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Drug Details

M-M-R II

• Drug Class Description
  Live attenuated vaccines.
• Generic Name
  Measles, Mumps, Rubella virus
• Presentation
  Powder for injection.
• Description
  -M-R™ II Measles, Mumps and Rubella Vaccine, Live, Attenuated
• Indications
  

  For simultaneous immunisation against measles, mumps and rubella in the following groups:

  Children: Recommended for both primary and booster immunisation of both boys and girls 12 months of age or older.

  Non-Pregnant Adolescent and Adult Females: Immunisation of susceptible non-pregnant adolescent and adult females of childbearing age is indicated when the potential vaccinee agrees not to become pregnant for the next 3 months after vaccination and is informed of the reason, (this also applies to women in the immediate post-partum period when it may be found most convenient to vaccinate) and is told of the frequent occurrence of generally self-limiting arthralgia and/or arthritis beginning 2-4 weeks after vaccination.

  International Travellers: Individuals planning travel abroad who are known to be susceptible to one or more of these diseases can receive either a single antigen vaccine (measles, mumps or rubella), if available, or a combined antigen vaccine as appropriate. A combined measles, mumps and rubella vaccine is preferred for persons likely to be susceptible to mumps and rubella as well as measles.

• Adult Dosage
  

  The vaccine is administered by deep subcutaneous or intramuscular injection preferably into the outer aspect of the arm.

  Children who suffered ITP within six weeks of the first dose of MMR (or its component vaccines), should have serological status evaluated at the time the second dose was due. If serology testing suggests that a child is not fully immune against measles, mumps and rubella then a second dose of MMR is recommended

  Adults and children: After suitably cleansing the injection site, 0.5 millilitre of reconstituted vaccine should be injected. M-M-R™ II must not be given intravenously.

  Do not give immunoglobulin with M-M-R™ II.

  Warning: A sterile syringe and epinephrine (adrenaline) injection should be available for immediate use should an anaphylactic reaction occur.

  Revaccination: A second dose of measles, mumps and rubella vaccine is recommended in the national immunisation schedule.

  Use with other vaccines: Vaccines containing diphtheria, tetanus and pertussis antigens and/or oral poliomyelitis vaccine can be administered at the same time as M-M-R™ II. For concurrent parenteral vaccination, separate syringes and separate sites for injection should be used.

  M-M-R™ II should not be given less than one month before or after immunisation with other live viral vaccines

• Child Dosage
  

  Children receiving their first dose of measles, mumps and rubella vaccine younger than 12 months of age should be revaccinated at 15 months of age. They may still receive a further dose at the time indicated in the national immunisation schedule, (M-M-R™ II is not recommended for infants under 12 months of age.)

• Contra Indications
  

  Do not give M-M-R™ II to pregnant females; the possible effects of the vaccine on foetal development are unknown at this time. Pregnancy must be avoided for three months following vaccination of post-pubertal females.

  Anaphylactic or anaphylactoid reactions to a previous dose of vaccine or to neomycin or any other vaccine constituent including gelatin. (Each dose of reconstituted vaccine contains approximately 25 micrograms neomycin.)

  Any febrile respiratory illness, or other active or suspected infection.

  Those with impaired immune responsiveness, whether occurring naturally or as a result of therapy with steroids, radiotherapy, cytotoxic or other agents. This contra-indication does not apply to patients receiving corticosteroids as replacement therapy, e.g. for Addisons's disease.

  Patients with active untreated tuberculosis, blood dyscrasias such as thrombocytopenia, leukaemia, malignant disease including lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic systems.

  Primary and acquired immunodeficiency states, including patients who are immunosuppressed in association with AIDS or other clinical manifestations with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinaemic and dysgammaglobulinaemic states.Fatal cases of measles inclusion body encephalitis (MIBE) and pneumonitis as a direct consequence of disseminated measles vaccine virus infection have been reported in severely immunocompromised individuals vaccinated with measles-containing vaccine.Those patients with a family history of congenital hereditary immunodeficiency until their immune competence has been demonstrated.

  Children below 12 months of age: Children below 12 months of age should not normally be given M-M-R™ II unless they are at special risk, since the presence of maternal antibody may interfere with their ability to respond. They may be given human normal immunoglobulin. However, where immunisation below the age of 12 months is deemed necessary, a second dose of vaccine should be given at 15 months of age and a further dose may still be given at the usual time.

• Special Precautions
  

  As with all vaccines, facilities for the management of anaphylaxis, including epinephrine (adrenaline), should always be available during vaccination.

  Hypersensitivity to eggs: There is increasing evidence that M-M-R™ II can be given safely to children even if they have previously had an anaphylactic reaction (generalised urticaria, swelling of the mouth and throat, difficulty in breathing, hypotension or shock) following food containing egg. Nevertheless, caution should be observed and if there is concern, paediatric advice should be sought with a view to immunisation under controlled conditions such as admission to hospital as a day case.

  M-M-R™ II should be given with caution to those with an individual or family history of cerebral injury or any other condition in which stress due to fever should be avoided. The physician should be alert to the rise in temperature that may follow vaccination.

  Children and young adults who are known to be infected with, or have a history of immunodeficiency viruses, but without overt clinical manifestations of immunosuppression, may be vaccinated; however, the vaccinees should be closely monitored for exposure to vaccine-preventable diseases because immunisation may be less effective than for uninfected persons. In selected cases, confirmation of circulating antibody levels may be indicated to help guide appropriate protective measures, including immunoprophylaxis if immunity has waned to non-protective levels.

