M-M-R II VACCINE

General Administration Information
For storage information, see the specific product information within the How Supplied section.
-Inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the parent or guardian before each immunization. This action is required by the National Childhood Vaccine Injury Act of 1986.
-Record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine in the patient's permanent record. These actions are required by the National Childhood Vaccine Injury Act of 1986.

Route-Specific Administration

Injectable Administration
-Administer only via the subcutaneous (MMR II, Priorix) or intramuscular (MMR II) route; do not inject intravenously or intradermally.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The reconstituted MMR II vaccine should be clear yellow; the reconstituted Priorix vaccine should be a clear peach-to fuchsia pink-colored suspension.
-Due to the potential for errors, establish a process to keep vaccines and their corresponding prefilled diluent syringe together if storage requirements do not differ. Prepare only 1 vaccine at a time and relabel the diluent syringe with the vaccine name after reconstitution.
Intramuscular Administration
Reconstitution (MMR II)
-Use only the sterile vaccine diluent supplied with this vaccine, which may be in the form of a vial or a prefilled syringe. This diluent is free from preservatives or other agents that might inactivate the vaccine. Aseptic technique must be observed because the products do not contain preservatives.
-If using the supplied vial of diluent, withdraw the entire volume of the supplied diluent from the diluent vial and inject into the vial containing the lyophilized vaccine. If using the supplied prefilled syringe, attach a needle to the prefilled syringe and inject the entire volume of diluent from the syringe slowly into the vaccine vial. Gently agitate to mix thoroughly. Discard the vaccine if it cannot be dissolved.
-Storage: Immediate use of the reconstituted vaccine is recommended, but the product may be stored at 2 to 8 degrees C (36 to 46 degrees F) if protected from light and used within 8 hours. Discard unused portions.

Intramuscular Injection (MMR II)

-Withdraw the entire volume of the reconstituted vaccine and inject intramuscularly.

Subcutaneous Administration
Reconstitution (MMR II)
-Use only the sterile vaccine diluent supplied with this vaccine, which may be in the form of a vial or a prefilled syringe. This diluent is free from preservatives or other agents that might inactivate the vaccine. Aseptic technique must be observed because the products do not contain preservatives.
-If using the supplied vial of diluent, withdraw the entire volume of the supplied diluent from the diluent vial and inject into the vial containing the lyophilized vaccine. If using the supplied prefilled syringe, attach a needle to the prefilled syringe and inject the entire volume of diluent from the syringe slowly into the vaccine vial. Gently agitate to mix thoroughly. Discard the vaccine if it cannot be dissolved.
-Storage: Immediate use of the reconstituted vaccine is recommended, but the product may be stored at 2 to 8 degrees C (36 to 46 degrees F) if protected from light and used within 8 hours. Discard unused portions.

Reconstitution (Priorix)

-Use only the prefilled syringe of Sterile Water diluent component supplied with this vaccine.
-While holding the prefilled syringe by the barrel, unscrew the syringe cap by twisting it counterclockwise. Align the needle to the axis of the syringe and attach by gently connecting the needle hub into the Luer Lock Adaptor (LLA); rotate a quarter turn clockwise until you feel it lock.
-After cleansing the vial stopper, transfer the entire contents of the prefilled syringe into the lyophilized antigen component vial. Shake well until the powder is completely dissolved; do not invert the vial while shaking.
-Storage: Immediate use of the reconstituted vaccine is recommended, but the product may be stored at 2 to 8 degrees C (36 to 46 degrees F) if used within 8 hours. Discard unused portions.

Subcutaneous Injection

-Withdraw the entire volume of the reconstituted vaccine and inject subcutaneously.

Adverse neurological events are rare after administration of MMR vaccine. Although several cases of sensorineural deafness have been reported, a causal relationship to MMR vaccine has not been established. Rumors that MMR vaccine may be causally related to increased cases of autism in children have caused substantial parental concern about MMR vaccination. Previous studies have found no relationship between autism and MMR administration. In 2001, two important studies were released which concluded that vaccination with MMR is not associated with an increased risk of autism.

