Vaccine Information: M-M-R II (Page 3 of 4)

15 REFERENCES

  1. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR 43(RR-1): 1-38, January 28, 1994.
  2. 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.
  3. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gelatin, J. Allergy Clin. Immunol. 91: 867-872, 1993.
  4. Bitnum, A.; et al: Measles Inclusion Body Encephalitis Caused by the Vaccine Strain of Measles Virus. Clin. Infect. Dis. 29: 855-861, 1999.
  5. Angel, J.B.; et al: Vaccine Associated Measles Pneumonitis in an Adult with AIDS. Annals of Internal Medicine, 129: 104-106, 1998.
  6. Cecinati V, et al. Vaccine administration and the development of immune thrombocytopenic purpura in children. Human Vaccines & Immunotherapeutics 9:5, 2013.
  7. Mantadakis E, Farmaki E, Buchanan GR. Thrombocytopenic Purpura after Measles-Mumps-Rubella Vaccination: A Systematic Review of the Literature and Guidance for Management. J Ped 156(4): 2010.
  8. Andrews N, Stowe J, Miller E, Svanstrom H, Johansen K, Bonhoeffer J, et al. A collaborative approach to investigating the risk of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark. Vaccine. 2012;30:3042-6.
  9. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MMWR 39(RR-15): 1-18, November 23, 1990.
  10. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatrics, 344-357, 1997.
  11. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22, December 29, 1989.
  12. Eberhart-Phillips, J.E.; et al: Measles in pregnancy: a descriptive study of 58 cases. Obstetrics and Gynecology, 82(5): 797-801, November 1993.
  13. Jespersen, C.S.; et al: Measles as a cause of fetal defects: A retrospective study of ten measles epidemics in Greenland. Acta Paediatr Scand. 66: 367-372, May 1977.
  14. Yamauchi T, Wilson C, Geme JW Jr. Transmission of live, attenuated mumps virus to the human placenta. N Engl J Med. 1974;290(13):710-712.
  15. Rubella Vaccination during Pregnancy —United States, 1971-1988. JAMA. 1989;261(23):3374–3383.
  16. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666, 1982.
  17. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. I. Development and characterization of specific immunologic reactivity in breast milk, J. Infect. Dis. 145: 654-660, 1982.
  18. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 97: 465-467, 1980.
  19. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)
  20. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Studies of immunization with living rubella virus: Trials in children with a strain cultured from an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965.
  21. Plotkin, S.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fibroblasts: Evidence for reduced nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.
  22. Weibel, R.E.; Carlson, A.J.; Villarejos, V.M.; Buynak, E.B.; McLean, A.A.; Hilleman, M.R.: Clinical and Laboratory Studies of Combined Live Measles, Mumps, and Rubella Vaccines Using the RA 27/3 Rubella Virus, Proc. Soc. Exp. Biol. Med. 165: 323-326, 1980.
  23. Watson, J.C.; Pearson, J.S.; Erdman, D.D.; et al: An Evaluation of Measles Revaccination Among School-Entry Age Children, 31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstract #268, 143, 1991.
  24. Unpublished data from the files of Research Laboratories of Merck Sharp & Dohme LLC, Rahway, NJ, USA.
  25. Davidkin, I.; Jokinen, S.; Broman, M. et al.: Persistence of Measles, Mumps, and Rubella Antibodies in an MMR-Vaccinated Cohort: A 20-Year Follow-up, JID 197:950–6, April 2008.
  26. LeBaron, W.; Beeler J.; Sullivan, B.; et al.: Persistence of Measles Antibodies After 2 Doses of Measles Vaccine in a Postelimination Environment, Arch Pediatr Adolesc Med. 161:294-301, March 2007.
  27. LeBaron, C.; Forghani, B.; Beck, C. et al.: Persistence of Mumps Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine, JID 199:552– 60 , February 2009.
  28. LeBaron, W.; Forghani, B.; Matter, L. et al.: Persistence of Rubella Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine, JID 200:888–99, September 2009.
  29. Hilleman, M.R.; Buynak, E.B.; Weibel, R.E.; et al: Development and Evaluation of the Moraten Measles Virus Vaccine, JAMA 206(3): 587-590, 1968.
  30. Weibel, R.E.; Stokes, J.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 3. Clinical and Serologic Aspects in a Field Evaluation, N. Engl. J. Med. 276: 245-251, 1967.
  31. Hilleman, M.R.; Weibel, R.E.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 4. Protective Efficacy as Measured in a Field Evaluation, N. Engl. J. Med. 276: 252-258, 1967.
  32. Cutts, F.T.; Henderson, R.H.; Clements, C.J.; et al: Principles of measles control, Bull WHO 69(1): 1-7, 1991.
  33. Weibel, R.E.; Buynak, E.B.; Stokes, J.; et al: Evaluation Of Live Attenuated Mumps Virus Vaccine, Strain Jeryl Lynn, First International Conference on Vaccines Against Viral and Rickettsial Diseases of Man, World Health Organization, No. 147, May 1967.
  34. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; et al: Vaccination With RA 27/3 Rubella Vaccine, Am. J. Dis. Child. 123: 133-136, February 1972.
  35. Rosen, L.: Hemagglutination and Hemagglutination-Inhibition with Measles Virus, Virology 13: 139-141, January 1961.
  36. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363, 1970.
  37. Buynak, E.B.; et al: Live Attenuated Mumps Virus Vaccine 1. Vaccine Development, Proceedings of the Society for Experimental Biology and Medicine, 123: 768-775, 1966.
  38. Hilleman M.R., Studies of Live Attenuated Measles Virus Vaccine in Man: II. Appraisal of Efficacy. Amer. J. of Public Health, 52(2):44-56, 1962.
  39. Johnson, C.E.; et al: Measles Vaccine Immunogenicity in 6- Versus 15-Month-Old Infants Born to Mothers in the Measles Vaccine Era, Pediatrics, 93(6): 939-943, 1994.

