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临床试验/NCT05254977
NCT05254977已完成不适用

Data Collection for Post Vaccination Adverse Events in Covid-19 Vaccine Recipients in District Bahawalpur A Multi-center Observational Study

Islamia University of Bahawalpur1 个研究点 分布在 1 个国家目标入组 3,515 人开始时间: 2022年2月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,515
试验地点
1
主要终点
Allergic reactions and hypersensitivity

研究概览

简要总结

Covid-19 pandemic is caused by Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-Cov-2) since its outbreak 2019. Protection against Covid-19 can be achieved through global immunization. Various vaccines for SARS-Cov-2 has been registered and approved for administration in humans. It is important to understand the safety and efficacy of vaccines during robust research to develop global immunity against SARS-Cov-2. This study aimed to collect data on post vaccination adverse events in regional population of District Bahawalpur.

详细描述

Bahawalpur District of Punjab province has population of 3.998 million and among these 2.6 million above 12 years of age are eligible for vaccination against SARS-Cov-2. 28 centers were established for vaccination within the districts at designated sites for Covid-19 vaccination. 87% targeted population has been vaccinated till 15th February 2022. Investigators designed this study to collect and evaluate data on adverse effects after vaccination of Covid-19. Investigators aimed to collect information through interviewing participants in general places of designated sites of vaccination centers established in District Bahawalpur. History will be recorded from participants and in case of adverse events detailed available history will be recorded including following adverse effects from available records on following.

  • Cardiovascular adverse effects
  • Cerebrospinal adverse events
  • Respiratory disturbances
  • Hepatobiliary disorders
  • Urogenital adverse effects
  • Musculoskeletal adverse effect
  • Psychological diseases
  • Blood biomarkers changes
  • Autoimmune adverse events
  • Allergic reactions and hypersensitivity Collected data will be summarized to get percentage of adverse effects in general population. Recorded adverse events will be assessed for their frequency in participants and association with vaccination will be assessed through employing statistical methods. Subsequent information on handling of adverse events will be recorded including
  • Nature of adverse event
  • Hospitalization and severity of adverse events
  • Mortality / morbidity caused by vaccination
  • Days of hospitalization
  • Changes in Blood biomarkers
  • Interventions adopted for adverse events
  • Diseased period
  • Covid-19 infection positivity through RT-PCR / imaging for round glass opacities / Covid-19 changes Overall efficacy and safety of vaccination will be assessed through collected data.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >12 year Vaccinated (Single Dose, Double Dose, Booster Dose) Clinical diagnosis of Allergic reactions and hypersentivity, Cardiovascular diseases Musculoskeletal diseases Respiratory disease Immunological disease Kidney diseases

排除标准

  • Age <12 years of age Not vaccinated History of disease before vaccination

研究组 & 干预措施

CIVIL HOSPITAL Bahahwalpur

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

DDHO KPT

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

Govt Girls Elementry School

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

Govt Higher Secondary School

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

Baldia Hall Yazman

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

B.V. HOSPITAL

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

Govt Sadiq Higher Secondary School

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

Govt TibIA College Bahawalpur

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

CEO Office DHA BWP

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

Papulation Welfare office APE

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Ballah Jhulan

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Channi Goth

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Choona wala

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Dera Bakha

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Headrajkan

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Khanqah sharif

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Khutri Banglow

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Kud Wala

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Lal Sohanra

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Mubarkpur

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Qaimpur

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

RHC Uch Sharif

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

Special Education Degree Colage

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

THQ HOSPITAL, AHMADPUR

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

THQ HOSPITAL, HASILPUR.

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

THQ KHAIR PUR TAMEWALI

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

THQ YAZMAN

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

TMA Office Hasilpur (NEW)

Local population in surrounding premises of site

干预措施: Standard Preparation (Drug)

结局指标

主要结局

Allergic reactions and hypersensitivity

时间窗: 1st January 2021 to 31st December 2021

Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease

Cardiovascular Diseases

时间窗: 1st January 2021 to 31st December 2021

Questionnaire for Post Vaccination adverse development of Hypertension, heart diseases, vascular diseases excluding previously known disease

Respiratory disorders and Respiratory hypersensitivity

时间窗: 1st January 2021 to 31st December 2021

Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease

Urologic Diseases

时间窗: 1st January 2021 to 31st December 2021

Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease

Immune system disorders

时间窗: 1st January 2021 to 31st December 2021

Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease

Musculoskeletal diseases

时间窗: 1st January 2021 to 31st December 2021

Questionnaire for fatigue syndrome, muscle weakness, muscle spasticity, muscle rigidity, Musculoskeletal pain, myalgia, osteoarthritis, Myositis excluding previously known disease

次要结局

未报告次要终点

研究者

发起方
Islamia University of Bahawalpur
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hafiz Abdul Sattar Hashmi

Lecturer

Islamia University of Bahawalpur

研究点 (1)

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