M-M-R II

What it is

M-M-R II is a sterile lyophilised preparation containing a more attenuated line of measles virus derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell cultures; the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell cultures; and the Wistar RA 27/3 strain of live attenuated rubella virus propagated in human diploid cell (WI-38) culture. The reconstituted vaccine is for subcutaneous or intramuscular administration. When reconstituted, each dose contains not less than the equivalent of 1000 TCID50 (50% tissue culture infectious doses) of Measles Virus; 12,500 TCID50 of Mumps Virus; and 1000 TCID50 of Rubella Virus.

Approved indications

— Simultaneous immunisation against measles, mumps and rubella.

Dosing overview

The dosage of vaccine is the same for all persons. The total volume of the single dose vial (approximately 0.5 mL) is injected intramuscularly or subcutaneously, preferably into the outer aspect of the upper arm. Refer to the NHMRC Australian Immunisation Handbook for vaccination recommendations and schedule.

Key safety warnings

Adequate treatment provisions including adrenaline (epinephrine) should be available for immediate use should an anaphylactic or anaphylactoid reaction occur. Patients should be observed for a sufficient period (at least 20 minutes) for the occurrence of early onset reactions seen with measles vaccine. Due caution should be employed in administration of M-M-R II to persons with individual or family histories of convulsions, cerebral injury or any other condition in which stress due to fever should be avoided. The physician should be alert to the temperature elevation which may occur following vaccination. Live measles vaccine and live mumps vaccine are produced in chick embryo cell culture. Persons with a history of anaphylactic or anaphylactoid or other immediate reactions subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of chick embryo antigen and should not be vaccinated with M-M-R II. This vaccine should be given subcutaneously to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following intramuscular administration. Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia with the first dose of M-M-R II may develop thrombocytopenia with repeat doses.

Contraindications

Hypersensitivity to any component of the vaccine, including gelatin. M-M-R II should not be given to pregnant females. Anaphylactic or anaphylactoid reaction to neomycin (each dose of reconstituted vaccine contains approximately 25 µg of neomycin). History of anaphylactic or anaphylactoid reaction to eggs, any febrile respiratory illness or other active febrile infection, active untreated tuberculosis, and patients receiving immunosuppressive therapy. Individuals with blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems, and primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinaemic and dysgammaglobulinaemic states. Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.

Regulatory history

M-M-R II was first listed on the Australian Register of Therapeutic Goods on 14 February 2006. Three variants are registered: powder for injection vial single dose (ARTG 118451), powder for injection vial with diluent vial single dose (ARTG 118449), and powder for injection vial with pre-filled diluent syringe single dose (ARTG 201877, first listed 12 December 2012).