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临床试验/ISRCTN72821613
ISRCTN72821613进行中(未招募)4 期

The effect of a two-dose compared to a three-dose schedule of pneumococcal conjugate vaccine on pneumococcal acquisition, immunogenicity, and co-administration of pneumococcal conjugate and yellow fever vaccines

ondon School of Hygiene & Tropical Medicine0 个研究点目标入组 827 人开始时间: 2019年11月28日最近更新:
适应症

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
827

研究概览

简要总结

2022 Protocol article in https://doi.org/10.1186/s13063-021-05949-4 (added 24/05/2022)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Resident in the study area (PVS-AcqImm trial)
  • 2. Age 0-6 weeks
  • 3. Intention to reside in cluster until 18 months of age

排除标准

  • 1. Intent to move out of the study area before 18 months of age
  • 2. Age greater than 6 weeks
  • 3. Prematurity <34 weeks gestation
  • 4. Birth weight <2.0kg or weight <2.5 kg
  • 5. History of invasive bacterial infection or measles
  • 6. Receiving long-term antibiotic therapy, defined as greater than 4 weeks
  • 7. HIV infection in the infant or mother
  • 8. Chronic debilitating illness
  • 9. Immunosuppressive therapy or immunodeficiency disorder
  • 10. Contraindication to PCV13 – severe hypersensitivity to a previous dose of PCV13
  • 11. Contraindication to YF vaccine

研究者

发起方
ondon School of Hygiene & Tropical Medicine

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