A Multi-national, Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Varivax in Healthy Children 12 Months to 12 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 2
- 主要终点
- seroconversion rate by FAMA (Fluorescent Antibody to Membrane Antigen) assay
研究概览
简要总结
This study assesses non-inferiority by comparing seroconversion rate of NBP608 to Varivax which are indicated for active immunization for prevention of varicella. Total of 488 subjects (244 subjects per 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-national, multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to varivax which are indicated for active immunization for the prevention of varicella. Total of 488 subjects 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 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) vaccination 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
研究组 & 干预措施
NBP608
Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
干预措施: NBP608 (Biological)
Varivax
Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm or the anterolateral thigh
干预措施: Varivax (Biological)
结局指标
主要结局
seroconversion rate 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 gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)(6 weeks after IP(Investigational Product) vaccination)
- 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)
- seroconversion rate by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay)(6 weeks after IP(Investigational Product) vaccination)