The Committee also recommended that the vaccine be authorised in children from nine to 12 months of age only in certain situations, for example as part of a national vaccination programme, during an outbreak or for travel to a region where measles is common.

Other information about ProQuad

The European Commission granted a marketing authorisation valid throughout the European Union for ProQuad on 6 April 2006.

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

Name Language First published Last updated
ProQuad : EPAR - Summary for the public BG = bălgarski 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public ES = español 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public CS = čeština 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public DA = dansk 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public DE = Deutsch 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public ET = eesti keel 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public EL = elliniká 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public EN = English 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public FR = français 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public IT = italiano 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public LV = latviešu valoda 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public LT = lietuvių kalba 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public HU = magyar 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public MT = Malti 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public NL = Nederlands 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public PL = polski 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public PT = português 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public RO = română 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public SK = slovenčina 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public SL = slovenščina 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public FI = suomi 02/06/2006 12/02/2014
ProQuad : EPAR - Summary for the public SV = svenska 02/06/2006 12/02/2014

This EPAR was last updated on 26/01/2016 .

Authorisation details

Product details

Product details for ProQuad
NameProQuad
Agency product numberEMEA/H/C/000622
Active substance

virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella

International non-proprietary name (INN) or common name

measles, mumps, rubella and varicella vaccine (live)

Therapeutic area MumpsChickenpoxRubellaImmunizationMeasles
Anatomical therapeutic chemical (ATC) code J07BD04

Publication details

Publication details for ProQuad
Marketing-authorisation holder

Sanofi Pasteur MSD, SNC

Revision20
Date of issue of marketing authorisation valid throughout the European Union06/04/2006

Contact address:

Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès 
69007 Lyon 
France

Product information

Product information

16/12/2015  ProQuad -EMEA/H/C/000622 -R/0100

Name Language First published Last updated
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016
ProQuad : EPAR - Product Information SV = svenska 12/08/2009 26/01/2016

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
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014
ProQuad : EPAR - All Authorised presentations SV = svenska 24/08/2006 12/02/2014

Pharmacotherapeutic group

Vaccines

Therapeutic indication

ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age.

ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
ProQuad : EPAR - Procedural steps taken before authorisation SV = svenska 02/06/2006  
ProQuad : EPAR - Scientific Discussion SV = svenska 02/06/2006  

Authorised

This medicine is approved for use in the European Union

More information on ProQuad