A randomized, open label, multicentric, phase II clinical trial to assess the immunogenicity and safety of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. in healthy pediatric subjects aged 9-12 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
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 safetyof Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Ltd. (CHL) inhealthy pediatric subjects aged 9-12 months. Hundred subjects will berandomized to receive Measles vaccine from either a single dose vial or amultidose vial. A pre vaccination and a post vaccination (day 42) blood samplewill be collected to determine antibody titres attained after vaccination. The primaryimmunogenicity criteria will be the seroconversion rate which would beestimated as follows: 1. The percentage of subjects who had been seronegativebefore vaccination and who developed antibody concentrations of ≥ 200 MilliInternational Unit (mIU)/ml for measles 42 days following vaccination. 2. The percentage of subjects who were alreadyseropositive for measles at the time of immunization and developed a ≥ 4 foldincrease in the respective antibody titers 42 days following vaccination. Thesafety of the vaccine will be assessed by recording the adverse eventsoccurring 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
- 9.00 Month(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •1.Healthy pediatric subjects of either sex aged 9 months to 12 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 infection or measles vaccination or if they had been exposed to measles virus within 30 days of trial commencement.
- •3.A history of convulsions, epilepsy or other central nervous system diseases or an acute febrile illness at the time of planned vaccination.
- •4.Any other parenteral vaccine administration within 30 days of initiation of the study or during the study.
- •5.A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy).
- •6.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
- •7.Subjects with any other clinically significant concurrent illness.
结局指标
主要结局
The primary immunogenicity criteria will be the
时间窗: 42 days | following | vaccination
seroconversion rate for measles
时间窗: 42 days | following | vaccination
次要结局
- The secondary immunogenicity criteria will be the postvaccination(geometric mean titers (GMTs) of antibodies to)