drugset / Trial / NCT03148990

Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella

NCT03148990 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2018-11-20
Primary completion
2020-08-12
Completion
2020-08-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Measles and Rubella vaccine Vaccine — —
Comparator Measles, Mumps and Rubella vaccine Vaccine — —

Indications