CTRI/2024/11/077318进行中（未招募）4 期
A phase IV, double blind, randomized, active control clinical study comparing safety and immunogenicity of SII-Measles-Mumps- Rubella vaccine with PRIORIX (GSK) in healthy infants in India
Serum institute of India Pvt Ltd Pune6 个研究点 分布在 1 个国家目标入组 429 人开始时间: 2025年1月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 429
- 试验地点
- 6
- 主要终点
- Proportion of study participants with seropositivity for measles, mumps and rubella
研究概览
简要总结
This is a randomized, double blind, active control, multi-center clinical study to evaluate and compare immunogenicity and safety of two doses of SII-MMR vaccine with two doses of Priorix in 429 healthy Indian infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 9.00 Month(s) 至 11.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy male and female infants between 9 months and 11 months old 2) Parent of study participant willing to give written informed consent.
- •Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
排除标准
- •Acute illness
- •Congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy
- •History of allergy or systemic hypersensitivity to any of the vaccine component or to a vaccine containing the same substances
- •Acute or chronic, clinically significant systemic disorder/disease
- •History of measles, mumps, or rubella infection
- •Previous history of Measles/Rubella/MR/MMR vaccination.
结局指标
主要结局
Proportion of study participants with seropositivity for measles, mumps and rubella
时间窗: 41 days after the second dose of the study vaccine
次要结局
- Geometric Mean titers (GMT) for anti-measles, anti-mumps and anti-rubella antibodies mumps and rubella 41 and 179 days after the first dose of the study vaccine(At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine)
- Proportion of study participants with seropositivity for measles, mumps and rubella(41 and 179 days after the first dose of study vaccine)
- Proportion of study participants with seroconversion for measles, mumps and rubella(At 41 and 179 days after the first dose, and 41 days after the second dose of study vaccine)
- Proportion of study participants with seroresponse for measles,(mumps and rubella)
- Solicited adverse events(through 14 days following each dose of the study vaccine.)
- Unsolicited adverse events(through 41 days following each dose of the study vaccine)
- Serious adverse events(Throughout study participation)
研究者
Dr Prasad Kulkarni
Serum Institute of India Pvt Ltd. Pune India
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421ANCT07444762Daewon Pharmaceutical Co., Ltd.184
招募中
2/3 期
A Study to check Immunogenicity and Safety of A Trivalent Nanoparticle Influenza Vaccine and Covid-Influenza Combination Vaccine in AdultsCTRI/2025/10/095731Serum Institute of India Private Limited (SIIPL)2,400
招募中
4 期
A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye DiseaseThyroid Eye DiseaseNCT07265258Innovent Biologics (Suzhou) Co. Ltd.92
尚未招募
3 期
IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular LymphomaNCT07355283ImmuneOnco Biopharmaceuticals (Shanghai) Inc.198
招募中
2 期
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma PatientsAllergic AsthmaNCT07342803Longbio Pharma200