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临床试验/ISRCTN78147026
ISRCTN78147026已完成2 期

A phase II, observer-blind, randomised, active controlled study to compare the safety, immunogenicity, and induction of immunological memory of a meningococcal A conjugate vaccine, a meningococcal ACYW polysaccharide vaccine and a hib conjugate vaccine, administered in healthy toddlers 12 - 23 months of age

Serum Institute of India Limited (SIIL)0 个研究点目标入组 600 人开始时间: 2006年9月21日最近更新:
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试验速览

阶段
2 期
状态
已完成
发起方
入组人数
600
研究概览入排标准研究者记录与标识符相似试验

研究概览

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •1. Age 12 to 23 months of age (both included)
  • •2. Written informed consent obtained from the mother, father, or 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. Mother, father, or 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
  • •6. Fully vaccinated according to local Expanded Program on Immunisation (EPI) schedule

排除标准

  • •1. Previous vaccination against serogroup A Neisseria meningitidis
  • •2. Known exposure to serogroup A Neisseria meningitidis during the three previous months
  • •3. History of allergic disease or known hypersensitivity to any component of the three study vaccines
  • •4. History of Serious Adverse Reactions (SAR) following administration of vaccines included in the local program of immunization
  • •5. Administration of any other vaccine within 60 days prior to administration of study vaccines or planned vaccination during the first four weeks after the study vaccination
  • •6. Use of any investigational or non-registered drug within 90 days prior to the administration of study vaccines
  • •7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the vaccine period
  • •8. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone or equivalent, 0.5 mg/kg/day [topical steroids are allowed])
  • •9. A family history of congenital or hereditary immunodeficiency
  • •10. History of meningitis or seizures or any neurological disorder
  • •11. Major congenital defects or serious chronic illness, including malnutrition (as per investigator's judgment)
  • •12. Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever) is a temporary exclusion
  • •13. 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
  • •14. 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
  • •15. Non-residence in the study area or intent to move out within one year

研究者

发起方
Serum Institute of India Limited (SIIL)

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