Indications

M-M-R®II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

The ACIP recommends administration of the first dose of M-M-R®II at 12 to 15 months of age and administration of the second dose of M-M-R®II at 4 to 6 years of age.

Selected Safety Information for M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)

M-M-R®II is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactic or anaphylactoid reaction to neomycin; blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary or acquired immunodeficiency conditions; family history of congenital or hereditary immunodeficiency or receiving immunosuppressive therapy; an active febrile illness; or those who are pregnant. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination.

Due caution should be employed in administration of M-M-R®II to persons with: a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; thrombocytopenia.

The following adverse reactions have been reported with M-M-R®II without regard to causality: fever, headache, dizziness, rash, injection-site reactions, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, and thrombocytopenia. Additional adverse reactions, which have been reported without regard to causality, include encephalitis and encephalopathy in their diverse clinical presentations.

Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).

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

Dosage and Administration

FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravascularly.

Immune globulin (IG) is not to be given concurrently with M-M-R®II.

M-M-R®II should be given one month before or after administration of other live viral vaccines. M-M-R®II has been administered concurrently with VARIVAX® (Varicella Virus Vaccine Live) and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes.

Before administering M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), please read the Prescribing Information. The Patient Information also is available.

1. Centers for Disease Control and Prevention (CDC). Vaccine Storage & Handling Toolkit. http://www.cdc.gov/vaccines/hcp/admin/storage/
toolkit/storage-handling-toolkit.pdf. Published June 2016. Accessed March 24, 2017.
2. Centers for Disease Control and Prevention (CDC). Milestones in the history of vaccination. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th rev ed. Washington, DC: Public Health Foundation; 2015:ii–xi.
3. Food and Drug Administration (FDA). Center for
Biologics Evaluation and Research (CBER). CBER clinical review of studies submitted in support of licensure of ProQuad™. http://www.fda.gov/downloads/
biologicsbloodvaccines/vaccines/
approvedproducts/ucm123800.pdf. Effective August 26, 2005. Accessed March 24, 2017.
4. Centers for Disease Control and Prevention (CDC). Recommended immunization schedule for children and adolescents aged 18 years or younger, United States, 2017. https://www.cdc.gov/vaccines/schedules/downloads/
child/0-18yrs-child-combined-schedule.pdf. Effective January 1, 2017. Accessed March 24, 2017.

Dosage and Administration

FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravascularly.

Immune globulin (IG) is not to be given concurrently with M-M-R®II.

M-M-R®II should be given one month before or after administration of other live viral vaccines. M-M-R®II has been administered concurrently with VARIVAX® (Varicella Virus Vaccine Live) and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes.

Dosage

  • The dose for any age is 0.5 mL administered subcutaneously, preferably into the outer aspect of the upper arm.
  • The recommended age for primary vaccination is 12 to 15 months.
  • Children first vaccinated when younger than 12 months of age should receive another dose between 12 to 15 months of age followed by revaccination prior to elementary school entry.
  • Immune globulin (IG) is not to be given concurrently with M-M-R®II.

Administration

  • A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection and/or reconstitution of the vaccine because these substances may inactivate the live virus vaccine. A 25-gauge, 5/8" needle is recommended.
  • To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine.
Image of Vial to injected

Single Dose Vial

  • Withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilized vaccine, and agitate to mix thoroughly. If the lyophilized vaccine cannot be dissolved, discard. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine subcutaneously.
  • It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B and other infectious agents from one person to another.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. M-M-R®II, when reconstituted, is clear yellow.

Use With Other Vaccines

  • M-M-R®II should be given one month before or after administration of other live viral vaccines.
  • M-M-R®II has been administered concurrently with VARIVAX® (Varicella Virus Vaccine Live), and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes.
  • Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.
  • The ACIP has stated “Although data are limited concerning the simultaneous administration of the entire recommended vaccine series (i.e., DTaP [or DTwP], IPV [or OPV], Hib with or without Hepatitis B vaccine, and varicella vaccine), data from numerous studies have indicated no interference between routinely recommended childhood vaccines (either live, attenuated, or killed). These findings support the simultaneous use of all vaccines as recommended.”

ACIP=Advisory Committee on Immunization Practices; Hib=Haemophilus influenzae type b.

Indications

M-M-R®II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.

The ACIP recommends administration of the first dose of M-M-R®II at 12 to 15 months of age and administration of the second dose of M-M-R®II at 4 to 6 years of age.

Selected Safety Information for M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)

M-M-R®II is contraindicated in certain individuals, including those with: a history of hypersensitivity to any component of the vaccine, including gelatin; a history of anaphylactic or anaphylactoid reaction to neomycin; blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; primary or acquired immunodeficiency conditions; family history of congenital or hereditary immunodeficiency or receiving immunosuppressive therapy; an active febrile illness; or those who are pregnant. If vaccination of postpubertal females is undertaken, pregnancy should be avoided for 3 months following vaccination.

Due caution should be employed in administration of M-M-R®II to persons with: a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided; anaphylaxis or immediate hypersensitivity to eggs; thrombocytopenia.

The following adverse reactions have been reported with M-M-R®II without regard to causality: fever, headache, dizziness, rash, injection-site reactions, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, and thrombocytopenia. Additional adverse reactions, which have been reported without regard to causality, include encephalitis and encephalopathy in their diverse clinical presentations.

Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).

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

Dosage and Administration

FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravascularly.

Immune globulin (IG) is not to be given concurrently with M-M-R®II.

M-M-R®II should be given one month before or after administration of other live viral vaccines. M-M-R®II has been administered concurrently with VARIVAX® (Varicella Virus Vaccine Live) and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes.

Before administering M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live), please read the Prescribing Information. The Patient Information also is available.

VACC-1159574-0004 09/17