Measles and rubella are highly contagious acute viral diseases. As per WHO, several evidences demonstrate the benefit for providing the universal access to vaccines containing measles and rubella antigens, mainly due to, respectively, mortality in children and malformations in fetuses. This is a Phase I-III, Controlled, randomized and double blind for the evaluation double viral vaccine anti-measles and rubella (MR), which is developed and produced at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 11 months in total.
This is a Phase II-III, controlled, randomized and double blind for the evaluation of a double viral vaccine anti measles and rubella (MR), which is under the development at Instituto de Tecnologia em Imunobiologicos Bio-Manguinhos/Fiocruz, in Brazil, for use in human beings. 432 eligible volunteers (11-month-old infants), will be vaccinated and monitored for local and systemic adverse events and immunogenicity. The study will last 11 months in total.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
432
Administration of the experimental vaccine (MR).
Administration of the comparator vaccine (MMR).
Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda (CPCLIN)
Natal, Rio Grande do Norte, Brazil
Secretaria Municipal de Saúde do Estado do Rio de Janeiro
Rio de Janeiro, Brazil
Immunogenicity analysis of the study vaccine
To evaluate imune response between post and pre-vaccination antibodies.
Time frame: 42 days after the 1st dose of MR or MMR
Reatogenicity analysis of the study vaccine
To assess the occurrence of serious adverse events among individuals who received MR and MMR vaccines.
Time frame: 30 days after the 1st dose of MR or MMR
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