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

NCT03148990 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2020-08-13

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-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.

Conditions

Interventions

BIOLOGICAL

Measles and Rubella vaccine

Administration of the experimental vaccine (MR).

BIOLOGICAL

Measles, Mumps and Rubella vaccine

Administration of the comparator vaccine (MMR).

Sponsors & Collaborators

  • Oswaldo Cruz Institute

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Kleber G Luz, PhD · Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Months
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-08-12
Completion
2020-08-12

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 NCT03148990 on ClinicalTrials.gov