Evaluation of Immunogenicity, safety and breakthrough infection of 2-doses of Live Attenuated Varicella Vaccine in Indian Children: 12 months follow up study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- 1. Assessment of immunogenicity of two doses of the vaccine by estimation of seroprotection rates, considering a cut-off of 5gpELISA or 10 mIU/ml of anti-Varicella (VZV) IgG antibody and the rise of geometric mean titer (GMT) from baseline values to four weeks after the 1st and 2nd dose vaccination respectively.
研究概览
简要总结
Varicella is a highly infectious disease caused by the Varicella zoster virus (VZV). Secondary attack rates for this virus might reach 90% for susceptible household contacts. VZV causes a systemic infection that results typically in lifetime immunity. In otherwise healthy persons, clinical illness after re-exposure is rare.
Overall Study design & Plan: The study will be an Open level single arm study to evaluate the immunogenicity & safety of double dose live attenuated varicella Vaccine in healthy Indian children.
This investigator-initiated trial proposes to evaluate the immunogenicity, safety and to estimate the incidence of "Breakthrough" infections of varicella occurring post vaccination with two dose schedule with three months interval. Since there is paucity of published data from India in this field, the long term objectives of the study will be to evaluate the incidence of breakthrough infection and the trend of antibody titre upto 12 months post-vaccination.
Total Population- 305 healthy children in the age group ≥ 12 months but ≤12 years. Each enrolled subject shall be followed up to 12 months post vaccination
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 12.00 Month(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects aged ≥ 12 months but ≤12 years of either sex.
- •2.No clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
- •3.With an axillary temperature ≤37.5°C at the time of vaccination 4.No varicella vaccination history previously.
- •5.Parent or the legal guardian of the subject should provide written informed consent.
- •6.Parent or the legal guardian of the subject should agree to comply with all trial related instructions (maintain diary card, attend follow up visits).
排除标准
- •1.Clinical history of varicella (chicken pox) and herpes zoster natural infection in the past.
- •2.History of household, playmate, school or daycare center exposure to varicella or herpes zoster in the previous 4 weeks prior to vaccination.
- •3.Presence of any person in close vicinity of the subject who is at high risk of developing varicella (like immunocompromised sibling) 4.Any established or clinically suspected immunosuppressive or immunocompromised disorder / state (congenital or acquired- drug induced, neoplastic, tuberculosis etc.) 5.Any subject who had received parenteral immunoglobulin or any immunosuppressive drugs in the last three months.
- •6.Any major congenital abnormality – cardiac, renal, neurological.
- •7.Any acute dermatological disease such as, allergy and bacterial/viral/ fungal infection.
- •8.History of encephalopathy, epilepsy and other nervous system disorders.
- •9.Participant on any dose of oral/parenteral steroids or inhalational steroids >800 mcg of beclomethasone (or its equivalent) in the last 3 months prior to vaccination.
- •10.History of any allergic diatheses and those with known hypersensitivity to vaccine or any of its components like gelatin, gentamicin / neomycin/ kanamycin etc.
- •11.Febrile (axillary temperature > 37.5°C) or any systemic illness at the time of vaccination.
- •12.History of administration of Varicella zoster immune globulin or any blood products in the previous 4 weeks.
- •13.Subject has received any live vaccine in the last 4 weeks or any killed vaccine in the last 4 weeks prior to this scheduled vaccination.
- •14.Subject scheduled to be administered a live vaccine in the next 4 weeks or any killed vaccine in the next 4 weeks.
- •15.Participation in any other interventional clinical trial.
- •16.Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine.
结局指标
主要结局
1. Assessment of immunogenicity of two doses of the vaccine by estimation of seroprotection rates, considering a cut-off of 5gpELISA or 10 mIU/ml of anti-Varicella (VZV) IgG antibody and the rise of geometric mean titer (GMT) from baseline values to four weeks after the 1st and 2nd dose vaccination respectively.
时间窗: Each enrolled subject shall be followed up to 12 months post vaccination.
次要结局
- 1. Incidence of "Breakthrough" infections of varicella occurring post vaccination (from 42 days after 1st and 2nd dose of vaccine to study end i.e. up to 12 months).(2. Assessment of safety by monitoring for solicited and unsolicited vaccine related serious and non-serious adverse effects from first dose vaccination to 6 weeks of second dose post vaccination.)