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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
756
Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
Adverse events
1\. Incidence rate of local adverse event (AE), systemic AE
Time frame: During 30 minutes and 28 days after only one dose vaccination
Antibody seroconversion
Positive seroconversion rates of Measles and Rubella neutralization antibody
Time frame: 42 to 56 days after only one dose vaccination .
Geo-mean antibody titer
Geo-mean antibody titer of both trial arm and control arm
Time frame: Before vaccination and after 42 to 56 days vaccination only one dose
Serious adverse event (SAE)
Number of cases occur SAEs
Time frame: During 30 minutes and 28 days after vaccination only one dose
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