  Children who suffered ITP within 6 weeks of the first dose of MMR (or its component vaccines) should have serological status evaluated at the time the second dose was due. If serology testing suggests that a child is not fully immune against measles, mumps and rubella then a second dose of MMR is recommended.

  Excretion of small amounts of live attenuated rubella virus from the nose and throat has occurred in the majority of susceptible individuals 7-28 days after vaccination. There is no definite evidence to indicate that such a virus is transmitted to susceptible persons who are in contact with vaccinated individuals. Consequently, transmission, while accepted as a theoretical possibility, has not been regarded as a significant risk. However, transmission of the vaccine virus via breast milk has been documented.

  There are no reports of transmission of live attenuated measles or mumps viruses from vaccinees to susceptible contacts.

  Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunised with live measles virus vaccine; no studies have been reported to date of the effect of measles virus vaccines on untreated tuberculous children.

  Parents of children with a personal or family history of convulsions or idiopathic epilepsy should be advised that such children have a small increased risk of seizures following vaccination and be informed in advance of procedures for their management.

  As for any vaccine, vaccination with M-M-R ™II may not result in protection in 100% of vaccinees

• Interactions
  

  Vaccination should be deferred for at least three months following blood or plasma transfusions or administration of any human immune serum globulin. If any of these substances has been used near to the time of vaccination with M-M-R™ II, a test should subsequently be made to confirm successful seroconversions.

  Where anti-Rho (D) globulin (human) and rubella vaccine are required in the immediate post-partum period, rubella vaccine alone and not M-M-R™ II should be used.

  It has been reported that live attenuated measles, mumps and rubella vaccine may temporarily depress tuberculin skin sensitivity. If a tuberculin test is to be done, it should be administered before or simultaneously with M-M-R™ II.

• Adverse Drug Reactions
  

  Adverse reactions associated with the use of M-M-R™ II are those which have been reported following administration of the monovalent or combination vaccines. The data reported from clinical studies or through post marketing surveillance are provided below without regard to causality or frequency.

  Infections and infestations:

  Atypical measles, orchitis, otitis media, parotitis, rhinitis, subacute sclerosing panencephalitis (SSPE - see below), aseptic meningitis

  Cases of aseptic meningitis have been reported following measles, mumps and rubella vaccination. Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis

  Blood and the lymphatic system disorders:

  Regional lymphadenopathy, thrombocytopenia

  Immune System disorders:

  Anaphylaxis and anaphylactoid reactions, as well as related phenomena such as angioneurotic oedema (including peripheral or facial oedema)

  Psychiatric disorders:

  Irritability

  Nervous system disorders:

  Febrile convulsions in children, afebrile convulsion or seizures, headache, dizziness, paraesthesia, polyneuritis, polyneuropathy, Guillain-Barré syndrome, ataxia, measles inclusion body encephalitis (MIBE), encephalitis (see below), encephalopathy (see below), optic neuritis, retrobulbar neuritis, ocular palsies, syncope

  Encephalitis/encephalopathy have been reported approximately once for every 3 million doses. In no case has it been shown that reactions were actually caused by vaccine. The risk of such serious neurological disorders following live measles virus vaccine administered remains far less than that for encephalitis and encephalopathy with wild-type measles (1 per 2000 reported cases).

  There have been reports of (SSPE) in children who did not have a history of infection with wild-type measles but did receive measles vaccine. Some of these cases may have resulted from unrecognised measles in the first year of life or possibly from the measles vaccination. Based on the estimated nationwide measles vaccine distribution in the USA, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed. This is far less than the association with wild-type measles: 6-22 cases of SSPE per million cases of measles.

  A study suggests that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.

  Eye disorders:

  Retinitis, conjunctivitis

  Ear and labyrinth disorders:

  Nerve deafness

  Vascular disorders

  Vasculitis

  Respiratory, thoracic and mediastinal disorders:

  Bronchial spasm, cough, pneumonitis, sore throat

  Gastrointestinal disorders:

  Nausea, vomiting, diarrhoea

  Skin and subcutaneous tissue disorders:

  Panniculitis, purpura, skin induration, Stevens-Johnson syndrome, erythema multiforme, pruritis, urticaria

  Musculoskeletal, connective tissue and bone disorders:

  Arthralgia and/or arthritis (usually transient and rarely chronic [see below]), myalgia.

  Arthralgia or arthritis, or both, are usually transient and rarely chronic features of wild-type rubella. Like polyneuritis that is also a feature of wild-type infection, their frequency and severity vary with age and sex, being greatest in adult females and least in prepubertal children.

  The chronic arthritis associated with wild-type rubella has been related to virus and/or viral antigen found in body tissues. Only rarely have vaccinees developed chronic joint symptoms.

  Following vaccination in children, reactions in joints are uncommon and generally of brief duration. In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (children; 0-3%; women: 12-20%) and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or, on rare occasions, for years. In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women. Even in older women (35-45 years) these reactions are generally well tolerated and rarely interfere with normal activities. Such reactions occur much less frequently after revaccination than primary vaccination.

  General disorders and administration site conditions:

  Burning and/or stinging at the injection site for a short period, rash or measles-like rash (usually minimal but may be generalised), fever (38.3°C (101°F) or higher).

  Generally fever or rash or both appear between the 5th and 12th days.

  Malaise, papillitis, peripheral oedema, swelling, tenderness, vesiculation at injection site, wheal and flare at injection site, erythema at injection site.

  Local reactions characterised by marked swelling, redness and vesiculation at the injection site of attenuated live measles virus vaccines and systemic reactions including atypical measles have occurred in vaccines who had previously received killed measles vaccine. Rarely, there have been reports of more severe reactions, including prolonged high fevers and extensive local reactions requiring hospitalisation.