Priorix, M-M-R II demonstrate similar immune responses, safety profiles
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A measles-mumps-rubella vaccine developed by GlaxoSmithKline was found to have immune response rates and a safety profile similar to the Merck vaccine, according to results from a phase 3 clinical trial presented at IDWeek 2016.
“Measles, mumps and rubella 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 and was licensed in 1979. Currently, GlaxoSmithKline 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 GSK’s MMR vaccine (Priorix), the immunogenic noninferiority of three pooled lots of the Priorix vaccine compared with Merck’s MMR vaccine (M-M-R II), and the reactogenicity and immune response rate of Priorix.
The investigators enrolled approximately 5,000 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 noninferior to Merck’s MMR vaccine,” Klein told Infectious Disease News. “GSK’s MMR vaccine demonstrated an acceptable immune response against measles, mumps and rubella; and no safety concerns were identified.” – by Kate Sherrer
- Reference:
- Henry O, et al. Abstract 1685. Presented at: IDWeek; October 25-30, 2016; New Orleans.
Disclosure: The study was funded by GlaxoSmithKline. One of the researchers is an employee and shareholder at GlaxoSmithKline. Please see the full study for a list of all other authors’ relevant financial disclosures.