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

Islamia University of Bahawalpur1 site in 1 country3,515 target enrollmentFebruary 26, 2022

ConditionsCOVID-19 Vaccination Vaccine Adverse Reaction

InterventionsStandard Preparation

DrugsStandard Preparation

Overview

Phase: Not Applicable
Intervention: Standard Preparation
Conditions: COVID-19 Vaccination
Sponsor: Islamia University of Bahawalpur
Enrollment: 3515
Locations: 1
Primary Endpoint: Allergic reactions and hypersensitivity
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 26, 2022

End Date

March 30, 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Islamia University of Bahawalpur

Responsible Party

Principal Investigator

Hafiz Abdul Sattar Hashmi

Lecturer

Islamia University of Bahawalpur

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

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