Use of M-M-R II outside of the routinely recommended age range – a systematic literature review

ABSTRACT

M-M-R®_II (M-M-R II) is routinely used in many countries at 12–15 months with a second dose at 4 to 6 years of age. However, the vaccine may need to be administered at other ages due to delays in the immunization schedule or in certain situations such as outbreaks or international travel. A systematic literature review was conducted to evaluate efficacy, immunogenicity and safety of M-M-R II among 6- to 11-month-olds and persons ≥7 years of age. A search for randomized controlled trials (RCTs) was conducted in 2019 including Medline, Embase and Cochrane CENTRAL. Only one study reported seroconversion rates after one dose in infants at 9 months of age: 87.4% (measles), 92.3% (mumps), and 91.2% (rubella); no safety data were reported. Seven studies reported immunogenicity and safety data for M-M-R II at ≥7 years of age. Seroconversion rates ranged from 96%-100% (measles), 65%-100% (mumps), and 91%-100% (rubella). Rates of selected adverse events ranged from 5.2%-8.7% for fever (≥38°C or ≥38.1°C), 2%-33.3% for injection site reactions, and 0.4% for measles/rubella-like rash (one study). No efficacy studies were found. This literature review identified RCTs with evidence to support that M-M-R II is immunogenic and well tolerated in individuals ≥7 years of age.

KEYWORDS:

• MMR vaccine
• measles
• mumps
• rubella
• efficacy
• immunogenicity
• safety
• age
• infants

Disclosure of potential conflicts of interest

MP, ER, LPS, are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA and stockholders of Merck & Co., Inc., Kenilworth, NJ, USA. ES, MN, LK are employees of Certara, Loerrach, Germany, and were consultants for Merck & Co., Inc., Kenilworth, NJ, USA and paid for their services. SL and BK are former employees of Merck & Co., Inc., GM is an investigator on Merck clinical trials and GM, JF are consultants for Merck & Co., Inc., Kenilworth, NJ, USA.

Notes

1. Grey literature is literature that is not formally published in sources such as books or journal article.²³ It is defined as “Information produced on all levels of government, academics, business and industry in electronic and print formats not controlled by commercial publishing i.e. where publishing is not the primary activity of the producing body”^24–26.

Additional information

Funding

This work was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA