Characteristics of the medicine
ProQuad is a measles, mumps, rubella and chickenpox vaccine. ProQuad is a suspension that can be administered subcutaneously (ie by an injection under the skin). The active ingredients are the attenuated (weakened) viruses that cause individual diseases.
Therapeutic indications
ProQuad is given to babies over 12 months to help protect them from the four diseases: measles, mumps, rubella and chickenpox. The drug can only be obtained by prescription.
How to use
ProQuad is available in the form of two components: a powder that must be kept frozen and a solvent contained in a bottle or pre-filled syringe, which is stored in the refrigerator or at room temperature. Immediately before administration, the doctor or nurse will prepare the suspension for injection by dissolving the frozen powder with the solvent.
Two doses of the weakened chickenpox virus are needed to protect against chickenpox; Two doses of ProQuad can be given for this purpose or a single dose followed by a dose of another vaccine that only protects against chickenpox. The second dose in both cases is given 1-3 months after the first dose.
Mechanisms of action
ProQuad is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defenses) to defend itself against a disease. ProQuad contains attenuated forms of the viruses that cause measles, mumps, rubella and chickenpox. When the vaccine is given, the The immune system recognizes attenuated 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 the viruses again. The antibodies will help protect the body from disease. caused by these viruses.
Studies carried out
ProQuad contains well known attenuated viruses already used in other vaccines. When ProQuad was studied in humans, it was compared with the "component vaccines", ie, a triple measles, mumps and rubella vaccine and a varicella vaccine. The vaccine was studied in 5446 children. healthy (12-23 months) who received a dose of ProQuad. The studies performed measured the vaccine's "immunogenicity" (i.e. its ability to make the immune system respond to viruses). One study also looked at responses to viruses. year after vaccination in 2 108 children.
Benefits found following the studies
Response rates (which measure how the immune system responded to viruses) were 97.4% for measles, 95.8% for mumps, 98.5% for rubella and 91. , 2% for chickenpox. After the second dose, response rates were 99.4% for measles, 99.9% for mumps, 98.3% for rubella, and 99.4% for chickenpox, respectively.
Associated Risks
The most common side effect observed in the studies performed was fever (in more than one in 10 children). For a complete list of all side effects reported with ProQuad, please refer to the product package insert. Children should not be vaccinated with Proquad if they have an allergy to any type of vaccine against chickenpox, measles, mumps and rubella, to any of the ingredients they contain, to neomycin, or if they have immune disorders.
For a complete list of all restrictions, see the product package insert.
Reasons for approval
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of ProQuad outweigh the risks it poses in concurrent vaccination against measles, mumps, rubella and chickenpox of children over 12 months old. The Committee recommended the "marketing authorization" of ProQuad, recommending the administration of a second dose of varicella vaccine to complete protection from the disease.
Further information
On April 6, 2006, the European Commission granted Sanofi Pasteur MSD SNC a "marketing authorization" for ProQuad, valid throughout the European Union.
The full version of the EPAR for ProQuad is available by clicking here.
Last updated: 04-2006
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