Measles vaccination substantially reduces the occurrence of subacute sclerosing panencephalitis (SSPE). Although SSPE has occurred in recipients of the MMR vaccine who had no history of natural measles infection, evidence indicates that at least some of these children had unrecognized measles infection before vaccination and that the SSPE was directly related to the natural measles infection. Thus, administration of live measles vaccine does not increase the risk for SSPE, even among persons who have previously had measles disease or received live measles vaccine.

Events reported after administration of measles/mumps/rubella vaccines, MMR or its component vaccines without regard to causality include retinitis, papillitis, retrobulbar neuritis, polyneuritis, polyneuropathy, syncope, and paresthesias. Expert committees at the Institute of Medicine (IOM) have reviewed available evidence concerning the causal relationship between MMR vaccination and various adverse events. Although vasculitis, otitis media, conjunctivitis, optic neuritis, ocular palsies, Guillain-Barre syndrome, and ataxia have been reported after administration of MMR or its component vaccines and are listed in the manufacturer's package insert, the IOM has determined that no causal relationship has been established between these events and MMR vaccination. In addition, evidence does not support a causal association of measles-containing vaccine with risk for Crohn's disease or other inflammatory bowel disease. Although cases of Guillain-Barre syndrome (GBS) have been reported after administration of MMR vaccination, a causal relationship has not been established. Mass vaccination campaigns that involved approximately 8 million doses of measles-rubella vaccine in the UK and more than 70 million doses of measles vaccine in Latin America demonstrated no increased incidence of GBS over baseline rates. Transverse myelitis has also been reported after MMR vaccination, but causality is unknown. Cases of aseptic meningitis have been reported to VAERS after measles, mumps, and rubella vaccination. Although a causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn mumps vaccine to aseptic meningitis.

Febrile and afebrile seizures have been reported with MMR vaccination. Approximately 5% of children develop a fever of >= 103 degrees F after measles virus, mumps virus, rubella virus (MMR) vaccination. Febrile reactions usually occur 7-12 days after vaccination and generally last 1-2 days. Most persons with fever are otherwise asymptomatic; however, febrile seizures have been reported occasionally. The risk of seizure attributable to the measles component of MMR is approximately 1 in 3000 doses and usually occurs 6-11 days after vaccination. A higher incidence of seizures has been reported in patients 15-35 days after administration of MMR containing the Urabe mumps strain (1 in 2600 Urabe doses). The measles virus, mumps virus, rubella virus, varicella virus (MMRV) vaccine is associated with a 2-fold increased risk of febrile seizures compared to separately administered MMR and varicella vaccines. Delaying the administration of measles-containing vaccines may increase the risk of seizures after immunization. In a retrospective cohort study (n = 840,348), the risk of seizures 7-10 days after vaccination with a measles-containing vaccine was greater in patients who received the vaccine at ages 16-23 months compared to those who received it between 12 and 15 months of age (relative risk, 6.5; 95% CI, 5.3-8.1). Data from a population-based cohort study of 537,171 children of whom 82% received MMR vaccination at 15-17 months of age suggest that prematurity, male gender, low birth weight, or a family history of febrile seizures do not significantly affect the likelihood of febrile seizures after MMR vaccination. Children with febrile seizures after MMR vaccinations did not have an increased rate of epilepsy development as compared with children who were unvaccinated at the time of their first febrile seizure. Due to the limited number of children with a sibling with epilepsy, more data are needed to determine if these children are more likely to have a febrile seizure after MMR vaccination as compared with nonvaccinated children. The Advisory Committee on Immunization Practices recommends vaccination of children with a personal or family history of convulsions, as the benefits substantially outweigh the risks.

