A randomized, open label, multicentric, phase II clinical trial to assess the immunogenicity and safety of Measles, Mumps and Rubella (MMR) vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 15-18 months
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- The primary immunogenicity criteria will be the seroconversion rate for measles, mumps and rubella
研究概览
简要总结
This is a randomized, open label, parallel group, multicentric, phase II clinical trial to assess the immunogenicity and safety of Measles, Mumps and Rubella (MMR) vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. (CHL) in healthy paediatric subjects aged 15-18 months. Hundred subjects will be randomized to receive MMR vaccine from either a single dose vial or a multidose vial. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine antibody titres attained after vaccination. The primary immunogenicity criteria will be the seroconversion rate which would be estimated as follows: 1.The percentage of subjects who had been seronegative before vaccination and who developed antibody concentrations of ≥ 200 Milli International Unit (mIU)/ml for measles, ≥ 8 ELISA units (U)/ml for mumps and ≥ 8 International Unit (IU)/ml for rubella 42 days following vaccination. 2. The percentage of subjects who were already seropositive for measles / mumps / rubella at the time of immunization and developed a ≥ 4 fold increase in the respective antibody titers 42 days following vaccination. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Month(s) 至 18.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Healthy pediatric subjects of either sex aged 15 months to 18 months.
- •2.Informed consent of the parents/guardians and their willingness to be followed up for at least 6 weeks after vaccination of their child.
- •3.Parents/guardians with adequate literacy to fill the diary cards.
排除标准
- •1.Subjects with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to neomycin.
- •2.Subjects with a history of previous measles, mumps or rubella infection or MMR vaccination, or if they had been exposed to any of these three diseases within 30 days of trial commencement.
- •3.Subjects having received measles vaccine less than 3 months back.
- •4.A history of convulsions, epilepsy or other central nervous system diseases or an acute febrile illness at the time of planned vaccination.
- •5.Any other parenteral vaccine administration within 30 days of initiation of the study or during the study.
- •6.A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy).
- •7.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
- •8.Subjects with any other clinically significant concurrent illness.
结局指标
主要结局
The primary immunogenicity criteria will be the seroconversion rate for measles, mumps and rubella
时间窗: 42 days following vaccination
次要结局
- The secondary immunogenicity criteria will be the post-vaccination geometric mean titers (GMTs) of antibodies to measles, mumps and rubella(42 days following vaccination)