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

NCT03713359 | Completed Phase 3 DMC

• 1 other identifier: MRVAC VX.2016.01
• Study Type: interventional
• Target: 756
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Signs and Symptoms

Keywords

MRVAC vaccine, fever, rash

Outcome Measures

Primary Outcomes (1)

• Adverse events

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

  During 30 minutes and 28 days after only one dose vaccination

Secondary Outcomes (3)

• Antibody seroconversion

  42 to 56 days after only one dose vaccination .

• Geo-mean antibody titer

  Before vaccination and after 42 to 56 days vaccination only one dose

• Serious adverse event (SAE)

  During 30 minutes and 28 days after vaccination only one dose

Study Arms (2)

Trial arm (MRVAC)

ACTIVE COMPARATOR

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)

Control arm

ACTIVE COMPARATOR

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

Interventions

Trial arm (MRVAC) BIOLOGICAL

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

Trial arm (MRVAC)

Control arm BIOLOGICAL

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

Control arm

Eligibility Criteria

• Age: 12 Months - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Center for Research and Production of Vaccines and Biologicals, Vietnam: lead
• Vietnam Military Medical University: collaborator

MeSH Terms

Conditions

Signs and Symptoms; Fever; Exanthema

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dinh H. Duong, Ph.D

  Epidemiology department - Vietnam Military Medical University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 19, 2018
• Study Start: April 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 19, 2018

Record last verified: 2018-10