NCT02146469Unknown4 期
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Shanghai Municipal Center for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Seroconversion rate and GMCs after varicella vaccination
研究概览
简要总结
The objective of the study is as follows:
- To know the antibody level during different interval after received 1 dose varicella vaccine.
- To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
- To know safety and effectiveness of received varicella vaccine and MMR at the same time.
To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.
All blood specimens will be tested by a third-party detection institution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 1 to 7
- •Without a previous history of varicella
- •With an axillary temperature ≤37.5℃ at the time of vaccination
- •Appropriate varicella vaccination history
- •With guardian signing the informed consent and available for clinical observation
排除标准
- •Hypersensitive to any active substance of the vaccine including excipients and antibiotics
- •With acute illness, severe or acute attack of chronic illness or fever
- •With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs
- •Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease
- •With a family or personal history of seizure, chronic illness, epilepsy or allergy
- •With unknown immunization history or unable to follow the immunization schedule of EPI
- •Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month
- •With hemorrhagic tendency or prolonged period of bleeding
- •Received whole blood, plasma or immunoglobulin within 5 months
- •Received systemic antibiotics or antiviral treatment for acute illness within 7 days
- •With an axillary temperature ≥38℃ within 3 days
- •Participating in another clinical trial
- •Any situation that might influence the consequence of the clinical trial
结局指标
主要结局
Seroconversion rate and GMCs after varicella vaccination
时间窗: 35-42 days after each dose vaccination
次要结局
- The incidence of Adverse Events Following Immunization(30 days after each dose vaccination)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Evaluation of the Efficacy of the Live Attenuated Tetravalent Dengue Vaccine Against DENV-2 and DENV-3 ChallengeDengueNCT03416036National Institute of Allergy and Infectious Diseases (NIAID)64
Unknown
2 期
Profiling Antibody Status and Vaccine Effectiveness in Post Vaccination With SARS CoV2 in Ain Shams UniversityCovid19NCT04885764Ain Shams University4,000
已完成
3 期
Study Evaluating Persistence Of Antibody Response Elicited By 13vPnC In Healthy Adults Previously VaccinatedHealthyNCT01025336Pfizer962
已完成
2 期
Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy ParticipantsDengue FeverNCT02302066Takeda1,800
已完成
2 期
Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic FeverHemorrhagic Fever With Renal SyndromeNCT02116205U.S. Army Medical Research and Development Command130