Randomized, Controlled Clinical Trial for Measles - Rubella Combined Vaccine (MRVAC) Produced by POLYVAC by Technology Transfer From Japan (Phase III)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 756
- 主要终点
- Adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 12 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Trial arm (MRVAC) (Biological)
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
干预措施: Control arm (Biological)
结局指标
主要结局
Adverse events
时间窗: During 30 minutes and 28 days after only one dose vaccination
1. Incidence rate of local adverse event (AE), systemic AE
次要结局
- 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)