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临床试验/PER-015-21
PER-015-21进行中(未招募)3 期

Randomized, double-blind, phase III clinical study to evaluate the immunogenicity of an influenza vaccine with adjuvant in health personnel (EDUCATE)

PERUVIAN CLINICAL RESEARCH S.A.C.0 个研究点目标入组 274 人开始时间: 2021年12月10日最近更新:
适应症

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
274

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

  • - Have participated in the health personnel cohort study between 2016 and 2021
  • - Be of legal age = 18 years
  • - Work at the facility full time (=30 hours per week)
  • - Have routine, direct, practical or face-to-face contact with patients (within 1 meter) as part of a typical work shift, including but not limited to doctors, nurses, respiratory therapists, physiotherapists, unit employees, X-ray technicians, medical assistants, and transporters
  • - Work at the facility for = 1 year prior to enrollment and plan to continue working at the facility for one year after enrollment
  • - Willing to receive the influenza vaccine (AD / SD)
  • - Female participants must meet the following criteria:
  • Negative urine pregnancy test, performed by study staff within 24 hours prior to vaccination.
  • Be willing to use an effective form of contraception, provided by the Investigator (eg oral or injectable contraceptive), for at least two months after receiving the vaccine. If you are not using, we will facilitate access to contraceptives.
  • Not be breastfeeding

排除标准

  • -Be vaccinated against influenza in the current season (20212influenza season or season)
  • - You have severe and life-threatening allergies to influenza vaccines, eggs, or components of the influenza vaccine.
  • - You have a history of Guillain-Barre Syndrome or other autoimmune diseases.
  • - Have received blood or blood products within the 3 months prior to enrollment.
  • - Being pregnant, confirmed by urine test.

研究者

发起方
PERUVIAN CLINICAL RESEARCH S.A.C.

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