Evaluation of the Safety and Immunogenicity of M-M-RII (Combination Measles-mumps-rubella Vaccine)

Abstract

Background:The safety and immunogenicity of M-M-RII (measles, mumps and rubella virus vaccine live, Merck & Co., Inc., West Point, PA)the only combined measles, mumps and rubella vaccine licensed for use in the United States-were previously reported in pre-and postlicensure clinical trials conducted from 1988 to 2009. M-M-RII continues to be evaluated as a comparator in clinical trials of other vaccines. Here, we review safety and efficacy data from more recent clinical trials of M-M-RII. Methods: We performed a systematic literature review of trials using M-M-RII published from 2010 to 2019. Results: In the 15 studies that met the inclusion criteria, a total of 12,032 subjects were vaccinated: 7667 persons received a first dose only, 2137 participated in 2-dose studies (128 received 1 dose and 2009 received both) and 2063 received a single dose of M-M-RII as their second dose. Dose number was not specified for 165 participants, ≥6 years old, in 2 studies in which a single dose of M-M-RII was administered. Similar to previous reports, M-M-RII was well tolerated and immunogenic when administered alone or concomitantly with other routinely recommended vaccinations. The most common adverse events included transient injection site pain and fever. Serious adverse events were extremely rare, with only 4 probable or potential vaccine-related events reported among the 12,032 participating subjects. Conclusions: In trials published from 2010 to 2019, M-M-RII continued to be safe and immunogenic in all age groups studied. These data, along with the results of earlier trials, indicate that the performance of the vaccine has been consistent across more than 30 years of postlicensure studies.

Safety of measles, mumps, and rubella vaccine in adolescents and adults in the vaccine safety Datalink

“…This suggests that serious outcomes observed in the risk window are unlikely to be associated with MMR receipt; however, among all serious outcomes identified, one case of anaphylaxis was attributed to vaccination in the medical record. Although CIs were wide for several serious outcomes, including meningitis and anaphylaxis, these findings are reassuring and consistent with smaller studies of MMR safety in adolescents and young adults [10] , [13] , as well as studies in young children [3] , [26] .…”

“…Comparison of results of non-serious outcomes among adolescents and adults to those experienced by younger children is challenging. Most data on safety of MMR in children are derived from clinical trials and other studies in which adverse events were prospectively solicited and did not require seeking medical attention [3] , [5] . It is therefore difficult to conclude whether or not non-serious outcomes after MMR, namely local and systemic reactogenicity, are less common in adolescents and adults than children.…”

“…Previous studies have found that MMR-containing vaccines are generally well tolerated [3] , [4] , [5] ; however, these studies have primarily been conducted among young children. Data on the safety of MMR administered to adolescents or adults are mainly from vaccination campaigns during outbreaks [6] , [7] , [8] , [9] , [10] and an assessment of events reported to the U.S.…”