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

Primary Purpose

Signs and Symptoms

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Trial arm (MRVAC)
Control arm
Sponsored by
Center for Research and Production of Vaccines and Biologicals, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Signs and Symptoms focused on measuring MRVAC vaccine, fever, rash

Eligibility Criteria

12 Months - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Trial arm (MRVAC)

    Control arm

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Adverse events
    1. Incidence rate of local adverse event (AE), systemic AE

    Secondary Outcome Measures

    Antibody seroconversion
    Positive seroconversion rates of Measles and Rubella neutralization antibody
    Geo-mean antibody titer
    Geo-mean antibody titer of both trial arm and control arm
    Serious adverse event (SAE)
    Number of cases occur SAEs

    Full Information

    First Posted
    October 9, 2018
    Last Updated
    October 17, 2018
    Sponsor
    Center for Research and Production of Vaccines and Biologicals, Vietnam
    Collaborators
    Vietnam Military Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03713359
    Brief Title
    Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC (Phase III)
    Official Title
    Randomized, Controlled Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC by Technology Transfer From Japan (Phase III)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Center for Research and Production of Vaccines and Biologicals, Vietnam
    Collaborators
    Vietnam Military Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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. 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). 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. Comparison the safety and immunogenicity between MRVAC and control vaccine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Signs and Symptoms
    Keywords
    MRVAC vaccine, fever, rash

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    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
    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.
    Allocation
    Randomized
    Enrollment
    756 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Trial arm (MRVAC)
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Control arm
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Biological
    Intervention Name(s)
    Trial arm (MRVAC)
    Intervention Description
    Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    Control arm
    Intervention Description
    Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
    Primary Outcome Measure Information:
    Title
    Adverse events
    Description
    1. Incidence rate of local adverse event (AE), systemic AE
    Time Frame
    During 30 minutes and 28 days after only one dose vaccination
    Secondary Outcome Measure Information:
    Title
    Antibody seroconversion
    Description
    Positive seroconversion rates of Measles and Rubella neutralization antibody
    Time Frame
    42 to 56 days after only one dose vaccination .
    Title
    Geo-mean antibody titer
    Description
    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
    Title
    Serious adverse event (SAE)
    Description
    Number of cases occur SAEs
    Time Frame
    During 30 minutes and 28 days after vaccination only one dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dinh H. Duong, Ph.D
    Organizational Affiliation
    Epidemiology department - Vietnam Military Medical University.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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