A prospective, randomized, two arm, parallel, activecontrolled, multicentre, phase III clinical study tocompare the immunogenicity and safety of InactivatedInfluenza vaccine (split virion) I.P. (Tetravalent) 0.5mlof M/s Cadila Healthcare Limited with Fluarix-Tetra ofM/s GlaxoSmithKline Pharmaceuticals Limited inhealthy children aged 6 to 35 months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 346
- 试验地点
- 5
- 主要终点
- Seroprotection rate for all the four viral strains in the two groups at the end of the study
研究概览
简要总结
This is A prospective, randomized, two arm, parallel, active controlled, multicentre, phase III clinical study to compare the immunogenicity and safety of Inactivated Influenza vaccine (split virion) I.P. (Tetravalent) 0.5ml of M/s Cadila Healthcare Limited with Fluarix-Tetra of M/s GlaxoSmithKline Pharmaceuticals Limited. A total of 346 healthy children aged 6 to 35 months will be enrolled in this study. The primary objective of this clinical study is to compare Seroprotection rate for all the four viral strains in the two groups at the end of the study. The secondary objective is to evaluate the Immunogenicity and Safety of the vaccines. For immunogenicity - Seroconversion rate for all the four viral strains in the two groups at the end of study and Geometric mean titres for all the four viral strains in the two groups at the end of the study will be eavaluated. For Safety Safety: 1. Solicited local and systemic adverse events reported during the study, 2. Unsolicited adverse events reported during the study, 3. Serious adverse events reported during the study will be evaluated.
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
- 6.00 Month(s) 至 35.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy subject of either gender 6 months to 35 months of age at the time of enrolment
- •Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
- •Informed consent from the parents of subjects.
- •Parents of subjects literate enough to fill the diary card.
排除标准
- •Past history of hypersensitivity reaction, neurological disorder (Guillain–Barré syndrome or others) or any serious adverse event to any vaccine, egg, chicken proteins, aminoglycoside antibiotics
- •Subjects with history of administration of any influenza vaccine or subjects with laboratory confirmed influenza in past
- •Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •Subjects with febrile illness (body temperature ≥ 37.5°C) at the time of enrolment, or acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •Any other vaccine administration within the last 30 days or planned to be administered during the study period
- •Participation in another clinical trial in the past 3 months
- •Have any condition that in opinion of the investigator would make the subject unsuitable for participation in the study.
结局指标
主要结局
Seroprotection rate for all the four viral strains in the two groups at the end of the study
时间窗: Day 56
次要结局
- Safety:(1. Solicited local and systemic adverse events reported during the study)
- Seroconversion rate for all the four viral strains in the two groups at the end of study(Day 56)
- Geometric mean titres for all the four viral strains in the two groups at the end of the(study)