An observational study in Covid19, sponsored by Institute of Public Health, Albania. Status unknown at 3 sites in Albania. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by Institute of Public Health, Albania · Observational
The purpose of this study is to evaluate the effectiveness of the COVID-19 vaccine in hospital based HWs in Albania. This will answer critical questions about the real-world performance of COVID-19 vaccines in one of the key target groups for vaccination.
This protocol describes a prospective one-year cohort study of hospital-based health workers in Albania to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID -19 disease.
The investigators will measure the effectiveness of COVID-19 vaccines against laboratory-confirmed SARS-CoV-2 infection in both symptomatic and asymptomatic hospital health workers.
SARS-CoV-2 infection will be diagnosed using symptom questionnaires and PCR testing. Additionally, serology testing will be obtained over the course of one year, to identify asymptomatic infections.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Institute of Public Health, Albania as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study population will be composed of health workers in the above hospitals, eligible for vaccination, with no contraindication to receive COVID-19 vaccine. Health Workers include all categories of staff working in the hospitals, including clinical and non-clinical/administrative staff and staff with direct patient interaction and those without direct patient interaction.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who have received 2 doses of the pfizer Covid-19 vaccine or 1 or dose of the Astra Zeneca Covid-19 Vaccine
Biological: COVID-19 vaccine
Have not received any doses of any form of COVID-19 vaccine
Observation of individuals who receive the COVID-19 vaccine (2 doses of PfizerBioNtech COVID-19 vaccine).
COVID-19 vaccine effectiveness
Data will be collected using weekly symptom questionnaires, COVID-19 PCR confirmation for any symptomatic participant and quarterly serology assessment for all participants to identify N-protein presents to suggest new infection, rather than vaccine induced antibody response.
Time frame: 12 months
COVID-19 PCR confirmation
Data will be collected using weekly symptom questionnaires, COVID-19 PCR confirmation for any symptomatic participant and quarterly serology assessment for all participants to identify N-protein presents to suggest new infection, rather than vaccine induced antibody response.
Time frame: 12 months
Vaccine effectiveness by age
The enrollment questionnaire includes age of each participant. Data will be stratified by age at the time of analysis.
Time frame: 12 months
Vaccine effectiveness by co-morbidities
The enrollment questionnaire will include specific co-morbidities, including (but not limited to) heart disease, autoimmune disease, chronic liver disease and chronic kidney disease. Data will be stratified by co-morbidity at the time of analysis.
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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