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Demonstrated efficacy of the M-M-R®II vaccine

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Subcutaneous administration

Help protect against measles, mumps, and rubella with high immune response rates starting after the first dose

In a clinical trial of 284a patients, M-M-R®II seroconversion rates were high after the first dose.

aClinical studies of 284 triple-seronegative children 11 months to 7 years of age, demonstrated that subcutaneously administered M-M-R®II is highly immunogenic. In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of susceptible individuals.

M-M-R®II immunization provides coverage that can last over 10 years

Based on data from a clinical study, neutralizing and ELISA antibodies to MMR viruses were still found years after primary vaccination.

Antibodies were detected 11–13 years after primary vaccination in:

95%–100%

of individuals against measles

74%–91%

of individuals against mumps

90%–100%

of individuals against rubella

Similar immune responsesa when administered intramuscularly vs subcutaneously1

aSeroresponse rates (SRR): Percentage of children seronegative at baseline who achieved antibody titers > the seroresponse thresholds 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, obtained 6 weeks postvaccination.

Lower bound of the 95% CI of the seroresponse rates was >90% after IM administration for measles, mumps, and rubella.

Study Design:

In an open label clinical trial (NCT00432523), 752 children 12 through 18 months of age received M-M-R®II either intramuscularly (n=374) or subcutaneously (n=378), concomitantly with VARIVAX® (Varicella Virus Vaccine Live). For each vaccine antigen at least 89% of enrolled children were seronegative at baseline.

Noninferiority criteria for IM administration

Pre-specified criteria: Lower bound of the 95% CI for the difference in seroresponse rates (IM group – SC group) was ≥ -10%; noninferiority met for measles, mumps, and rubella.2

Post hoc analysis criteria: Lower bound of the 95% CI for the difference in seroresponse rates (IM group – SC group) was ≥ -5%; noninferiority met for mumps and rubella, narrowly missed for measles (-5.28%).

CI, confidence interval; IM, intramuscular; MMR, measles, mumps, rubella; SC, subcutaneous.

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Dosage and administration

Discover the dosing regimen and administration of M-M-R®II.

Review MMR dosing

ACIP recommendations

Find out about the ACIP recommendations for MMR vaccinations in pediatric patients.3

See the ACIP recommendations

References

  1. U.S Food and Drug Administration (FDA). Statistical Review – Measles, Mumps, and Rubella Virus Vaccine Live. Updated March 8, 2023. Accessed July 24, 2023. https://www.fda.gov/media/166052/download
  2. Gillet Y, Habermehl P, Thomas S, et al. Immunogenicity and safety of concomitant administration of a measles, mumps and rubella vaccine (M-M-RvaxPro®) and a varicella vaccine (VARIVAX®) by intramuscular or subcutaneous routes at separate injection sites: a randomised clinical trial. BMC Med. 2009;7(16). https://doi.org/10.1186/1741-7015-7-16
  3. Centers for Disease Control and Prevention. Recommended child and adolescent immunization schedule for ages 18 years or younger, United States, 2023. Updated November 16, 2023. Accessed November 16, 2023. https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

Indications and Usage for M-M-R®II

  • M-M-R®II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older.
  • The first dose of M-M-R®II is administered at 12 to 15 months of age and the second dose of M-M-R®II is administered at 4 to 6 years of age.

Selected Safety Information for M-M-R®II

  • 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 reaction to neomycin; individuals who are immunodeficient or immunosuppressed due to disease or medical therapy; an active febrile illness; active untreated tuberculosis; or those who are pregnant or are planning to become pregnant within the next month.
  • Due caution should be employed in administration of M-M-R®II to persons with: a history of febrile seizure or family history of febrile seizures; immediate-type hypersensitivity reactions to eggs; thrombocytopenia.
  • Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent.
  • Immune globulins (IG) and other blood products should not be given concurrently with M-M-R®II. The ACIP has specific recommendations for intervals between administration of antibody-containing products and live virus vaccines.
  • The following adverse reactions have been identified during both the subcutaneous and intramuscular use of M-M-R®II or its components in clinical trials or reported during post-approval use: fever, rash, and injection-site reactions.
  • The following adverse reactions have been identified during the subcutaneous use of M-M-R®II or its components in clinical trials or reported during post-approval use: headache, dizziness, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, thrombocytopenia, encephalitis and encephalopathy.

Dosage and Administration

  • FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY.
  • M-M-R®II vaccine can be administered concurrently with other live viral vaccines. If not given concurrently, M-M-R®II vaccine should be given one month before or one month after administration of other live viral vaccines to avoid potential for immune interference.

 

Before administering M-M-R®II, please read the accompanying Prescribing Information. The Patient Information also is available.

 

Indications and Usage for M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)

  • M-M-R®II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older.
  • The first dose of M-M-R®II is administered at 12 to 15 months of age and the second dose of M-M-R®II is administered at 4 to 6 years of age.

M-M-R®II is a vaccine indicated for active immunization for the prevention of measles, mumps

M-M-R®II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age or older. The first dose of M-M-R®II is administered at 12 to 15 months of age and the second dose of M-M-R®II is administered 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 reaction to neomycin; individuals who are immunodeficient or immunosuppressed due to disease or medical therapy; an active febrile illness; active untreated tuberculosis; or those who are pregnant or are planning to become pregnant within the next month.
  • Due caution should be employed in administration of M-M-R®II to persons with: a history of febrile seizure or family history of febrile seizures; immediate-type hypersensitivity reactions to eggs; thrombocytopenia.
  • Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual’s immune status has been evaluated and the individual has been found to be immunocompetent.
  • Immune globulins (IG) and other blood products should not be given concurrently with M-M-R®II. The ACIP has specific recommendations for intervals between administration of antibody-containing products and live virus vaccines.
  • The following adverse reactions have been identified during both the subcutaneous and intramuscular use of M-M-R®II or its components in clinical trials or reported during post-approval use: fever, rash, and injection-site reactions.
  • The following adverse reactions have been identified during the subcutaneous use of M-M-R®II or its components in clinical trials or reported during post-approval use: headache, dizziness, febrile convulsions, anaphylaxis and anaphylactoid reactions, arthritis, thrombocytopenia, encephalitis and encephalopathy.

Dosage and Administration

  • FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY.
  • M-M-R®II vaccine can be administered concurrently with other live viral vaccines. If not given concurrently, M-M-R®II vaccine should be given one month before or one month after administration of other live viral vaccines to avoid potential for immune interference.

 

Before administering M-M-R®II, please read the accompanying Prescribing Information. The Patient Information also is available.

 

M-M-R®II is contraindicated in certain individuals, including those with: a history of

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 reaction to neomycin; individuals who are immunodeficient or immunosuppressed due to disease or medical therapy; an active febrile illness; active untreated tuberculosis; or those