A prospective, randomized, single blind,parallel, active controlled, multicentre, phase II /III clinical study to evaluate the immunogenicityand safety of Measles & Rubella vaccine (Live)I.P. (Freeze Dried) – Single Dose and MultiDose formulations of M/s Cadila HealthcareLimited compared to Measles and Rubellavaccine (Live) I.P. (Freeze Dried) of M/s SerumInstitute of India Limited in healthy paediatricsubjects aged 9-12 months
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 入组人数
- 615
- 试验地点
- 10
- 主要终点
- Proportion of subjects who are sero-positive for measles and rubella
研究概览
简要总结
This is a randomized, single blind, parallel group, multicentre, non-inferiority phase II / III clinical trial to evaluate the immunogenicity and safety of single-dose and multi-dose formulations of Measles & Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Cadila Healthcare Limited compared to Measles and Rubella vaccine (Live) I.P. (Freeze Dried) of M/s Serum Institute of India Limited in healthy paediatric subjects aged 9-12 months. Six hundred and fifteen subjects will be randomized to receive either MR vaccine (Live) (Freeze-dried) of M/s Cadila Healthcare Limited (single-dose or multi-dose formulation ) or MR vaccine (Live) (Freeze-dried) of Serum Institute of India Limited according to the centralized computer generated randomization plan and will be followed up for 6 months. A pre vaccination and a post vaccination (week 6) blood sample will be collected to determine antibody titres attained after vaccination using ELISA kit manufactured by IBL International GMBH Germany. A titre >200 Milli International Unit (mIU)/ml for measles and > 8 IU/ml for rubella 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 study (6 months)
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
- •Healthy paediatric subjects of either sex aged 9 months to 12 months
- •Informed consent of either parent (mother or father) and their willingness to be followed up for at least 6 months after vaccination of their child
- •Parents with adequate literacy to fill the diary cards.
排除标准
- •Subjects with a history of anaphylaxis or serious reactions to other vaccines, gelatin and / or albumin
- •Subjects with a history of previous measles / rubella infection or vaccination with measles / rubella containing vaccine or if they had been exposed# to measles or rubella virus within 30 days of trial commencement
- •Subjects with a history of convulsions, epilepsy, other central nervous system diseases, severe disease of haematopoietic system, decompensated heart disease or impaired renal function
- •Subjects with an acute febrile illness at the time of randomization
- •Any other vaccine administration within 30 days of initiation of the study
- •A history of serious chronic illness, major congenital defects, immunosuppression (immunosuppressive illness or therapy)
- •Subjects who have received blood, blood products or immunoglobulins during the preceding 3 months
- •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 for measles and rubella
时间窗: 6 weeks following vaccination
次要结局
- Geometric mean titre of anti-measles and anti-rubella antibodies(6 weeks following vaccination)
- Serious adverse events reported(6 weeks and 6 months following vaccination)
- Overall tolerability evaluation(6 weeks and 6 months following vaccination)
- Local and systemic adverse events(6 weeks and 6 months following vaccination)
- Seroconversion rate for measles and rubella in subjects who were seronegative(before randomization)