Allergic reactions, including pruritus have been temporally associated with mumps vaccination but are usually mild and of brief duration. Measles- and rubella-containing vaccines (including MMR) can cause transient rashes (e.g., maculopapular rash). The rash usually appears 7 to 10 days after vaccination and occurs in roughly 5% of vaccinated persons. Transient lymphadenopathy and parotitis have also been reported rarely following administration of MMR or other mumps-containing vaccine. Other hypersensitivity reactions, usually consisting of urticaria or a wheal and flare at the injection site (i.e., injection site reaction), occur rarely after administration of MMR. Immediate anaphylactic reactions are very rare. The reported rate of possible anaphylactic shock after vaccination with measles-containing vaccine is less than 1 case per 1 million doses (CDC, unpublished data). Angioedema, bronchospasm, Stevens-Johnson syndrome, Henoch-Schonlein purpura, acute hemorrhagic edema of infancy, and erythema multiforme have been reported during clinical trials with MMR or with monovalent or bivalent vaccine containing measles, mumps, or rubella.

Surveillance of adverse reactions in the U.S. and other countries indicates that measles virus, mumps virus, rubella virus (MMR) vaccine can, in rare instances, cause clinically important thrombocytopenia within 2 months after vaccination. In prospective studies, the reported frequency of clinically apparent thrombocytopenia after MMR vaccination was 1 case per 30,000-40,000 vaccinated, with a temporal clustering of cases occurring 2-3 weeks after vaccination. Based on passive surveillance, the reported frequency of thrombocytopenia is roughly 1 case per 100,000 doses in Canada and France, and 1 case per 1 million doses in the United States. The clinical course of these cases was usually transient and benign, although hemorrhage occurred rarely. In children, a causal association of MMR vaccine and idiopathic thrombocytopenic purpura (ITP) has been demonstrated. The absolute risk of ITP in children aged 12-23 months within 6 weeks of immunization was 1 in 22,300 doses (two of every three cases of ITP were vaccine-attributed). The MMR-related cases tended to be milder and of shorter-duration than non-vaccine associated cases. Children with ITP before MMR vaccine had no vaccine-associated recurrences of purpura; the authors concluded that a history of previous ITP did not contraindicate the administration of the vaccine.

Encephalitis, acute disseminated encephalomyelitis (ADEM), encephalopathy, and measles inclusion body encephalitis have been reported without regard to causality during clinical trials of the measles/mumps/rubella vaccine, MMR or with use of monovalent or bivalent vaccine containing measles, mumps, or rubella. There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of infection with wild-type measles but did receive the measles vaccine. The association of SSPE cases to measles vaccination is about 1 case per million vaccine doses distributed, which is much less than the association with wild-type measles infection (6 to 22 cases of SSPE per million cases of measles). Encephalitis and encephalopathy have been reported approximately once for every 3 million doses of MMR vaccine administered since licensure of these vaccines. Roughly 1 in 1,000 persons infected with measles virus develops encephalitis with resultant permanent central nervous system impairment. Thus, encephalopathy occurs much less frequently after administration of measles vaccine than after measles infection. Measles inclusion body encephalitis, pneumonitis, and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised patients inadvertently vaccinated with measles-containing vaccine.

Joint symptoms are associated with the rubella component of measles virus, mumps virus, rubella virus (MMR) vaccine. Among susceptible persons, arthralgia and transient arthritis occur more frequently among adults than among children and more frequently among postpubertal females than among males. Acute arthralgia or arthritis are rare among children who receive RA 27/3 vaccine. By contrast, arthralgia develops in roughly 25% of susceptible postpubertal females after RA 27/3 vaccination and approximately 10% have acute arthritis-like signs and symptoms. When acute joint symptoms do occur, they generally begin 1-3 weeks after vaccination, persist for 1 day to 3 weeks, and rarely recur. Myalgia also has been associated with the use of MMR vaccine.

Gastrointestinal adverse reactions may occur with the administration of measles virus, mumps virus, and rubella virus vaccine. Nausea, vomiting, diarrhea, parotitis, and pancreatitis were reported either during clinical trials, post-marketing use, or with the use of monovalent or bivalent vaccine containing measles, mumps, or rubella.

Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in most susceptible patients 7 to 28 days after vaccination. No documented confirmed cases of transmitted rubella vaccine virus have been reported.

Prior to administration, inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine, and provide the Vaccine Information Statement, accessible at the Centers for Disease Control and Prevention (CDC) website. These actions are required by the National Childhood Vaccine Injury Act of 1986. If a dose of measles virus; mumps virus; rubella virus vaccine has been previously given, question the parent or guardian about previous adverse reactions that may preclude further administration. Report all adverse reactions to the Vaccine Adverse Event Reporting System (VAERS), as well as the manufacturer. The toll-free number for VAERS is 1-800-822-7967. Educate the responsible adult(s) to promptly report any adverse reaction after vaccine administration to a health care provider.

Do not give the measles, mumps, and rubella (MMR) vaccine via intravenous administration. The vaccine is for subcutaneous (MMR II, Priorix) or intramuscular (MMR II) administration only.

The measles, mumps, and rubella (MMR) vaccine is contraindicated in patients with hypersensitivity to any vaccine component. MMR II is contraindicated in patients with a gelatin hypersensitivity; it contains hydrolyzed gelatin as a stabilizer. Use the Priorix vaccine with caution in patients with a latex hypersensitivity; the tip caps of the prefilled syringes of diluent contain natural rubber latex. Because measles and mumps viruses are cultured from chick embryos, and each vaccine dose contains 25 mcg or less of neomycin, it is generally regarded that patients with a history of egg hypersensitivity or neomycin hypersensitivity are more likely to develop an allergic reaction if given the MMR vaccine. The MMR vaccine is contraindicated in persons who have experienced an anaphylactic reaction to topically or systemically administered neomycin. However, a history of contact dermatitis to neomycin is not a contraindication to receiving MMR vaccination; in these patients, the adverse reaction to neomycin in the vaccine is usually an erythematous, pruritic nodule or papule appearing 48 to 96 hours after vaccination. In persons allergic to eggs, the risk for serious allergic reactions after administration of measles- or mumps-containing vaccines is extremely low, but patients with a history of anaphylactic, anaphylactoid, or other immediate reactions after egg ingestion may be at an enhanced risk of an immediate-type hypersensitivity reaction. In a study of 54 children with documented egg allergy, a single 0.5 mL subcutaneous dose of the MMR vaccine was administered safely, despite the confirmation of egg allergy with a food challenge. Thus, according to the CDC, skin testing is not required before administering MMR to persons allergic to eggs. As with any biologic product, the prescriber or healthcare professional should have procedures in place to manage allergic reactions. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy.

Thrombocytopenia and immune thrombocytopenic purpura (ITP) have been reported after vaccination with measles, mumps, and rubella (MMR) vaccine. Transient thrombocytopenia has been reported within 4 to 6 weeks of vaccination with MMR II. Consider the potential risks and benefits of vaccination in patients with thrombocytopenia or in those who experienced thrombocytopenia after previous vaccination with the MMR vaccine. In children, a causal association of MMR vaccine and ITP has been demonstrated. In 1 study, the absolute risk of ITP in children aged 12 to 23 months within 6 weeks of immunization was 1 in 22,300 doses (2 of every 3 cases of ITP were vaccine-attributed). The MMR-related cases tended to be milder and of shorter-duration than non-vaccine associated cases. Children with ITP before MMR vaccine had no vaccine-associated recurrences of purpura; the authors concluded that a history of previous ITP did not contraindicate the administration of the vaccine. The decision to vaccinate children with MMR should depend on the benefits of immunity to measles, mumps, and rubella and the risks for recurrence or exacerbation of thrombocytopenia after vaccination or during natural infection with measles or rubella. The benefits of primary immunization are usually greater than the potential risks, especially when the incidence of thrombocytopenia after measles or rubella disease is considered.

