NCT05254977

Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,515 (actual)
• Sponsor: Islamia University of Bahawalpur · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• COVID-19 Vaccination
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
DRUG	Standard Preparation	Any kind of intervention received to reduce adverse effects

Timeline

• Start date: 2022-02-26
• Primary completion: 2022-03-10
• Completion: 2022-03-30
• First posted: 2022-02-24
• Last updated: 2022-04-13

Locations

1 site across 1 country: Pakistan