A prospective, randomized, single blind, parallel, active controlled, multicentre, non-inferiority, phase III clinical study to evaluate the immunogenicity and safety of single-dose and multi-dose vials of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to Measles vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 327
- 试验地点
- 7
- 主要终点
- Proportion of subjects who are sero-positive at the end of study in the two groups
研究概览
简要总结
This is a randomized, single blind, parallel group, multicentre, non-inferiority phase III clinical trial to evaluate the immunogenicity and safety of single-dose and multi-dose vials of Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited compared to Measles vaccine (Live) (Freeze-dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months. Three hundred and twenty seven subjects will be randomized to receive either Measles vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited (single-dose or multi-dose vial) or Measles vaccine (Live) (Freeze-dried) of Serum Institute of India Limited according to the centralized computer generated randomization plan. A pre vaccination and a post vaccination (day 42) blood sample will be collected to determine antibody titres attained after vaccination using ELISA kit manufactured by IBL International GMBH Germany. A titre >300 Milli International Unit (mIU)/ml will be considered as sero-positive. The primary efficacy end point will be the proportion of subjects who are sero-positive at the end of study in the two groups. The safety of the vaccine will be assessed by recording the adverse events occurring during the entire course of the studyxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •1.Healthy paediatric 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 other vaccines, gelatin and / or albumin 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.Subjects with a history of convulsions, epilepsy, other central nervous system diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function 4.Subjects with an acute febrile illness at the time of randomization 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, blood products or immunoglobulins during the preceding 3 months 8.Subjects with any other clinically significant concurrent illness affecting immune response after vaccination.
结局指标
主要结局
Proportion of subjects who are sero-positive at the end of study in the two groups
时间窗: 42 days following vaccination
次要结局
- •Geometric mean titre of anti-measles antibodies in the two groups at the end of the study(42 days following vaccination)
- •Sero-conversion rate in subjects who were sero-negative before randomization in the two groups at the end of the study(42 days following vaccination)