NCT01362517已完成3 期
Assessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae Among Healthy Vietnamese Children
Crucell Holland BV1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
研究概览
简要总结
The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Days 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems
- •Have a normal gestational age (≥ 37 weeks); birth weight > 2.5 kg
- •There is no congenital disease detected through interview and clinical examination
- •Already had or not yet received Hepatitis B vaccination at birth
- •Do not have dermatological diseases such as eczema, allergies
- •Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures
排除标准
- •Already vaccinated with DTP vaccine
- •Have an acute infection at the time of study vaccination
- •Contraindications to Quinvaxem
- •Receiving treatment with systemic corticosteroids
- •Currently participating in another clinical trial
- •In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth
- •Parents intend to move to another location during the study (the next 12 months)
结局指标
主要结局
Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component
时间窗: at 14 months (equivalent to 12 months after the first vaccination
Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)
次要结局
- Safety: Adverse and Serious Adverse Events(From Day 1 up to 30 days after the third vaccination)
研究者
研究点 (1)
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