Children with a history of cerebral injury or a personal or family history of a seizure disorder may be at an increased risk of developing febrile seizures after MMR vaccination. The risk of this complication, however, appears to be low. In addition, febrile seizures occur commonly among children in whom measles disease develops. Therefore, according to the CDC, the benefits of administering MMR vaccine to children with a history of convulsions substantially outweighs the risks.

The MMR vaccine is only indicated in patients at least 12 months of age, but receipt in infants may be acceptable in certain conditions between 6-12 months of age. The vaccine may not be as immunogenic in infants. If vaccination first occurred before the age of 12 months, revaccinate between 12 and 15 months of age and again before elementary school entry. Use of the MMR vaccine is not recommended in neonates.

Recommendations and precautions for patients with immunosuppression are complex, but the measles virus; mumps virus; rubella virus (MMR) live vaccine is contraindicated in any person with a primary immunodeficiency state (e.g., severe combined immunodeficiency (SCID), IgA deficiency, hypogammaglobulinemia, agammaglobulinemia, or dysgammaglobulinemia) or an acquired immunodeficiency state. Measles inclusion body encephalitis, pneumonitis, and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised patients inadvertently vaccinated with measles-containing vaccine; additionally, disseminated mumps and rubella virus infection has occurred in immunosuppressed patients who were inadvertently given the MMR vaccine. A family history of congenital or hereditary immunodeficiency is also a contraindication for MMR vaccine unless the immune competence of the potential vaccine recipient is demonstrated. The MMR vaccine may be administered to persons with human immunodeficiency virus (HIV) infection if the CD4 count is 200 cells/mm3 or higher (CD4 percentage of 15% or higher); however, patients with a CD4 count less than 200 cell/mm3 (CD4 percentage less than 15%) or who meet the diagnostic criteria of acquired immunodeficiency syndrome (AIDS) should not receive the vaccine. The MMR vaccine should also not be administered to those with cellular immune deficiency or those patients on immunosuppressive therapy such as high-dose corticosteroid therapy. However, corticosteroid therapy is usually not a contraindication to administering live-virus vaccines when administration is short-term (less than 2 weeks); a low-to-moderate dose (less than 2 mg/kg of body weight or 20 mg/day of prednisone or equivalent for persons who weigh more than 10 kg when administered for less than 2 weeks); long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or when administered topically (skin, eyes), inhaled, or by local injection. Healthcare providers should wait at least 1 month after discontinuation of high-dose corticosteroid therapy given for more than 2 weeks before administering MMR vaccine. The vaccine is also contraindicated in patients with blood dyscrasias or any neoplastic disease that causes bone marrow suppression or affects the lymphatic system such as leukemia or lymphoma, including patients currently receiving chemotherapy or radiation therapy. Patients with leukemia, lymphoma, or other malignancies whose disease is in remission and whose chemotherapy or radiation therapy has been terminated for at least 3 months can receive live-virus vaccines.

The measles virus, mumps virus, rubella virus (MMR) vaccine is classified by the FDA as pregnancy risk category C and is contraindicated in pregnancy. Females of reproductive capacity should educated on the importance of prevention of pregnancy for 3 months after vaccination. No adequate and well-controlled studies have been undertaken, and it is not known if the vaccine can cause fetal harm or affect reproduction capacity. If inadvertent vaccination of a pregnant adolescent occurs, inform her of the possible risks associated with the vaccine. Patients and health care providers are also encouraged to report any exposure to the Merck Sharp & Dohme Corporation pregnancy registry by calling 1-800-986-8999. Acquisition of wild-type measles during pregnancy has reportedly lead to increased rates of spontaneous abortion, stillbirth, congenital defects, and prematurity; while there are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy it would be prudent to assume that the vaccine strain is also capable of inducing adverse fetal effects. Mumps vaccine virus has been shown to infect the placenta and fetus, although there is no evidence that it causes congenital malformations in humans. Administration of rubella vaccine within 3 months before or after conception did not result in abnormalities compatible with congenital rubella syndrome in a 10-year survey involving over 700 pregnant women (of whom 189 received the Wistar RA 27/3 strain).

