CTRI/2009/091/000368已完成3 期
A phase III, double-blind, randomized, active controlled study to evaluate the safety and consistency of immunogenicity of three consecutive lots of a Meningococcal A Conjugate Vaccine administered as a single dose to healthy children at 5-10 years of age.
Serum Institute of India Limited0 个研究点目标入组 830 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 830
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age 5 to 10 years of age (both included)
- •2.Written informed consent obtained from parents or legal guardian of the child
- •3.Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
- •4.Parents or legal guardian capable and willing to bring their child or to receive home visits (for their child) for all follow-up visits
- •5.Residence in the study area
排除标准
- •Subjects with any of the following criteria at study entry will not be eligible for participation:1.Previous vaccination against Neisseria meningitidis2.Known exposure to Neisseria meningitidis during the three previous months3.History of allergic disease or known hypersensitivity to any component of the two study vaccines and/or following administration of vaccines included in the local program of immunization4.Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first 28 days after the study vaccination 5.Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines6.Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the vaccine period7.Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic corticosteroids, this means prednisone, or equivalent, ³ 0.5 mg/kg/day; topical steroids including inhaled steroids are allowed.)8.A family history of congenital or hereditary immunodeficiency9.History of meningitis or seizures or any neurological disorder10.Major congenital defects or serious chronic illness (as per investigator?s judgment)11.Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion.12.Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination or laboratory tests, which in the opinion of the investigator, might interfere with the study objectives13.Any condition or criteria that in the opinion of the investigator might compromise the well being of the subject or the compliance with study procedures or interfere with the outcome of the study14.Non residence in the study area or intent to move out within 3 months
研究者
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