PACTR201110000328305已完成未知
A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of different schedules and formulations of a meningococcal A conjugate vaccine administered concomitantly with local EPI vaccines in healthy infants and toddlers
Serum Institute of India Ltd (SIIL)0 个研究点目标入组 1,500 人开始时间: 2011年10月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
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
- 年龄范围
- 9 Month(s) 至 18 Month(s)（—）
- 性别
- All
入选标准
- •1. Age 9 months (window 9 to 12 months)
- •2. Written informed consent obtained from parent(s) or guardian(s) of the child
- •3. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
- •4. Parent(s) or guardian(s) 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
- •6. Fully vaccinated according to the local EPI schedule (1 dose of BCG, 3 doses of DTwPHibHep and 4 doses of OPV)
排除标准
- •1.Previous vaccination against Neisseria meningitidis
- •2. Known exposure to Neisseria meningitidis during the three previous months
- •3. 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 immunization
- •4. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination in the 28 days following the study vaccination
- •5. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
- •6. Administration of immunoglobulins and/or any blood products within 90 days prior to the administration of study vaccines or planned administration during the vaccine period
- •7. 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, ¿ 0.5 mg/kg/day; topical steroids including inhaled steroids are allowed.)
- •8. A family history of congenital or hereditary immunodeficiency
- •9. History of meningitis or seizures or any neurological disorder
- •10. 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 objectives
- •13. 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 study
- •14. Non residence in the study area or intent to move out within 10 months
研究者
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