Data Collection for Post Vaccination Adverse Events in Covid-19 Vaccine Recipients in District Bahawalpur A Multi-center Observational Study
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
- 是
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
Hafiz Abdul Sattar Hashmi
Lecturer
Islamia University of Bahawalpur
