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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Current Primary Outcome: Safety and tolerability analysis of the study vaccine [ Time Frame: 9 months ]

To evaluate the occurrence of serious adverse events among the subjects who have received study vaccine.


Original Primary Outcome: Same as current

Current Secondary Outcome: Imunogenicity analysis [ Time Frame: 9 months ]

To evaluate imune response between post and pre-vaccination antibodies.


Original Secondary Outcome: Same as current

Information By: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Dates:
Date Received: July 16, 2014
Date Started: September 2015
Date Completion:
Last Updated: June 21, 2016
Last Verified: June 2016