Post Vaccination Adverse Events in Covid-19 Vaccine Recipients

NCT05254977 | Completed DMC

• 1 other identifier: UCCM/2022/Covid-19/01
• Study Type: observational
• Target: 3,515
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Vaccination; Vaccine Adverse Reaction

Keywords

Covid-19 Vaccination, Inactivated Vaccine, RNA vaccine

Outcome Measures

Primary Outcomes (6)

• Allergic reactions and hypersensitivity

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

  1st January 2021 to 31st December 2021

• Cardiovascular Diseases

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

  1st January 2021 to 31st December 2021

• Respiratory disorders and Respiratory hypersensitivity

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

  1st January 2021 to 31st December 2021

• Urologic Diseases

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

  1st January 2021 to 31st December 2021

• Immune system disorders

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

  1st January 2021 to 31st December 2021

• Musculoskeletal diseases

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

  1st January 2021 to 31st December 2021

Study Arms (28)

B.V. HOSPITAL

Local population in surrounding premises of site

Drug: Standard Preparation

Baldia Hall Yazman

Local population in surrounding premises of site

Drug: Standard Preparation

CIVIL HOSPITAL Bahahwalpur

Local population in surrounding premises of site

Drug: Standard Preparation

DDHO KPT

Local population in surrounding premises of site

Drug: Standard Preparation

Govt Girls Elementry School

Local population in surrounding premises of site

Drug: Standard Preparation

Govt Higher Secondary School

Local population in surrounding premises of site

Drug: Standard Preparation

Govt Sadiq Higher Secondary School

Local population in surrounding premises of site

Drug: Standard Preparation

Govt TibIA College Bahawalpur

Local population in surrounding premises of site

Drug: Standard Preparation

CEO Office DHA BWP

Local population in surrounding premises of site

Drug: Standard Preparation

Papulation Welfare office APE

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Ballah Jhulan

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Channi Goth

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Choona wala

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Dera Bakha

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Headrajkan

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Khanqah sharif

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Khutri Banglow

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Kud Wala

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Lal Sohanra

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Mubarkpur

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Qaimpur

Local population in surrounding premises of site

Drug: Standard Preparation

RHC Uch Sharif

Local population in surrounding premises of site

Drug: Standard Preparation

Special Education Degree Colage

Local population in surrounding premises of site

Drug: Standard Preparation

THQ HOSPITAL, AHMADPUR

Local population in surrounding premises of site

Drug: Standard Preparation

THQ HOSPITAL, HASILPUR.

Local population in surrounding premises of site

Drug: Standard Preparation

THQ KHAIR PUR TAMEWALI

Local population in surrounding premises of site

Drug: Standard Preparation

THQ YAZMAN

Local population in surrounding premises of site

Drug: Standard Preparation

TMA Office Hasilpur (NEW)

Local population in surrounding premises of site

Drug: Standard Preparation

Interventions

Standard Preparation DRUG

Any kind of intervention received to reduce adverse effects

B.V. HOSPITAL; Baldia Hall Yazman; CEO Office DHA BWP; CIVIL HOSPITAL Bahahwalpur; DDHO KPT; Govt Girls Elementry School; Govt Higher Secondary School; Govt Sadiq Higher Secondary School; Govt TibIA College Bahawalpur; Papulation Welfare office APE; RHC Ballah Jhulan; RHC Channi Goth; RHC Choona wala; RHC Dera Bakha; RHC Headrajkan; RHC Khanqah sharif; RHC Khutri Banglow; RHC Kud Wala; RHC Lal Sohanra; RHC Mubarkpur; RHC Qaimpur; RHC Uch Sharif; Special Education Degree Colage; THQ HOSPITAL, AHMADPUR; THQ HOSPITAL, HASILPUR.; THQ KHAIR PUR TAMEWALI; THQ YAZMAN; TMA Office Hasilpur (NEW)

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General population above age of 12 years will be eligible to collection information on adverse effects of SARS-Cov-2 vaccination

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Islamia University of Bahawalpur: lead
• District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.: collaborator

Study Sites (1)

University College of Conventional Medicine

Bahawalpur, Punajb, 63100, Pakistan

Location

MeSH Terms

Interventions

Reference Standards

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Hafiz Abdul Sattar, M.Phil

  Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: February 24, 2022
• Study Start: February 26, 2022
• Primary Completion: March 10, 2022
• Study Completion: March 30, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)