Randomized, Double-blinded, Parallel-group, Exploratory Study to Assess The Immunogenicity and Safety of NBP608 and Varivax in Healthy Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Seroconversion rate measured by FAMA(Fluorescent Antibody to Membrane Antigen) assay
研究概览
简要总结
This study evaluates the immunogenicity and safety of three different potencies of NBP608 and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
详细描述
This is a multi-center, randomized, double blinded, active controlled, parallel-group study to evaluate the immunogenicity and safety of three different potencies of NBP608(low, middle, high potency) and Varivax which are indicated for active immunization for the prevention of varicella. Total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1:1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.
Total of four visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 1 and Visit 3 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 2*, Visit 3 and Visit 4* (*telephone contact)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children aged between 12 months and 12 years old who are available for the follow-up during the study period
- •After menarche females who are confirmed to be negative in a pregnancy test on the day of vaccination and agree to practice birth control for 3 months after the vaccination
排除标准
- •Those with hypersensitivity to any component of the IPs(Investigational Products), such as gelatin or neomycin
- •Those who have received a varicella vaccine previously
- •Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
- •Those with congenital or acquired immunodeficiency
- •Those with active untreated tuberculosis
- •Those who have received or are expected to receive salicylates from 14 days prior to IP(Investigational Product) vaccination to Visit 3
- •Those who have received or are expected to receive other vaccines from 1 month prior to IP(Investigational Product) to Visit 3
- •Those who have received or are expected to receive other IPs(Investigational Products) in another clinical study from 1 month prior to IP(Investigational Product) vaccination to Visit 3
结局指标
主要结局
Seroconversion rate measured by FAMA(Fluorescent Antibody to Membrane Antigen) assay
时间窗: 6 weeks after IP(Investigational Product) vaccination
\*FAMA(Fluorescent Antibody to Membrane Antigen) Seroconversion Rate: the rate of subjects who are converted from seronegative with FAMA(Fluorescent Antibody to Membrane Antigen) VZV(Varicella Zoster Virus) antibody titer \< 1:4 before IP(Investigational Product) vaccination to seropositive with FAMA(Fluorescent Antibody to Membrane Antigen) VZV(Varicella Zoster Virus) antibody titer ≥ 1:4 at 6 weeks post-vaccination
次要结局
- VZV (Varicella Zoster Virus) antibody GMT (Geometric Mean Titer) measured by FAMA(Fluorescent Antibody to Membrane Antigen) assay(6 weeks after IP(Investigational Product) vaccination)
- VZV (Varicella Zoster Virus) antibody GMT (Geometric Mean Titer) measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)(6 weeks after IP(Investigational Product) vaccination)
- Seroconversion rate measured by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)(6 weeks after IP(Investigational Product) vaccination)