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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/272118/2011

EMEA/H/C/000604

EPAR summary for the public

M-M-RVAXPRO

measles, mumps and rubella vaccine (live)

This document is a summary of the European public assessment report (EPAR) for M-M-RVAXPRO. 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 M-M-RVAXPRO.

What is M-M-RVAXPRO?

M-M-RVAXPRO is a vaccine that contains live attenuated (weakened) measles, mumps and rubella viruses. It is available as a powder and solvent that are made up into a suspension for injection.

What is M-M-RVAXPRO used for?

M-M-RVAXPRO is used to vaccinate against measles, mumps, and rubella (German measles) in adults and children aged 12 months or older. Under some special circumstances, it can also be used in babies as young as nine months.

The vaccine can only be obtained with a prescription.

How is M-M-RVAXPRO used?

M-M-RVAXPRO is given according to official recommendations. It is given as one dose injected into a muscle or under the skin, preferably in the thighs of younger children and around the shoulder in older children and adults.. For people with thrombocytopenia (low blood platelet counts) or any problems with blood clotting, the vaccine should only be injected under the skin to avoid bleeding. People who did not respond to the first dose can be given a second dose after at least four weeks.

Babies between nine and 12 months can be given the vaccine if they are considered to be at special risk, for example, if there is an outbreak in a day-care or the baby is travelling to an area where

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measles is common. They should be re-vaccinated at between 12 and 15 months. They may also be given an additional vaccination against measles.

How does M-M-RVAXPRO work?

M-M-RVAXPRO is a vaccine. Vaccines work by 'teaching' the immune system (the body's natural defences) how to defend itself against a disease. M-M-RVAXPRO contains small amounts of weakened forms of the viruses that cause measles, mumps, and rubella. When a person is given the vaccine, the immune system recognises the weakened viruses as 'foreign' and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these viruses. This will help to protect against diseases caused by these viruses.

M-M-RVAXPRO is very similar to another vaccine for the measles, mumps and rubella vaccine already authorised (M-M-R II) but with a slight difference. Both vaccines contain very small amounts of a protein (albumin) that is used in the manufacturing process. While the albumin in M-M-R-II is extracted from human blood, the albumin in M-M-RVAXPRO is obtained using 'recombinant DNA technology' (a technique where a yeast is given a gene (DNA) that makes it able to produce the protein).

How has M-M-RVAXPRO been studied?

Three main studies were carried out with M-M-RVAXPRO. The first study, which involved 1,279 children, compared M-M-RVAXPRO with a similar vaccine that used albumin from human blood in its production. This study looked at the ability of the vaccine when injected under the skin, to trigger the production of antibodies against the viruses ('immunogenicity'). A second study in 1,997 children looked specifically at mumps, to see if M-M-RVAXPRO when injected under the skin provided enough protection against the disease. A third study in 776 children compared the effects of M-M-RVAXPRO when given as injected into the muscle and when injected under the skin.

A fourth study was carried out with ProQuad (a vaccine that contains similar weakened viruses to those of M-M-RVAXPRO) given as two doses. The study compared the immune response of babies aged nine or 11 months at the time of the first dose with that of babies aged 12 months. A total of 1,620 babies took part in this study.

What benefit has M-M-RVAXPRO shown during the studies?

In the first study, M-M-RVAXPRO triggered the same level of immune response as the comparator. For both vaccines, the proportion of patients with sufficient amount of antibodies against the three viruses was around 98% or higher. The second study also showed that M-M-RVAXPRO triggered the production of sufficient amounts of antibodies against mumps. The third study showed that the immune response triggered by M-M-RVAXPRO was the same regardless of whether it was injected into a muscle or under the skin. The fourth study showed that, after the second dose, the production of antibodies against mumps, and rubella was similar among babies who started vaccination at nine, 11 and 12 months. However, the immune response for measles was lower in babies who started vaccination at nine months.

What is the risk associated with M-M-RVAXPRO?

The most common side effects with M-M-RVAXPRO (seen in more than 1 patient in 10) are fever (38.5°C or higher), and injection site redness, pain and swelling. Injection site reactions were less common when the vaccine was injected into a muscle. For the full list of all side effects reported with M-M-RVAXPRO, see the package leaflet.

M-M-RVAXPRO should not be used in people who may be hypersensitive (allergic) to any measles, mumps or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic). M-M-RVAXPRO must not be given during pregnancy, any illness with fever (over 38.5°C) or active untreated tuberculosis (TB). It must also not be given to patients with certain blood or immune diseases. For the full list of restrictions, see the package leaflet.

Why has M-M-RVAXPRO been approved?

The CHMP decided that M-M-RVAXPRO's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe use of M-M-RVAXPRO?

The company that makes M-M-RVAXPRO will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVAXPRO leads to side effects such as allergic reactions.

Other information about M-M-RVAXPRO:

The European Commission granted a marketing authorisation valid throughout the European Union for M-M-RVAXPRO to Sanofi Pasteur MSD SNC on 5 May 2006. The marketing authorisation is valid for an unlimited period.

The full EPAR for M-M-RVAXPRO can be found here. For more information about treatment with M-M-Rvaxpro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011.

M-M-RVAXPRO

EMA/272118/2011

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