NCT00808392已完成3 期
A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart
Novartis Vaccines2 个研究点 分布在 1 个国家目标入组 916 人开始时间: 2008年11月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 916
- 试验地点
- 2
- 主要终点
- Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).
研究概览
简要总结
This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants of either sex, aged 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
- •For whom written informed consent has been 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 have received any other Haemophilus influenzae type b immunization dose before
- •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
- •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) or/and 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
- •Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
- •Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
- •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
Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).
时间窗: 90 days
次要结局
- Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.(90 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Safety and Reactogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type bHaemophilus Influenzae Type bNCT00734565Novartis Vaccines40
已完成
3 期
Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult VolunteersInfluenzaNCT01987011Green Cross Corporation420
尚未招募
3 期
Clinical Trial of Freeze-dried Human Rabies Vaccine (Without Serum Vero Cells)RabiesNCT05969626Ningbo Rongan Biological Pharmaceutical Co., Ltd.2,460
已完成
3 期
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy ChildrenHaemophilus Influenzae Type b (Hib) InfectionNCT01125527Novartis Vaccines700
已完成
3 期
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE AttacksHereditary AngioedemaNCT01188564Pharming Technologies B.V.75