The measles virus, mumps virus, rubella virus (MMR) vaccine is contraindicated in patients with a febrile respiratory illness or other active febrile infection. The decision to administer or to delay vaccination because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices recommends that vaccinations be delayed during the course of a moderate or severe acute febrile illness and administered after the acute phase of illness has resolved. All vaccines can be given to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Patients with active, untreated tuberculosis should not be vaccinated with MMR. The effect of measles virus vaccines on children with untreated tuberculosis is unknown. Exacerbation of tuberculosis after live measles virus vaccination in children who are being treated for tuberculosis has not been noted.

The measles, mumps, and rubella (MMR) vaccine may result in temporary suppression of tuberculin reactivity causing a laboratory test interference with a tuberculin skin test. Therefore, administer a tuberculin skin test either before, simultaneously with, or at least 4 to 6 weeks after MMR vaccination to avoid false-negative results. Additionally, syndromic polymerase chain reaction (PCR) panels may incorrectly identify a measles infection if a patient recently received an MMR vaccine. Approximately 5% of patients experience a rash after the MMR vaccine; approximately 1% of syndromic panels report a positive measles result after MMR vaccination. Patients identified with a positive result were pediatric patients without known measles risk who, in most cases, received the vaccine less than 3 weeks beforehand. Inclusion of measles virus in syndromic PCR panels can result in incidental detection of measles vaccines. Health care providers should assess clinical features and vaccine history after a positive test.

Description: The measles, mumps, and rubella (MMR) vaccine is a combination injection consisting of 3 live virus vaccinations intended to confer immunity against measles, mumps, and rubella. In addition to children, adolescents and adults should also be up to date on their MMR vaccine. The MMR vaccine is effective at protecting patients against measles, mumps, and rubella, and preventing the complications caused by these diseases. One dose of MMR vaccine is 93% effective against measles, 78% effective against mumps, and 97% effective against rubella. Two doses of MMR vaccine are 97% effective against measles and 88% effective against rubella. About 3 out of 100 patients who get 2 doses of MMR vaccine will get measles if exposed to the virus, however, they are more likely to have a milder illness and are less likely to spread the disease to other people. Although 2 doses of MMR vaccine are 88% effective at preventing mumps, outbreaks can still occur in highly vaccinated U.S. communities, particularly in settings where people have close, prolonged contact, such as universities and close-knit communities. During an outbreak, an additional MMR dose may help improve protection against mumps disease and related complications. The Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory to increase awareness of an increase in measles cases globally and in the United States. From January 1 to March 14, 2024, the CDC was notified of 58 confirmed cases in the United States. Fifty-four (93%) of cases were linked to international travel. Most cases reported in 2024 have been among children aged 12 months and older who have not received measles-mumps-rubella (MMR) vaccine. Vaccination is recommended in patients 6 months and older before international travel and all children 12 months and older who do not plan to travel internationally. MMR vaccine is FDA-approved for use in children as young as 12 months. Ideally, administer at 12 to 15 months and again at 4 to 6 years.

General Dosing Information
-The Centers for Disease Control and Prevention (CDC) has issued a Health Alert Network (HAN) Health Advisory to alert clinicians and public health officials of an increase in measles cases globally and in the United States. Vaccination is recommended in patients 6 months and older before international travel and all children 12 months and older who do not plan to travel internationally.
-The Advisory Committee on Immunization Practices (ACIP) recommends administration of measles, mumps, and rubella (MMR) vaccine and varicella vaccine as separate vaccines for the first dose in children 12 to 47 months of age unless the parent or caregiver expresses a preference for the combination MMRV vaccine. When the MMRV combination vaccine is administered as the first dose to children younger than 48 months, the risk of fever and febrile seizures is higher compared to administration of MMR and varicella vaccines at different injection sites.
-The combination MMRV vaccine is generally preferred for the 2nd dose in patients of any age (15 months through 12 years) and for the first dose in children 48 months or older; however, considerations for using the 2 separate vaccines include provider assessment, patient/parent preference, and potential adverse effects.

