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

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ClinicalTrials.gov Identifier: NCT03713359
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Vietnam Military Medical University
Information provided by (Responsible Party):
Center for Research and Production of Vaccines and Biologicals, Vietnam

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.

Condition or disease Intervention/treatment Phase
Signs and Symptoms Biological: Trial arm (MRVAC) Biological: Control arm Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible participants will be randomized receiving either MRVAC or MR vaccine produced by Serum Institute, India, which was using in Vietnam National Expanded program on Immunization in the ratio of 2:1. The Participants will be received only 1 dose of vaccine at the age from 1 year to 45 years.
Masking: Single (Participant)
Masking Description: The first two volunteers will be assigned to the MRVAC group (code named A) and coded A001 and A002. The 3rd Volunteer will be assigned to the control group (code named B) and coded as B001. Volunteers arriving later will also be coded in this order until they meet enough subjects as required.
Primary Purpose: Prevention
Official Title: Randomized, Controlled Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC by Technology Transfer From Japan (Phase III)
Actual Study Start Date : April 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Rubella

Arm Intervention/treatment
Active Comparator: Trial arm (MRVAC)

Measles and Rubella combined vaccine (lyophilized) MRVAC produced by POLYVAC is live attenuated measles vaccine. Each vial of 10 doses of measles-rubella combined vaccine is reconstituted with 5.5 mL of water for injection. Each single dose 0.5 mL contains the following components:

Live, attenuated strain AIK-C measles virus not less than 1000 PFU Live, attenuated strain Takahashi rubella virus not less than 1000 PFU Subcutaneous injection

Biological: Trial arm (MRVAC)
Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine

Active Comparator: Control arm

Measles and Rubella combined vaccine produce by Serum Institute, India (lyophilized) is live attenuated Measles and Rubella vaccines being used in the Vietnam expanded immunization program was used as control arm.

Subcutaneous injection

Biological: Control arm
Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine




Primary Outcome Measures :
  1. Adverse events [ Time Frame: During 30 minutes and 28 days after only one dose vaccination ]
    1. Incidence rate of local adverse event (AE), systemic AE


Secondary Outcome Measures :
  1. Antibody seroconversion [ Time Frame: 42 to 56 days after only one dose vaccination . ]
    Positive seroconversion rates of Measles and Rubella neutralization antibody

  2. Geo-mean antibody titer [ Time Frame: Before vaccination and after 42 to 56 days vaccination only one dose ]
    Geo-mean antibody titer of both trial arm and control arm

  3. Serious adverse event (SAE) [ Time Frame: During 30 minutes and 28 days after vaccination only one dose ]
    Number of cases occur SAEs



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • For children 1-2 years old: All subjects must meet all of the following criteria at the time of enroll to stduy:

    • Healthy children from 1 year to 2 years old.
    • Full-term birth: Pregnancy ≥ 37 weeks.
    • Weight at birth is at least 2.5kg.
    • Do not get any disease through a clinical examination and ask for medical history before taking part in the study (according to the prescribed information).
    • Have not injected Rubella vaccine or a combination vaccine containing Rubella vaccine.
    • Have not infected by Rubella before.
    • Parents or legal guardians agree to voluntarily consent to their child's participation in the study. Parent or legal guardian is provided basic information about the vaccine as well as benefits, obligations and meaning of participating in the trial. There must be a written consent form for your child to participate.
  • For people from 1 year to 45 years old:

    • Do not get any disease through a clinical examination and ask for medical history before taking part in the study (according to the prescribed card).
    • Have not infected by Rubella before.
    • For people over 2 years old up to 18 years old: Parents or legal guardians agree to voluntarily consent to their child's participation in the study. Parent or legal guardian is provided basic information about the vaccine as well as benefits, obligations and meaning of participating in the trial. There must be a written consent form for your child to participate.
  • For people aged 18 to 45: Completely volunteering to participate in the study after having been provided with basic information about the trial vaccine as well as the benefits, obligations and meaning of the trial participation. Must sign in the consent form to participate in the study.

Exclusion Criteria:

  • Fever within 3 days before vaccination (body temperature ≥ 38 degrees Celsius) Persons with congenital malformations, neurological disorders, psychiatric disorders or families with neurological or psychiatric conditions or brain damage.
  • Having abnormal immune status or being treated for immunological control; Being immunocompromised as a result of progressive disease treatment.
  • Have received immunosuppressive drugs (steroid group) for more than 2 weeks before starting the vaccination.
  • Allergy to any vaccine component including hypersensitivity reactions and anaphylactic shock to the antibiotics (Kanamycine and Erythromycin), egg products and gelatin.
  • Family history of immunodeficiency.
  • Have a history of high fever, seizures
  • premature birth (<37 weeks) (applicable to children 1-2 years).
  • Malnutrition level 3 or above (applicable to children 1-2 years).
  • Have used of gamma globulin, blood transfusions within 3 months before vaccination or gamma glubolin in large doses or the use of immunosuppressive drugs within 6 months before vaccination
  • Have used live vaccines within 27 days before vaccination; Have used other vaccines within 4 weeks before entry to study; Use of immunoglobulins or blood products within 3 months before vaccination;
  • Is participating in trial other drugs or vaccines; Has an acute or chronic disease that affects the safety (including but not limited to: chronic liver disease, some kidney disease, progressive or unstable neurological disorders, diabetes and organ transplants).
  • Having serious acute illness. Responsible doctor or doctor in charge of evaluation consider as unsuitable, such as having abnormal crying ...
  • Having plan to go far from the study site between visits. - Being pregnant (for women aged 14 - 45 years)
  • Trial subjects must satisfy selection criteria and not be subjected to exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713359


Sponsors and Collaborators
Center for Research and Production of Vaccines and Biologicals, Vietnam
Vietnam Military Medical University
Investigators
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Principal Investigator: Dinh H. Duong, Ph.D Epidemiology department - Vietnam Military Medical University.

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Responsible Party: Center for Research and Production of Vaccines and Biologicals, Vietnam
ClinicalTrials.gov Identifier: NCT03713359     History of Changes
Other Study ID Numbers: MRVAC VX.2016.01
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Center for Research and Production of Vaccines and Biologicals, Vietnam:
MRVAC vaccine, fever, rash

Additional relevant MeSH terms:
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Signs and Symptoms
Rubella
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs