Indications for: M-M-R II
Measles, mumps and rubella immunization.
Clinical studies included 284 seronegative children aged 11 months to 7 years who were found to be immunogenic following administration of M-M-R II vaccine. These studies showed 95%, 96%, and 99% antibody responses to measles H1, mumps, and rubella HI, respectively, among susceptible individuals.
Clinical Study of Infants 6 to 15 Month of Age
Infants 6 through 15 months of age born to mothers vaccinated with a measles vaccine in childhood were evaluated in a clinical study.
74% of the 6 month old infants achieved detectable neutralizing antibody titers following infant and toddler vaccination subcutaneously with Measles Virus Vaccine, Live.
100% of the 15 month old infants achieved detectable neutralizing antibody titers following vaccination with Measles Virus Vaccine, Live or M-M-II vaccine.
Revaccination of the 6 month old infants of immunized mothers with M-M-R II vaccine achieved antibody titers similar to that of the 15 month old infants
Open Label Clinical Trial in Children 12 Through 18 Months of Age
The clinical trial (NCT00432523) included 752 children 12 through 18 months of age who received M-M-R II either intramuscularly (n=374) or subcutaneously (n=378), concomitantly with Varivax. Antibody responses to measles, mumps, and rubella viruses were measured by ELISAs using sera obtained 6 weeks post-vaccination.
For anti-measles virus, anti-mumps virus and anti-rubella virus, seroresponse rates were defined as the percentage of children seronegative at baseline who achieved antibody titers above the respective seroresponse threshold for each assay 6 weeks post vaccination. Seroresponse thresholds were defined as 255 mIU/mL, 10 EU/mL, and 10 IU/mL for anti-measles virus, anti-mumps virus, and anti-rubella virus antibodies, respectively.
In a post hoc analysis, mumps and rubella viruses for the intramuscular group achieved noninferiority to the subcutaneous group for seroresponse rates (the lower bound of the 95% confidence interval for the difference in seroresponse rates [intramuscular group minus subcutaneous group] ≥-5%). The seroresponse rate to the measles virus did not achieve noninferiority but it narrowly missed meeting the post hoc criterion of -5%.
After intramuscular administration, >90% seroresponse rates were achieved for measles, mumps, and rubella antigens. The point estimates of the proportions of children achieving antibody titers above the seroresponse thresholds for measles, mumps, and rubella viruses were as follows: 94.3%, 97.7%, and 98.1%, respectively, in the intramuscular group and 96.1%, 98.1%, and 98.1%, respectively, in the subcutaneous group.
Adults and Children:
<12 months: not established. Each dose is 0.5mL. Give by SC or IM inj. First dose at 12–15 months of age, second dose at 4–6yrs of age (ACIP recommendations). Postexposure prophylaxis: give dose within 72hrs after exposure.
M-M-R II Contraindications:
Gelatin or neomycin hypersensitivity. Active febrile illness with fever >101.3°F (>38.5°C). Active untreated tuberculosis. Immunosuppression. Pregnancy.
M-M-R II Warnings/Precautions:
Have epinephrine inj available. Previous or history of febrile seizures. Hypersensitivity to eggs. Thrombocytopenia or history of, after immunization with a previous dose of MMR vaccine. Defer vaccination if history of immunodeficiency until immunocompetent. Nursing mothers.
M-M-R II Classification:
M-M-R II Interactions:
Avoid concomitant immunosuppressants, including high dose corticosteroids. Concomitant immune globulins, other blood products: may interfere with the immune response. May interfere with tuberculin test; if necessary, administer the test before, simultaneously with, or at least 4–6wks after vaccination. May be administered with other live viral vaccines; if not given concurrently, give M-M-R II vaccine 1 month before or after other live viral vaccines.
Fever, rash, malaise, sore throat, headache, local reactions, arthritic symptoms, parotitis, orchitis, thrombocytopenia, purpura; encephalitis (rare).
Generic Drug Availability:
Single dose vial—10 (w. diluent)