For measles prophylaxis, mumps prophylaxis, and rubella prophylaxis:
Subcutaneous dosage (Priorix):
Infants 6 to 11 months*: Although safety and efficacy have not been established, the Centers for Disease Control and Prevention (CDC) recommends administering 0.5 mL subcutaneously to infants who plan to travel or live internationally or during measles outbreaks. Revaccinate with 0.5 mL subcutaneously at age 12 to 15 months (12 months for children in high-risk areas) and dose 2 as early as 28 days later.
Children and Adolescents: 0.5 mL subcutaneously. A 2-dose vaccine schedule during childhood is recommended; administer the first dose at age 12 to 15 months and the second dose at age 4 to 6 years. It may be administered as the second dose in patients who received a first dose of another MMR vaccine. For catch-up immunization, administer the 2 doses at least 28 days apart. A third MMR dose is recommended in patients who were previously vaccinated with 2 doses of a mumps virus-containing vaccine and are identified by public health authorities as being at increased risk for acquiring mumps because of an outbreak. For international travel in patients without evidence of immunity (no documented administration of two doses of measles virus vaccine or no laboratory (serologic) proof of immunity), administer the 2 doses of the MMR vaccine prior to departure; separate doses by at least 28 days. The 2-dose vaccination series is also recommended for HIV-infected pediatric patients who do not have evidence of immunity unless they are severely immunosuppressed (CD4 percentage less than 15% [all ages] or CD4 count less than 200 lymphocytes/mm3 [ages 5 years and older]). Pediatric patients with perinatal HIV infection who received the MMR vaccine prior to beginning effective antiretroviral therapy (ART) and do not have evidence of immunity, should be vaccinated with 2 appropriately spaced doses once effective ART is established.
Intramuscular or Subcutaneous dosage (MMR II):
Infants 6 to 11 months*: Although safety and efficacy have not been established, the Centers for Disease Control and Prevention (CDC) recommends administering 0.5 mL IM or subcutaneously to infants who plan to travel or live internationally or during measles outbreaks. Revaccinate with 0.5 mL IM or subcutaneously at age 12 to 15 months (12 months for children in high-risk areas) and dose 2 as early as 28 days later.
Children and Adolescents: 0.5 mL IM or subcutaneously. A 2-dose vaccine schedule during childhood is recommended; administer the first dose at age 12 to 15 months and the second dose at age 4 to 6 years. For catch-up immunization, administer the 2 doses at least 28 days apart. A third MMR dose is recommended in patients who were previously vaccinated with 2 doses of a mumps virus-containing vaccine and are identified by public health authorities as being at increased risk for acquiring mumps because of an outbreak. For international travel in patients without evidence of immunity (no documented administration of two doses of measles virus vaccine or no laboratory (serologic) proof of immunity), administer the 2 doses of the MMR vaccine prior to departure; separate doses by at least 28 days. The 2-dose vaccination series is also recommended for HIV-infected pediatric patients who do not have evidence of immunity unless they are severely immunosuppressed (CD4 percentage less than 15% [all ages] or CD4 count less than 200 lymphocytes/mm3 [ages 5 years and older]). Pediatric patients with perinatal HIV infection who received the MMR vaccine prior to beginning effective antiretroviral therapy (ART) and do not have evidence of immunity, should be vaccinated with 2 appropriately spaced doses once effective ART is established.
-for post-exposure measles prophylaxis*:
Subcutaneous dosage (Priorix):
Infants 6 to 11 months: 0.5 mL subcutaneously within 72 hours of measles exposure. Infants who receive the vaccination prior to 12 months of age may not achieve immunity to all 3 diseases; therefore, revaccination with 2 MMR doses (first dose at 12 to 15 months, second dose at least 28 days later) is recommended.
Children and Adolescents: 0.5 mL subcutaneously within 72 hours of measles exposure. The vaccine may provide some protection against infection or modify the clinical course of the disease. Additionally, in patients who have received only 1 dose of vaccine prior to measles exposure, revaccination with 0.5 ml subcutaneously within 72 hours of exposure may prevent disease.
Intramuscular or Subcutaneous dosage (MMR II):
Infants 6 to 11 months: 0.5 mL IM or subcutaneously within 72 hours of measles exposure. Infants who receive the vaccination prior to 12 months of age may not achieve immunity to all 3 diseases; therefore, revaccination with 2 MMR doses (first dose at 12 to 15 months, second dose at least 28 days later) is recommended.
Children and Adolescents: 0.5 mL IM or subcutaneously within 72 hours of measles exposure. The vaccine may provide some protection against infection or modify the clinical course of the disease. Additionally, in patients who have received only 1 dose of vaccine prior to measles exposure, revaccination with 0.5 mL IM or subcutaneously within 72 hours of exposure may prevent disease.

