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临床试验/ISRCTN82484612
ISRCTN82484612已完成2 期

A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infants

Serum Institute of India Limited0 个研究点目标入组 1,200 人开始时间: 2008年8月6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
1,200
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. Aged 14 to 18 weeks old
  • •2. Free of obvious health problems as established by medical history including physical examination and clinical judgment of the investigator
  • •3. Guardian capable and willing to bring their child or to receive home visits for their child for all follow-up visits
  • •4. Residence in the study area
  • •5. Fully vaccinated according to the local EPI schedule (Bacillus Calmette-Guerin [BCG] and OPV at birth, two doses of diphtheria, tetanus, whole cell pertussis, haemophilus influenzae type B and hepatitis B virus [DTwPHibHBV] and OPV at 6 and 10 weeks of age)

排除标准

  • •1. Previous vaccination against serogroup A Neisseria meningitidis
  • •2. Known exposure to serogroup A N. meningitidis since birth
  • •3. History of allergic disease or known hypersensitivity to any component of the study vaccines
  • •4. History of serious adverse reactions following administration of vaccines included in the local program of immunisation
  • •5. Administration of any vaccine other than EPI vaccines within 30 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 since birth
  • •7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
  • •8. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying agents since birth (including systemic or inhaled corticosteroids, this means prednisone, or equivalent, greater than 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). Minimum weight should be of 4 kg at the time of enrolment in the study (at 14 - 18 weeks of age).
  • •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 2 years

研究者

发起方
Serum Institute of India Limited

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