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临床试验/ISRCTN87739946
ISRCTN87739946已完成2 期

A phase II/III, observer-blind, randomised, active controlled study to compare the safety and immunogenicity of a meningococcal A conjugate vaccine (PsA-TT) with meningococcal ACWY polysaccharide vaccine administered in healthy subjects 2 to 29 years of age

Serum Institute of India Limited (SIIL)0 个研究点目标入组 900 人开始时间: 2007年8月14日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
900
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

  • •A subject will be eligible for inclusion if ALL of the following apply at the time of enrolment:
  • •1. Age 2 to 29 years of age (both included)
  • •2. Written informed consent obtained from the subject (for subjects equal to 18 years of age)/parents or legal guardian (for subjects less than 18 years of age)
  • •3. Written informed assent from the subject if and as appropriate within the participating community (e.g., for subjects equal to 13 years of age in the Malian site, for subjects equal to 15 years of age in the Senegal site or for subjects equal to 12 years of age in the Gambia site)
  • •4. Free of obvious health problems as established by medical history including physical examination and clinical judgement of the investigator
  • •5. Subject/parents, or legal guardian capable and willing to come/bring their child or to receive home visits for all follow-up visits
  • •6. Residence in the study area
  • •7. Fully vaccinated according to the local Expanded Program on Immunisation (EPI) schedule (for subjects 2 to 3 years of age only)

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 meningitidis during the six previous years
  • •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 immunisation
  • •4. 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 vaccines
  • •6. Administration of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines or planned administration during the study period
  • •7. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to the administration of study vaccines (Including systemic corticosteroids, this means prednisone, or equivalent, greater than 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, including malnutrition (as per investigator's judgement)
  • •11. 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
  • •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 one year
  • •15. Pregnancy or lactation (a negative pregnancy test will be required before vaccination for all women of childbearing potential)
  • •16. Previous inclusion of five family members in the study (i.e., subjects belonging to the same family - biological father, mother, child, and brothers and sisters may be included up to a maximum of five members from the same family)

研究者

发起方
Serum Institute of India Limited (SIIL)

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