Maximum Dosage Limits:
-Neonates
Safety and efficacy have not been established.
-Infants
1 to 5 months: Safety and efficacy have not been established
6 to 11 months: Safety and efficacy have not been established; however, 0.5 mL IM (MMR II) or subcutaneously (MMR II, Priorix) is recommended in certain situations.
-Children
0.5 mL/dose IM (MMR II) or subcutaneously (MMR II, Priorix).
-Adolescents
0.5 mL/dose IM (MMR II) or subcutaneously (MMR II, Priorix).

Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

*non-FDA-approved indication

Monograph content under development

Mechanism of Action: Many epidemiological studies suggest that people who develop disease-specific antibodies to the measles, mumps, and rubella viruses (MMR) following immunization develop long-term immunity in most people. Active immunization with the MMR vaccine stimulates the immune system to produce disease-specific antibodies by inducing a subclinical and noncommunicable infection with attenuated virus particles. Clinical studies indicate that MMR is highly immunogenic, with one injection stimulating measles antibodies (hemagglutination inhibition) in 95% of recipients; mumps-neutralizing antibodies in 96% of recipients; and rubella antibodies (hemagglutination inhibition) in 99% of vaccinees. A small percentage (1-5%) of individuals fail to seroconvert after the primary dose; therefore, 2 doses are necessary. These vaccine-induced antibodies are capable of virus neutralization by opsonization, complement activation, and induction of cell-mediated immunity.

Pharmacokinetics: The measles, mumps, and rubella vaccine (MMR) is administered intramuscularly (MMR II) or subcutaneously (MMR II, Priorix).


-Special Populations
Pediatrics
Infants and Children 11 months to 7 years
Among 284 triple seronegative infants and children aged 11 months to 7 years who received MMR vaccination, measles antibodies were detected in 95%, mumps antibodies in 96%, and rubella antibodies in 99% of susceptible persons.

Long-term immunity
After subcutaneous administration of MMR vaccine, antibodies to measles, mumps, and rubella viruses are still detectable in most individuals 11 to 13 years after primary vaccination. Further data indicate greater than 99% of people receiving 2 doses of measles vaccine (with the first dose administered no earlier than the first birthday) develop serologic evidence of measles immunity. Although vaccination produces lower antibody concentration than natural disease, serologic and epidemiologic evidence indicate vaccination produces long-term, probably life-long immunity in most people. More than 97% of patients develop measurable antibodies after mumps vaccination. Similar to measles, mumps vaccination produces lower antibody concentrations than natural disease, but serologic and epidemiologic data indicate long-term immunity. After vaccination with rubella vaccine, 95% or more of children 12 months or older develop serologic evidence of immunity. Clinical efficacy and challenge studies indicate greater than 90% of people have protection against rubella for at least 15 years.