drugset / Trial / NCT03148990
Study to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella
Phase 2/3
Completed
432 enrolled
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Oswaldo Cruz Institute · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Measles and Rubella vaccine | Vaccine | — | — |
| Comparator | Measles, Mumps and Rubella vaccine | Vaccine | — | — |