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临床试验/NCT05113472
NCT05113472已完成不适用

Adverse Reactions Following COVID-19 Vaccination: an Ecuadorian Experience

Respiralab1 个研究点 分布在 1 个国家目标入组 1,291 人开始时间: 2021年3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
Respiralab
入组人数
1,291
试验地点
1
主要终点
Adverse reactions

研究概览

简要总结

Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

详细描述

The COVID-19 pandemic bears a burden on medical care and economies worldwide, however immunization at the population level provides a way for to reduce future morbidity and mortality. Vaccine hesitancy and reluctance in getting the COVID-19 vaccine and apprehensions about them have been present along the course of vaccination programs and mass immunizations across the world. Factors such as the quick, large-scale production of vaccines, lack of information, and uncertainty about adverse reactions in the public's eye as well about myths spreading through media channels have given rise to suspicion and fear in the Latin American population. Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador. The objective of this study was to assess a cohort of Ecuadorian healthcare workers for adverse reactions following vaccination with the Pfizer-BioNTech vaccine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ecuadorian nationality
  • Active practice in the medical field
  • Received the Pfizer-BioNTech COVID-19 vaccine

排除标准

  • Patients who voluntarily refused to participate.

结局指标

主要结局

Adverse reactions

时间窗: 14 days since administration of either dose

Pain, erythema, edema, pruritus, axillary edema, fever, cephalea, malaise, arthralgia, nausea, diarrhea, chills, fatigue, somnolence, syncope, paresthesia, anxiety, dizziness, epigastric pain, generalized rash, generalized pruritus, allergic rhinitis, petechiae, throat itchiness, allergic sinusitis, facial edema, bronchospasm, allergic conjunctivitis, dermatitis, eczema, ocular edema, urticaria, lip swelling, tongue swelling, facial rash, anaphylaxis.

次要结局

未报告次要终点

研究者

发起方
Respiralab
申办方类型
Other
责任方
Sponsor

研究点 (1)

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