NCT03713359

Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC (Phase III)

Randomized, Controlled Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC by Technology Transfer From Japan (Phase III)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 756 (actual)
• Sponsor: Center for Research and Production of Vaccines and Biologicals, Vietnam · Other Government
• Sex: All
• Age: 12 Months – 45 Years
• Healthy volunteers: Accepted

Summary

The study is conducted to evaluate the safety and Immunogenicity of Measles-Rubella combined vaccine MRVAC produced by POLYVAC (phase 3) on Vietnamese volunteers and to demonstrate non-inferiority on the immunogenicity of MRVAC in comparison to MR vaccine produced by Serum Institute, India.

Detailed description

A phase III, Randomized, control study to compare the immunogenicity and safety of MRVAC vaccine produced by POLYVAC with MR vaccine licensed in Vietnam produced by Serum Institute, India. 1. Evaluate the safety of MRVAC produced by POLYVAC on Healthy Vietnamese volunteers from 1 - 45 years old. Evaluate the safety by the ratio of participants having following symptom/signs: * The ratio of immediate adverse events (local adverse events and systemic adverse events), within 30 minutes after vaccination. * The ratio of participants having local and systemic adverse events (including unexpected adverse events) occur within 28 days after vaccination. * The ratio of serious adverse events (SAEs) occur from day 0 to day 28 after vaccination. (SAEs). 2. Evaluate the immunogenicity of MRVAC produced by POLYVAC on the healthy volunteers from 1 - 45 years. * The rate of sero-conversion; * GMT (Geomatric mean Antibody titer) after vaccination. 3. Comparison the safety and immunogenicity between MRVAC and control vaccine.

Conditions

• Signs and Symptoms

Interventions

Type	Name	Description
BIOLOGICAL	Trial arm (MRVAC)	Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
BIOLOGICAL	Control arm	Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-07-01
• Completion: 2016-11-01
• First posted: 2018-10-19
• Last updated: 2018-10-19