文本框: CLINICAL PROFILE OF A NEW MMR VACCINE
Usonis V.
Vilnius University, Vilnius, Lithuania

Objective: To evaluate the clinical safety of the novel live attenuated  GlaxoSmithKline measles–mumps–rubella vaccine Priorix™.
Methods: Reactogenicity of the Priorix™ vaccine was compared with the Merck & Co Inc. M-M-R-II® vaccine in eight single-blind, randomized, controlled clinical studies. A total of 4,581 healthy children, aged 9 to 24 months were given either Priorix™ (3507) or MMR-II® (1195) vaccine. Local and general reactions were evaluated by analyzing diary cards completed by parents.
Results: The incidence of local symptoms at the injection site, recorded immediately after vaccination and within 4 days after vaccination was statistically lower in the Priorix™ group than in the MMR-II® group: pain immediately after injection – 19.1% and 28.7%; pain – 4.0% and 8.6%; redness – 9.8% and 16.3%; swelling – 3.5% and 7.4%. There were no significant differences observed in the incidence of general symptoms in both groups: fever over 38.1oC – 38.0% in Priorix™ and 39.7% in MMR-II® group; fever over 39.5oC – 9.5% and 11.9%; rash – 7.8% and 9.8%; salivary gland swelling – 0.4% and 0.5%. The time of the onset of fever was similar in both groups with the peak occurring during the second week after vaccination.
Conclusion: The clinical safety of Priorix™ when administered as primary vaccination in the second year of life has been shown to be comparable to MMR-II®.