"European Union (EU) regulators have recommended market approval of a combination bacterial and viral vaccine (Vaxelis, Sanofi Pasteur) that immunizes children against six different disorders.
The new injectable vaccine is indic"...
Recommended Vaccination Schedule
Individuals first vaccinated at 12 months of age or older should be revaccinated prior to elementary school entry. Revaccination is intended to seroconvert those who do not respond to the first dose. The Advisory Committee on Immunization Practices (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.59 In addition, some public health jurisdictions mandate the age for revaccination. Consult the complete text of applicable guidelines regarding routine revaccination including that of high-risk adult populations.
Measles Outbreak Schedule
Infants Between 6 to 12 Months of Age
Local health authorities may recommend measles vaccination of infants between 6 to 12 months of age in outbreak situations. This population may fail to respond to the components of the vaccine. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established. The younger the infant, the lower the likelihood of seroconversion (see CLINICAL PHARMACOLOGY). Such infants should receive a second dose of M-M-R II between 12 to 15 months of age followed by revaccination at elementary school entry.59
Unnecessary doses of a vaccine are best avoided by ensuring that written documentation of vaccination is preserved and a copy given to each vaccinee's parent or guardian.
Other Vaccination Considerations
Non-Pregnant Adolescent and Adult Females
Immunization of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see below and PRECAUTIONS). Vaccinating susceptible postpubertal females confers individual protection against subsequently acquiring rubella infection during pregnancy, which in turn prevents infection of the fetus and consequent congenital rubella injury.33
Women of childbearing age should be advised not to become pregnant for 3 months after vaccination and should be informed of the reasons for this precaution.
The ACIP has stated “If it is practical and if reliable laboratory services are available, women of childbearing age who are potential candidates for vaccination can have serologic tests to determine susceptibility to rubella. However, with the exception of premarital and prenatal screening, routinely performing serologic tests for all women of childbearing age to determine susceptibility (so that vaccine is given only to proven susceptible women) can be effective but is expensive. Also, 2 visits to the health-care provider would be necessary — one for screening and one for vaccination. Accordingly, rubella vaccination of a woman who is not known to be pregnant and has no history of vaccination is justifiable without serologic testing — and may be preferable, particularly when costs of serology are high and follow-up of identified susceptible women for vaccination is not assured.”33
Previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women should receive live attenuated rubella vaccine (such as that contained in monovalent rubella vaccine or in M-M-R II) to reduce the risk of exposure of the pregnant woman.
Individuals planning travel outside the United States, if not immune, can acquire measles, mumps, or rubella and import these diseases into the United States. Therefore, prior to international travel, individuals known to be susceptible to one or more of these diseases can either receive the indicated monovalent vaccine (measles, mumps, or rubella), or a combination vaccine as appropriate. However, M-M-R II is preferred for persons likely to be susceptible to mumps and rubella; and if monovalent measles vaccine is not readily available, travelers should receive M-M-R II regardless of their immune status to mumps or rubella.34-36
Vaccination is recommended for susceptible individuals in high-risk groups such as college students, health-care workers, and military personnel.33,34,37
According to ACIP recommendations, most persons born in 1956 or earlier are likely to have been infected with measles naturally and generally need not be considered susceptible. All children, adolescents, and adults born after 1956 are considered susceptible and should be vaccinated, if there are no contraindications. This includes persons who may be immune to measles but who lack adequate documentation of immunity such as: (1) physician-diagnosed measles, (2) laboratory evidence of measles immunity, or (3) adequate immunization with live measles vaccine on or after the first birthday.34
The ACIP recommends that “Persons vaccinated with inactivated vaccine followed within 3 months by live vaccine should be revaccinated with two doses of live vaccine. Revaccination is particularly important when the risk of exposure to wild-type measles virus is increased, as may occur during international travel.”34
Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours of exposure. If, however, vaccine is given a few days before exposure, substantial protection may be afforded.34,38,39 There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.33,37
Use With Other Vaccines
See DOSAGE AND ADMINISTRATION, Use With Other Vaccines.
DOSAGE AND ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION
Do not inject intravascularly.
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.
Revaccination with M-M-R II is recommended prior to elementary school entry. See also INDICATIONS AND USAGE, Recommended Vaccination Schedule.
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.59 See also INDICATIONS AND USAGE, Measles Outbreak Schedule.
CAUTION: 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.
Single Dose Vial — First 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 (Oka/Merck)], and PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] using separate injection sites and syringes. No impairment of immune response to individually tested vaccine antigens was demonstrated. The type, frequency, and severity of adverse experiences observed with M-M-R II were similar to those seen when each vaccine was given alone.
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.
However, other schedules have been used. 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.”32
No. 4681 - M-M-R II is supplied as follows: (1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00; and (2) a box of 10 vials of diluent (package B). To conserve refrigerator space, the diluent may be stored separately at room temperature.
To maintain potency, M-M-R II must be stored between -58°F and +46°F (-50°C to +8°C). Use of dry ice may subject M-M-R II to temperatures colder than -58°F (-50°C).
Protect the vaccine from light at all times, since such exposure may inactivate the viruses.
Before reconstitution, store the lyophilized vaccine at 36°F to 46°F (2°C to 8°C). The diluent may be stored in the refrigerator with the lyophilized vaccine or separately at room temperature. Do not freeze the diluent.
It is recommended that the vaccine be used as soon as possible after reconstitution. Store reconstituted vaccine in the vaccine vial in a dark place at 36°F to 46°F (2°C to 8°C) and discard if not used within 8 hours.
For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.
32. Centers for Disease Control and Prevention. Recommended childhood immunization schedule — United States, January-June 1996, MMWR 44(51 & 52): 940-943, January 5, 1996.
33. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MMWR 39(RR-15): 1-18, November 23, 1990.
34. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22, December 29, 1989.
35. Jong, E.C., The Travel and Tropical Medicine Manual, W.B. Saunders Company, p. 12-16, 1987.
36. Committee on Immunization Council of Medical Societies, American College of Physicians, Phila., PA, Guide for Adult Immunization, First Edition, 1985.
37. Recommendations of the Immunization Practices Advisory Committee (ACIP), Mumps Prevention, MMWR 38(22): 388-400, June 9, 1989.
38. King, G.E.; Markowitz, L.E.; Patriarca, P.A.; et al: Clinical Efficacy of Measles Vaccine During the 1990 Measles Epidemic, Pediatr. Infect. Dis. J. 10(12): 883-888, December 1991.
39. Krasinski, K.; Borkowsky, W.: Measles and Measles Immunity in Children Infected With Human Immunodeficiency Virus, JAMA 261(17): 2512-2516, 1989.
59. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR 47(RR-8): May 22, 1998.
Dist. by: Merck Shar & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: 02/2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/11/2014
Additional M-M-R II Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.