An open label phase-IV, label expansion study to evaluate the safety and immunogenicity of BE’s licensed Inactivated vero cell based Japanese Encephalitis Vaccine in ≥3 to 18 year old Indian children & adolescents in a two dose (0, 28D) schedule.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- 4.Rate of SAEs and medically attended AEs
研究概览
简要总结
This is a multicentre single arm open label post licensure label expansion study to evaluate safety and immunogenicity of BE’s inactivated vero cell derived Japanese Encephalitis vaccine in ≥3 to <18 year old Indian children & adolescents. This vaccine is proposed to be administered intramuscularly in two dose schedule with an interval of 28 days between doses. A total of 108 healthy Indian children and adolescent subjects of either gender will be enrolled. All eligible subjects would be randomised equally into three age subsets, =>3 to <8 years, =>8 to <12 years and =>12 to <18 year olds.
Sufficient blood sample will be drawn at baseline and again on 56th day for anti-JEV N antibody titre estimation. Routine laboratory tests will be done only twice during the study period, once at screening and again on 56th day, for hematological and biochemical parameters. Urine pregnancy will be done for women of child bearing potential at the time of screening, day 28 and at day 56.
This Phase-IV study is expected to provide safety and immunogenicity data on BE’s Inactivated Japanese Encephalitis vaccine in ≥3 to <18 year old Indian children & adolescents to obtain licensure in this age subset/group as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian subjects of either sex between ≥3 to <18 years at the time of 1st vaccination.
- •2.Free from clinically significant health problems as established by medical history and protocol specified clinical laboratory tests before entering into the study as judged by the Investigator.
- •3.Written informed consent obtained prior to screening from subject, subject’s parent/guardian or his/her legally acceptable representative.
- •An assent will also be obtained for children and adolescents (≥10 years to <18 years) where applicable prior to screening.
- •4.Ability of the subject, subject’s parent/guardian or his/her legally acceptable representative to understand and comply with the requirements of the protocol.
- •5.Female subjects with either no childbearing potential or, if after onset of menarche, a negative pregnancy test and a willingness to practice a reliable method of contraception.
- •6.Acceptable methods of birth control included barrier methods (including male and female condoms), diaphragms (cervical caps) with intra-vaginal spermicide (including jellies, foams and suppositories), intra-uterine devices, hormonal contraceptives, abstinence or same sex relationships.
排除标准
- •1.History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue fever 2.Planned administration of any other study vaccine during the study period.
- •3.Any family history of Immunodeficiency or autoimmune disease.
- •4.History of severe hypersensitivity reactions (in particular to a component of the investigational vaccine, anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission).
- •5.Any confirmed or suspected Infection with HIV, HBV and HCV.
- •6.Subjects with history of severe uncontrolled diabetes/ cardiopulmonary/hepatobiliary / renal disorders and or malignancy.
- •7.Any acute infection within two weeks prior to enrolment.
- •8.Drug addiction within 3 months prior to enrolment (including alcohol dependence, i.e. more than approx.
- •60 mL of alcohol per day, or conditions which might interfere with the study conduct).
- •9.Pregnancy (positive urine pregnancy test during screening), lactation or unreliable contraception in female subjects after onset of menarche.
- •10.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
结局指标
主要结局
4.Rate of SAEs and medically attended AEs
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period | 3.During the subsequent follow up period up to 28th day after each dose | 4.Until day 56 after the first vaccination | 5.From baseline to day 56 | 6.From baseline to subsequent visits
1.Solicited local and systemic adverse events (AEs)
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period | 3.During the subsequent follow up period up to 28th day after each dose | 4.Until day 56 after the first vaccination | 5.From baseline to day 56 | 6.From baseline to subsequent visits
2.Solicited and unsolicited local and systemic adverse events (AEs)
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period | 3.During the subsequent follow up period up to 28th day after each dose | 4.Until day 56 after the first vaccination | 5.From baseline to day 56 | 6.From baseline to subsequent visits
6.Vital signs (Pulse, axillary/oral body temperature, Blood pressure and Respiratory rate)
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period | 3.During the subsequent follow up period up to 28th day after each dose | 4.Until day 56 after the first vaccination | 5.From baseline to day 56 | 6.From baseline to subsequent visits
3.Solicited and unsolicited adverse events (AEs)
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period | 3.During the subsequent follow up period up to 28th day after each dose | 4.Until day 56 after the first vaccination | 5.From baseline to day 56 | 6.From baseline to subsequent visits
5.All safety laboratory parameters (Haematology & serum chemistry) for any clinically significant changes
时间窗: 1.During first 30 minutes of vaccine administration | 2.During 7-day (Day 0-6) post vaccination period | 3.During the subsequent follow up period up to 28th day after each dose | 4.Until day 56 after the first vaccination | 5.From baseline to day 56 | 6.From baseline to subsequent visits
次要结局
- 1.Number and percentage of subjects seroconverted(2.Proportion of subjects achieving ≥4-fold rise in titre)