NCT00734565已完成1 期
A Phase I, Single-arm, Single-center Study to Investigate Safety and Reactogenicity of Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b in Healthy Children Aged 16 - 20 Months and Infants Aged 2 - 4 Months
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年7月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.
研究概览
简要总结
This study will investigate safety and reactogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children
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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 20 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants of either sex, aged 16 - 20 months / 2 - 4 months
- •in good health as determined by: medical history physical examination clinical judgment of the investigator;
- •available for all visits scheduled in the study and able to comply with all study regulations;
- •written informed consent obtained, from at least one parent or legal guardian
排除标准
- •parent or legal guardian is unwilling or unable to give written informed consent to participate in study;
- •infants who presented a previous disease potentially related to Haemophilus influenzae type b;
- •infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease;
- •infants who have received any other Haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already);
- •premature (before 37th week of gestation) or birth weight less than 2500 g;
- •history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
- •fever ≥38.0 °C (axillary body temperature) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
- •subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease;
- •known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
- •subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder;
- •subjects with a clinically significant genetic anomaly;
- •treatment with corticosteroids or other immunosuppressive drugs;
- •treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months);
- •any vaccination administered within 2 weeks (14 days) before enrollment;
- •participation in any other investigational trial simultaneously;
- •planned surgery during the study period;
- •any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective
结局指标
主要结局
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after first vaccination dose will be evaluated.
时间窗: 30 days
次要结局
- Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after second vaccination dose will be evaluated.(90 days)
研究者
研究点 (1)
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