16 HOW SUPPLIED/STORAGE AND HANDLING

M-M-R II vaccine is supplied as follows:
(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00
(2) a box of 10 prefilled syringes of sterile diluent, NDC 0006-4175-88 (package B) OR a box of 10 vials of sterile diluent, NDC 0006-4309-00 (package B)

Storage

Vaccine Vial

Exposure to light may inactivate the vaccine viruses.

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).

Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F (2°C to 8°C).

Sterile Diluent

The sterile diluent should be stored in the refrigerator (36°F to 46°F, 2°C to 8°C) or at room temperature (68°F to 77°F, 20°C to 25°C). Do not freeze the sterile diluent.

Administer M-M-R II vaccine immediately after reconstitution. If not administered immediately, reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.

For information regarding the product or questions regarding storage conditions, call 1-800-637-2590.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Package Insert).

Discuss the following with the patient:

  • Provide the required vaccine information to the patient, parent, or guardian.
  • Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
  • Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine or other measles-, mumps-, or rubella-containing vaccines.
  • Question females of reproductive potential regarding the possibility of pregnancy. Inform female patients to avoid pregnancy for 1 month following vaccination [see Contraindications (4.5) and Use in Specific Populations (8.1)].
  • Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100% protection from measles, mumps, and rubella infection.
  • Instruct patients, parents, or guardians to report any adverse reactions to their health-care provider. The U.S. Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at https://www.vaers.hhs.gov .

Distributed by: Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA

For patent information: www.msd.com/research/patent

Copyright © 1978-2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights reserved.

uspi-v205c-i-2308r014

Patient InformationM-M-R® II (pronounced “em em ar too”)Measles, Mumps, and Rubella Virus Vaccine Live

This is a summary of information about M-M-R® II. You should read it before you or your child receives the vaccine. If you have any questions about the vaccine after reading this leaflet, you should ask your health care provider. This is a summary only. It does not take the place of talking about M-M-R II with your doctor, nurse, or other health care provider. Only your health care provider can decide if M-M-R II is right for you or your child.

What is M-M-R II and how does it work?

M-M-R II is also known as Measles, Mumps, and Rubella Virus Vaccine Live. It is a live virus vaccine that is given as a shot. This vaccine is usually given to people one year old or older. It is meant to help prevent measles (rubeola), mumps, and rubella (German measles).

M-M-R II contains weakened forms of measles virus, mumps virus, and rubella virus.

M-M-R II works by helping the immune system protect you or your child from getting measles, mumps, or rubella.

