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

NCT02196285 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-06-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Double viral (MR) vaccine

Measles and Rubella vaccine, as single arm

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

    lead OTHER

Principal Investigators

  • Jose CerbinoNeto, PHD · Unidade de Ensaios Clínicos para Imunobiológicos, Fiocruz

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02196285 on ClinicalTrials.gov