Priorix, M-M-R II exhibited similar safety, immune response during MMR vaccination
NEW ORLEANS – A measles, mumps and rubella vaccine developed by GlaxoSmithKline to have immune response rates and a safety profile similar to the Merck vaccine, according to phase 3 clinical trial data presented at IDWeek 2016.
“Measles, mumps and rubella (MMR) are highly infectious diseases and their complications are responsible for considerable morbidity and mortality in children throughout the world,” Nicola P. Klein, MD, PhD, a research scientist at the Kaiser Permanente Northern California division of research, said in an interview. “The current MMR vaccine available in the United States is made by Merck & Co. Inc. and was licensed in 1979. Currently, GlaxoSmithKline (GSK) Vaccines is developing an MMR vaccine for U.S. licensure.”
Klein and colleagues conducted a phase 3, multinational, observer-blind clinical trial to determine the consistency of the GSK’s MMR vaccine (Priorix), immunogenic non-inferiority of three pooled lots of the Priorix vaccine compared with Merck’s MMR vaccine (M-M-R II), and reactogenicity and immune response rate of Priorix.
The investigators enrolled 5,003 healthy children aged 12 to 15 months and randomly selected them to receive GSK’s MMR lot 1 (n = 1,239), GSK’s MMR lot 2 (n = 1,232) and GSK’s MMR lot 3 (n = 1,243) or Merck’s MMR (n = 1,289). They assessed fever between 5 and 12 days after immunization, symptoms at 4 days and general injection site at 43 days after immunization.
Data analysis showed that all GSK’s MMR lots met expectations for consistency and immunogenicity and were not inferior compared with Merck’s MMR at 42 days post-vaccination.
“We found that all success criteria for GSK’s investigational MMR vaccine lot-to-lot consistency were met; immune responses to GSK’s MMR vaccine were non-inferior to Merck’s MMR vaccine,” Klein told Infectious Diseases in Children. “GSK’s MMR vaccine demonstrated an acceptable immune response against measles, mumps and rubella; and no safety concerns were identified (reactogenicity profiles were very similar between the two vaccines)”. – by Kate Sherrer
Henry O, et al. Abstract #1685. Presented at: IDWeek; October 25-30, 2016; New Orleans.
Disclosure: This study was funded by GlaxoSmithKline. Henry is an employee and shareholder at GlaxoSmithKline. Please see the full study for a list of all other researchers’ financial relationships.