M-M-R II may not protect everyone who gets the vaccine. M-M-R II does not treat measles, mumps, or rubella once you or your child has them.

What do I need to know about measles, mumps, and rubella?

Measles is also known as rubeola. It is a serious illness. Measles virus can be passed to others if you have it. Measles can give you a high fever, cough, and a rash. The illness can last for 1 to 2 weeks. In rare cases, it can also cause an infection of the brain. This could lead to seizures, hearing loss, intellectual disability, and even death.

Mumps can also be passed to others. This virus can cause fever and headache. It can also make the glands under your jaw swell and be painful. The illness often lasts for several days. Sometimes, mumps can make the testicles swell and be painful. In some cases, it can cause meningitis, which is a swelling of the coverings of the brain and spinal cord.

Rubella is also known as German measles. It is often a mild illness. Rubella virus can cause a mild fever, swollen glands in the neck, pain and swelling in the joints, and a rash that lasts for a short time. It can be very dangerous if a pregnant woman catches it. Women who catch German measles when they are pregnant can have babies who are stillborn. Also, the babies may be blind or deaf, or have heart disease or intellectual disability.

Who should not get M-M-R II?

Do not get M-M-R II if you or your child:

  • are allergic to any of its ingredients. (This includes gelatin. See the ingredient list at the end of this leaflet.)
  • have a weakened immune system (which includes taking high doses of steroids by mouth or in a shot).
  • have a fever.
  • have active tuberculosis that is not treated.
  • are pregnant or plan to get pregnant within the next month.

What should you tell your health care provider before getting M-M-R II?

Tell your health care provider if you or your child:

  • have or have had any medical problems.
  • have a history of seizures or someone in your family has a history of seizures.
  • have received blood or plasma transfusions or human serum globulin.
  • take any medicines. (This includes non-prescription medicines and dietary supplements.)
  • have any allergies.
  • had an allergic reaction to any other vaccine.
  • have or have had a low blood platelet count.
  • are allergic to eggs.

How is M-M-R II given?

M-M-R II is given as a shot to people one year old or older. The dose of the vaccine is the same for everyone. If your child gets the shot when he or she is one year old or older, a second dose is recommended. Often, the second dose is given right before the child goes to elementary school (4 to 6 years of age), but may be given earlier as long as the second dose is at least one month after the first dose.

If your child is less than one year old when he or she first gets the shot, a second dose should be given when they are 12 to 15 months old. Then, a third shot should be given between 4 and 6 years of age. Your doctor will decide the best time and number of shots by using official recommendations.

If a dose is missed, your health care provider will let you know when you should have it.

What are the possible side effects of M-M-R II?

The most common side effect of vaccination with M-M-R II is pain at the site of the shot for a short time.

Other side effects may include:

  • Fever
  • Rash

Less common side effects may also include:

  • Swelling of the testicles
  • Joint pain and/or swelling

Some side effects are rare but may be serious. You should call your health care provider if you notice any of the following problems:

  • Difficulty breathing, wheezing, hives, or a skin rash may be signs of an allergic reaction
  • Bleeding or bruising under the skin
  • Seizures, a severe headache, a change in behavior or consciousness, or difficulty walking

Other side effects may also occur. Your doctor has a more complete list of side effects for M-M-R II.

Contact your doctor or health care provider if you or your child have any new or unusual symptoms after receiving M-M-R II.

Report the following to your doctor or your child’s doctor:

  • exposure to M-M-R II during pregnancy
  • exposure to M-M-R II during the month before getting pregnant

You may also report any adverse reactions to your doctor or your child’s health care provider or submit a report directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or you may report online to www.vaers.hhs.gov.

What are the ingredients of M-M-R II?

Active Ingredients: weakened forms of the measles, mumps, and rubella viruses.

Inactive Ingredients: sorbitol, sucrose, hydrolyzed gelatin, recombinant human albumin, fetal bovine serum, other buffer and media ingredients, neomycin.

What else should I know about M-M-R II?

This leaflet summarizes important information about M-M-R II.

If you would like more information, talk to your health care provider or call 1-800-622-4477.

Dist. by: Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA

For patent information: www.msd.com/research/patent

Copyright © 1978-2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates.
All rights reserved.

usppi-v205c-i-2303r206

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2023

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