Reactogenicity and immunogenicity of a new live attenuated combined measles, mumps and rubella vaccine in healthy children.

ABSTRACT

OBJECTIVE: To compare the reactogenicity and immunogenicity of a novel live attenuated measles-mumps-rubella vaccine, SB MMR (Priorix; SmithKline Beecham Biologicals), with a widely used MMR vaccine, Merck MMR (M-M-R II; Merck & Co. Inc). METHODS: A total of 4702 healthy children, ages 9 to 24 months, were enrolled in 8 single blind, randomized, controlled trials. Reactogenicity (local and general solicited symptoms and all unsolicited symptoms) was assessed for up to 42 days postvaccination. Immunogenicity [seroconversion rates and geometric mean titers (GMT)] was assessed at 42 or 60 days postvaccination in 1912 subjects in 7 studies. In two studies the persistence of the antibodies at Month 12 postvaccination was assessed in 201 subjects. RESULTS: Local symptoms (pain on or immediately after injection; pain, redness and swelling within 4 days of injection) were reported less frequently after SB MMR than Merck MMR (P < 0.0001). General symptoms and all other events were similar between the two groups. Fever >39.5 degrees C was reported after 9.5 and 11.9% of the SB MMR and Merck MMR doses, respectively. At Days 42 to 60 postvaccination seroconversion rates for antimeasles antibodies were higher with SB MMR than with Merck MMR (98.7% vs. 96.9%, P < 0.031) but similar in both groups for anti-mumps and anti-rubella antibodies, GMTs being approximately 10% higher (P < 0.05) with Merck MMR than with SB MMR. At the Month 12 assessment the seropositivity rates and GMTs were similar in both groups. CONCLUSION: When administered as primary vaccination in children in the second year of life, the new SB MMR vaccine has been shown to be superior to a comparator vaccine in terms of local reactogenicity, with equivalent immunogenicity.