Immunogenicity and safety of the combined vaccine for measles, mumps, and rubella isolated or combined with the varicella component administered at 3-month intervals: randomised study

xmlui.dri2xhtml.METS-1.0.item-date
2019xmlui.mirage2.itemSummaryView.MetaData
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http://patua.iec.gov.br//handle/iec/3619xmlui.dri2xhtml.METS-1.0.item-author
Santos, Eliane Matos dos
Noronha, Tatiana Guimarães
Alves, Isabelle Soares
Cruz, Robson Leite de Souza
Ferroco, Clara Lucy de Vasconcelos
Brum, Ricardo Cristiano
Oliveira, Patricia Mouta Nunes de
Siqueira, Marilda Mendonça
Lima, Mariza Cristina
Ramos, Francisco Lúzio de Paula
Bragagnolo, Camila de Marco
Camacho, Luiz Antonio Bastos
Maia, Maria de Lourdes de Sousa
xmlui.dri2xhtml.METS-1.0.item-abstract
BACKGROUND Field testing required to license the combined measles, mumps, and rubella (MMR) vaccine must take into
account the current recommendation of the vaccine in Brazil: first dose at 12 months and second dose at 15 months of age in
combination with a varicella vaccine.
OBJECTIVES This study aimed to evaluate the clinical consistency, immunogenicity, and reactogenicity of three batches of MMR
vaccine prepared with active pharmaceutical ingredients (API) from Bio-Manguinhos, Fiocruz (MMR-Bio), and compare it to a
vaccine (MMR produced by GlaxoSmithKline) with different API.
METHODS This was a phase III, randomised, double-blind, non-inferiority study of the MMR-Bio administered in infants
immunised at health care units in Pará, Brazil, from February 2015 to January 2016. Antibody levels were titrated by
immunoenzymatic assays. Adverse events were recorded in diaries.
FINDINGS Seropositivity levels after MMR-Bio were 97.6% for measles, 84.7% for mumps, and 98.0% for rubella. After the
MMRV vaccine, seroconversion rates and GMT increased substantially for mumps. In contrast, approximately 35% of the
children had no detectable antibodies to varicella. Systemic adverse events were more frequent than local events.
CONCLUSION The demonstration of batch consistency and non-inferiority of the Bio-MMR vaccine completed the technology
transfer. This is a significant technological achievement with implications for immunisation programs.
xmlui.dri2xhtml.METS-1.0.item-citation
SANTOS, Eliane Matos dos et al. Immunogenicity and safety of the combined vaccine for measles, mumps, and rubella isolated or combined with the varicella component administered at 3-month intervals: randomised study. Memórias do Instituto Oswaldo Cruz, v. 114, e180517, Mar. 2019.xmlui.dri2xhtml.METS-1.0.item-decsPrimary
Vacinação / métodosVacina contra Sarampo-Caxumba-Rubéola / uso terapêutico
Vacina contra Sarampo-Caxumba-Rubéola / efeitos adversos
Imunogenicidade da Vacina / efeitos dos fármacos
Programas de Imunização
Estudos de Validação como Assunto