A prospective, randomized, parallel, single-blind,four-arm, active-controlled, multicentre, phase IV clinical trial to evaluate immunogenicity and safety of MR vaccine of M/s. Zydus Lifesciences Ltd. vs. MR vaccine of M/s. Serum Institute of India Pvt.Ltd. and to evaluate lot-to-lot consistency of MR vaccine of M/s. Zydus Lifesciences Ltd. in healthy infants aged 9-12 months.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,428
- 试验地点
- 24
- 主要终点
- 1)Non-inferiority for seropositivity rate for anti-measles and anti-rubella IgG
研究概览
简要总结
This will be a randomized, multicentre study in which the subjects would be administered a single dose of either MR vaccine M/s. Zydus Lifesciences Ltd. (test vaccine) or MR vaccine of M/s. Serum Institute of India Pvt. Ltd. (reference vaccine) at enrollment and then the subjects will be followed up for 6 months immunogenicity and safety evaluation. To evaluate lot-to-lot consistency of the test vaccine, 3 different batches of the vaccine will be used in the study. Anti-measles and anti-rubella IgG antibodies will be assessed from the samples collected prior to vaccination and 42 days & 180 days after vaccination using commercially available ELISA kits at the central laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 9.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy infant subject of either sex aged 9 to 12 months at the time of enrollment
- •Subjects should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator
- •No previous history of vaccination against measles and rubella
- •Written informed consent from the subject’s parent (mother/father)
- •Subject’s parent literate enough to fill the diary card
- •Subjects and parents likely to be available for follow-up for entire duration of the study.
排除标准
- •History of hypersensitivity reaction to any component of the vaccines
- •History of hypersensitivity reaction to neomycin
- •History of laboratory confirmed or suspected measles or rubella in past
- •History of any vaccination against measles or rubella in past
- •Subject exposed to measles or rubella virus within the past 30 days
- •Fever of any origin or infectious disorder of 3 days or more within the past 30 days
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, immunological, metabolic or major congenital disorder
- •Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •Subject participated in another clinical study in the past 3 months
- •Any other reason for which the investigator feels that subject should not participate.
结局指标
主要结局
1)Non-inferiority for seropositivity rate for anti-measles and anti-rubella IgG
时间窗: Baseline (Day 0) and Day 42
antibodies at 42 days after vaccination between the test group and the
时间窗: Baseline (Day 0) and Day 42
reference group
时间窗: Baseline (Day 0) and Day 42
2)Lot-to-lot consistency of 3 batches of the test vaccine at 42 days after
时间窗: Baseline (Day 0) and Day 42
vaccination based on geometric mean titre ratio
时间窗: Baseline (Day 0) and Day 42
次要结局
- Seropositivity rate for anti-measles and anti-rubella IgG antibodies(Baseline (Day 0) and End of study (Day 180))
- Seroconversion rate for anti-measles and anti-rubella IgG antibodies(Baseline (Day 0), Day 42 and End of study (Day 180))
- Geometric mean titre of anti-measles and anti-rubella IgG antibodies(Baseline (Day 0), Day 42 and End of study (Day 180))
- Solicited local and systemic adverse events(Baseline (Day 0) to Day 14)
- Unsolicited adverse events(Baseline (Day 0) to End of study (Day 180))
- Medically attended adverse events(Baseline (Day 0) to End of study (Day 180))
- Serious adverse events(Baseline (Day 0) to End of study (Day 180))
研究者
Dr Pavankumar Daultani
Zydus Lifesciences Ltd