An evaluation of the adverse reaction potential of three
measles-mumps-rubella combination vaccines.
Dos Santos BA, Ranieri TS, Bercini M, Schermann MT, Famer S, Mohrdieck R,
Maraskin T, Wagner MB.
Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Porto
Alegre, Rio Grande do Sul, Brasil.
OBJECTIVE: To compare the incidence of adverse events following the
administration of three commercially available measles-mumps-rubella (MMR)
combination vaccines. METHODS: A randomized double-blind clinical trial was
performed in 1996 that involved a total of 10 142 students 6-12 years of age
in the state of Rio Grande do Sul, in Brazil. An MMR vaccine containing the
Edmonston-Zagreb, Leningrad-Zagreb, and RA 27/3 strains ("vaccine A") was
administered to 2 226 students (21.9% of the total); an MMR vaccine with the
Moraten, Jeryl Lynn, and Wistar 27/3 strains ("vaccine B") was administered to
2 216 children (21.8%); and an MMR vaccine containing the Schwartz, Urabe
AM-9, and Wistar 27/3 strains ("vaccine C") was given to 2 179 students
(21.5%). A control group of 3 521 students (34.7%) was not vaccinated. Both
the vaccinated subjects and the control subjects were followed daily for 30
days to detect any clinical manifestations. RESULTS: Adverse events were more
frequent in the vaccinated children than in the control group (P < 0.01). In
terms of causing parotitis, vaccine A had a relative risk (RR) of 5.72 (95%
confidence interval (CI) = 3.11-10.54) when compared with vaccine B, and an RR
of 2.33 (95% CI = 1.52-3.58) when compared with vaccine C. Vaccine A was also
associated with an increased risk of lymphadenopathy when compared with
vaccine B (RR = 3.11; 95% CI = 1.78-5.45) and with vaccine C (RR = 2.22; 95%
CI = 1.35-3.66). Vaccine C was associated with an increased risk of parotitis
when compared with vaccine B (RR = 2.46; 95% CI = 1.26-4.80). Three cases of
aseptic meningitis were detected among the children in the study group, but
only one case of vaccine-related aseptic meningitis was identified, among the
children receiving vaccine A. CONCLUSIONS: The three MMR vaccines that we
studied are associated with different risks of adverse events. We found
vaccine A to cause more reactions than the two other vaccines, especially
vaccine B. In addition, vaccine A presented both a temporal and a
cause-and-effect association with one case of aseptic meningitis. We hope that
this study will contribute information that can be used in choosing MMR
vaccines with safe and effective strains, especially for mass vaccination
strategies.
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