ISRCTN28445844已完成不适用
A study comparing the effect of various schedules of the 7-valent licensed CRM197 - conjugated pneumococcal vaccine (Prevnar®) on carriage of Streptococcus pneumoniae in infants and toddlers
Individual Sponsor (Israel)0 个研究点目标入组 730 人开始时间: 2005年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 730
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
- 性别
- All
入选标准
- •Groups A, B, C, D: 2 m +/- 3 weeks
- •Group E: 18 m +/- 1 m
- •2. Males or females
- •3. On time for routine immunization
- •4. For group E: Received previously 4 doses of Diphtheria, Tetanus, Pertussis (DTP), Haemophilus influenzae type b (Hib) and inactivated polio vaccine (IPV)
- •5. The parents and legal guardians must understand and be able, willing and likely to fully comply with the study procedures and restrictions
- •6. The parents and legal guardians must provide written informed consent
- •7. Patient must be healthy during vaccination procedure
排除标准
- •1. Prematurity of less than 35 weeks
- •2. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without a fever. Study vaccines can be administered to persons with a minor illness such as diarrhea or mild upper respiratory infection (URI) without fever (rectal temperature <38.0 °C/100.4 °F).
- •3. Axillary temperature >38.0 °C/100.4 °F prior to any injection
- •4. Any clinically important congenital abnormality, any inherited disorder of the metabolism
- •5. Thrombocytonpenia or any coagulation disorder that would contraindicate intramuscular (im) injection
- •6. Prior receipt of a licensed or investigational pneumococcal vaccine
- •7. Chronic (defined as more than 14 consecutive days) use of immunosuppressants or other immune-modifying drugs. For corticosteroids, this is defined as daily systemic therapy with prednisone or its equivalent at a dose of =2 mg/day.
- •8. Known or suspected allergy to any constituent of either product administered in the study
- •9. Known or suspected intolerance of hypersensitivity, to the study materials (or closely related compounds) or any of the stated ingredients, including diphtheria toxoid and tetanus toxoid
- •10. Hypotonic-hyporesponsive state within 48 hours after a prior dose of any vaccine
- •11. Persistent inconsolable crying lasting =3 hours within 48 hours after a prior dose of any vaccine
- •12. Known to be infected with human immunodeficiency virus (HIV) or mother is HIV positive
- •13. Any other condition or social circumstance (e.g. lack of a telephone, impending relocation) that, in the opinion of the investigator, would make the subject unsuitable or unable to complete the study
研究者
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