Signs and SymptomsPhase 3NCT03713359
Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC (Phase III)
A Phase 3 study testing Trial arm (MRVAC) in people with Signs and Symptoms, run by Center for Research and Production of Vaccines and Biologicals, Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms
- What is being tested?
- Trial arm (MRVAC)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
About this study
Official title: Randomized, Controlled Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC by Technology Transfer From Japan (Phase III)
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.
Read the 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.
- Conditions
- Signs and Symptoms
- Being tested
- Trial arm (MRVAC), Control arm
- Keywords
- MRVAC vaccine, fever, rash
- Medical subject headings
- Signs and Symptoms, Fever, Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trial arm (MRVAC)Biological
Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
Control armBiological
Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
- Incidence rate of local adverse event (AE), systemic AE
Measured: During 30 minutes and 28 days after only one dose vaccination
Secondary outcomes (3)
Antibody seroconversion
Positive seroconversion rates of Measles and Rubella neutralization antibody
Measured: 42 to 56 days after only one dose vaccination .
Geo-mean antibody titer
Geo-mean antibody titer of both trial arm and control arm
Measured: Before vaccination and after 42 to 56 days vaccination only one dose
Serious adverse event (SAE)
Number of cases occur SAEs
Measured: During 30 minutes and 28 days after vaccination only one dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study startApr 2016
- Primary completionJul 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Research and Production of Vaccines and Biologicals, Vietnam
- Sponsor type
- Other government
- Collaborators
- Vietnam Military Medical University
- Responsible party
- Sponsor
- Investigators
- Dinh H. Duong, Ph.D, Principal investigator, Epidemiology department - Vietnam Military Medical University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713359
- Sponsor's protocol ID
- MRVAC VX.2016.01
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC by Technology Transfer From Japan (Phase III)
- ClinicalTrials.gov ID
- NCT03713359
- Acronym / sponsor ID
- MRVAC VX.2016.01
- Conditions
- Signs and Symptoms
- Keywords
- MRVAC vaccine, fever, rash
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Center for Research and Production of Vaccines and Biologicals, VietnamOther government
- Collaborators
- Vietnam Military Medical University
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Trial arm (MRVAC) | Active comparator | Biological: 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 |
| Control arm | Active comparator | Biological: Control armMeasles 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 |
Who may qualify
- Ages
- 12 months to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- For children 1-2 years old: All subjects must meet all of the following criteria at the time of enroll to stduy:
- For people from 1 year to 45 years old:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trial arm (MRVAC)Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine | Biological | Trial arm (MRVAC) |
| Control armVolunteers from 1-45 years old will be injected only one dose of MRVAC vaccine | Biological | Control arm |
Primary outcome
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
3 secondary outcomes
Antibody seroconversion
Time frame: 42 to 56 days after only one dose vaccination .
Geo-mean antibody titer
Time frame: Before vaccination and after 42 to 56 days vaccination only one dose
Serious adverse event (SAE)
Time frame: During 30 minutes and 28 days after vaccination only one dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinh H. Duong, Ph.D principal investigator
Epidemiology department - Vietnam Military Medical University.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trial arm (MRVAC) in people with Signs and Symptoms, run by Center for Research and Production of Vaccines and Biologicals, Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: During 30 minutes and 28 days after only one dose vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.