COVID-19 VaccinationNCT05254977
Post Vaccination Adverse Events in Covid-19 Vaccine Recipients
An observational study of COVID-19 Vaccination and Vaccine Adverse Reaction, run by Islamia University of Bahawalpur at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccination, Vaccine Adverse Reaction
- What is being tested?
- Standard Preparation
- How many people
- 3,515 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Feb 2022to 30 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: General population above age of 12 years will be eligible to collection information on adverse effects of SARS-Cov-2 vaccination
Who may be able to join
- 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
Who cannot join
- Age <12 years of age Not vaccinated History of disease before vaccination
- -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University College of Conventional Medicine
Bahawalpur, Punajb, 63100
About this study
Official title: Data Collection for Post Vaccination Adverse Events in Covid-19 Vaccine Recipients in District Bahawalpur A Multi-center Observational Study
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.
Read the 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
- Being tested
- Standard Preparation
- Keywords
- Covid-19 Vaccination, Inactivated Vaccine, RNA vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PreparationDrug
Any kind of intervention received to reduce adverse effects
| Study group | Role | What they receive |
|---|---|---|
| B.V. HOSPITAL | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| Baldia Hall Yazman | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| CIVIL HOSPITAL Bahahwalpur | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| DDHO KPT | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| Govt Girls Elementry School | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| Govt Higher Secondary School | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| Govt Sadiq Higher Secondary School | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| Govt TibIA College Bahawalpur | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| CEO Office DHA BWP | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| Papulation Welfare office APE | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Ballah Jhulan | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Channi Goth | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Choona wala | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Dera Bakha | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Headrajkan | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Khanqah sharif | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Khutri Banglow | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Kud Wala | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Lal Sohanra | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Mubarkpur | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Qaimpur | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| RHC Uch Sharif | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| Special Education Degree Colage | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| THQ HOSPITAL, AHMADPUR | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| THQ HOSPITAL, HASILPUR. | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| THQ KHAIR PUR TAMEWALI | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| THQ YAZMAN | Local population in surrounding premises of site Receives: Drug: Standard Preparation | |
| TMA Office Hasilpur (NEW) | Local population in surrounding premises of site Receives: Drug: Standard Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergic reactions and hypersensitivity
Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease
Measured: 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
Measured: 1st January 2021 to 31st December 2021
Respiratory disorders and Respiratory hypersensitivity
Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease
Measured: 1st January 2021 to 31st December 2021
Urologic Diseases
Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease
Measured: 1st January 2021 to 31st December 2021
Immune system disorders
Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease
Measured: 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
Measured: 1st January 2021 to 31st December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start26 Feb 2022
- Primary completion10 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 3,515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Collaborators
- District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.
- Responsible party
- Principal investigator, Hafiz Abdul Sattar Hashmi, Islamia University of Bahawalpur
- Investigators
- Hafiz Abdul Sattar, M.Phil, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254977
- Sponsor's protocol ID
- UCCM/2022/Covid-19/01
- Status last verified
- Apr 2022
- First submitted
- 19 Feb 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection for Post Vaccination Adverse Events in Covid-19 Vaccine Recipients in District Bahawalpur A Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT05254977
- Acronym / sponsor ID
- UCCM/2022/Covid-19/01
- Conditions
- COVID-19 Vaccination, Vaccine Adverse Reaction
- Keywords
- Covid-19 Vaccination, Inactivated Vaccine, RNA vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,515 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Collaborators
- District Health Authority (DHA) Bahawalpur District Bahawalpur, Government of Punjab.
- Study start
- 26 Feb 2022 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 28
| Arm | Type | Receives |
|---|---|---|
| B.V. HOSPITAL | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| Baldia Hall Yazman | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| CIVIL HOSPITAL Bahahwalpur | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| DDHO KPT | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| Govt Girls Elementry School | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| Govt Higher Secondary School | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| Govt Sadiq Higher Secondary School | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| Govt TibIA College Bahawalpur | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| CEO Office DHA BWP | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| Papulation Welfare office APE | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Ballah Jhulan | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Channi Goth | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Choona wala | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Dera Bakha | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Headrajkan | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Khanqah sharif | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Khutri Banglow | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Kud Wala | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Lal Sohanra | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Mubarkpur | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Qaimpur | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| RHC Uch Sharif | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| Special Education Degree Colage | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| THQ HOSPITAL, AHMADPUR | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| THQ HOSPITAL, HASILPUR. | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| THQ KHAIR PUR TAMEWALI | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| THQ YAZMAN | – | Drug: Standard PreparationLocal population in surrounding premises of site |
| TMA Office Hasilpur (NEW) | – | Drug: Standard PreparationLocal population in surrounding premises of site |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population above age of 12 years will be eligible to collection information on adverse effects of SARS-Cov-2 vaccination
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Age <12 years of age Not vaccinated History of disease before vaccination
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard PreparationAny kind of intervention received to reduce adverse effects | Drug | 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) |
Primary outcome
Allergic reactions and hypersensitivity
Time frame: 1st January 2021 to 31st December 2021
Questionnaire for Allergic reaction at injection site or generalized allergic responses excluding previously known disease
Cardiovascular Diseases
Time frame: 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
Time frame: 1st January 2021 to 31st December 2021
Questionnaire for Cough, dyspnea, Tachypnea, Asthma, Rhinitis, excluding previously known disease
Urologic Diseases
Time frame: 1st January 2021 to 31st December 2021
Questionnaire for Kidney diseases, Urinary tract infection, Urolithiasis excluding previously known disease
Immune system disorders
Time frame: 1st January 2021 to 31st December 2021
Questionnaire for Autoimmune diseases, Erythroblastosis, Glomerulonephritis, thrombocytopenia, Autoimmune Lymphoproliferative Syndrome excluding previously known disease
Musculoskeletal diseases
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafiz Abdul Sattar, M.Phil principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Vaccination and Vaccine Adverse Reaction, run by Islamia University of Bahawalpur at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergic reactions and hypersensitivity (time frame: 1st January 2021 to 31st December 2021). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.