Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-02 @ 3:27 AM
Study NCT ID:
NCT03713359
Status:
COMPLETED
Last Update Posted:
2018-10-19
First Post:
2018-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC (Phase III)
Sponsor:
Center for Research and Production of Vaccines and Biologicals, Vietnam
Organization:
Study Overview
Official Title:
Randomized, Controlled Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC by Technology Transfer From Japan (Phase III)
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: