NCT02196285

Study to Evaluate Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella

A Phase I, Open, Uncontrolled Study, to Evaluate the Safety and Imunogenicity of Double Viral Vaccine (MR) for Measles and Rubella in Young Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Academic / Other
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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, open study, non-controlled, to evaluate the safety, tolerability and imunogenicity of 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. 30 eligible volunteers, between 18-49 years old, will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 20 months in total.

Detailed description

This is a Phase I, open study, non-controlled, to evaluate the safety, tolerability and imunogenicity of 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. 30 eligible volunteers, between 18-49 years old, will be vaccinated and monitored for local and systemic adverse events and titration of antibodies. The study will last 20 months in total.

Conditions

• Rubella
• Measles

Interventions

Type	Name	Description
BIOLOGICAL	Double viral (MR) vaccine	Measles and Rubella vaccine, as single arm

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2014-07-22
• Last updated: 2016-06-22

Locations

1 site across 1 country: Brazil