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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase II / III, Clinical Trial to Evaluate the Immunogenicity, Reatogenicity and Safety of Double Viral Vaccine (MR) for Measles and Rubella, Produced by Bio-Manguinhos

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-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.

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

Current Primary Outcome: Immunogenicity analysis of the study vaccine [ Time Frame: 42 days after the 1st dose of MR or MMR ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Reatogenicity analysis of the study vaccine [ Time Frame: 30 days after the 1st dose of MR or MMR ]

To assess the occurrence of serious adverse events among individuals who received MR and MMR vaccines.


Original Secondary Outcome: Same as current

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

Dates:
Date Received: May 9, 2017
Date Started: January 8, 2018
Date Completion: November 30, 2018
Last Updated: May 9, 2017
Last Verified: April 2017