Observational National Vaccine Study

Study Overview
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Brief Summary
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To assess the long-term safety of TURKOVAC in individuals who have not previously received the COVID-19 vaccine or who have received their primary vaccination with inactivated or mRNA vaccine, or who have received their primary vaccination with similarly inactivated or mRNA vaccine and who subsequently received the first dose or second dose of booster vaccine, who meet the inclusion/exclusion criteria of the study.

Detailed Description
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The primary objective of the study was to evaluate the long-term safety of TURKOVAC in individuals who had never received a COVID-19 vaccine before, or who received their primary vaccination with inactivated or mRNA vaccine, or who received their primary vaccination with similarly inactivated or mRNA vaccine, and who subsequently received a first dose or second dose of booster vaccine, in individuals who met the inclusion/exclusion criteria of the study. The secondary objective of the study was to evaluate the immunogenicity of TURKOVAC in individuals who meet the inclusion/exclusion criteria of the study.

Official Title
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Observational Study to Evaluate the Effectiveness, Immunogenicity and Safety of Inactivated COVID-19 Vaccine (TURKOVAC) Application

Conditions
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COVID-19 Infection

Intervention / Treatment
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* Biological: Taking biological samples (blood) and keeping records with phone calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who meet all of the following criteria will be included in the study: Individuals aged 18 and over, Individuals who have never had a COVID-19 vaccine before OR who have received COVID-19 mRNA or inactivated vaccines in the primary vaccination and have selected TURKOVAC as the booster dose (3rd dose and 4th dose), Individuals who have not had COVID-19 during the last trimester, Only for subjects who will receive 4th dose of vaccine: Those who have received the third dose of TURKOVAC vaccine and those who have spent at least 90 days since the third dose, Individuals who agree to provide blood samples and verifiable identification information (in accordance with local regulations), who may be contacted by the investigator during the study and who may come into contact with the investigator, Individuals who will be able to voluntarily understand and sign informed consent, Individuals who accept phone calls to be made to them for the purpose of collecting safety-related data. Exclusion Criteria: Subjects who meet one of the following criteria will be excluded from the study. For subjects who will receive primary vaccination: Individuals who have received any vaccine and/or flu vaccine within 14 days prior to the COVID-19 vaccine. Individuals who have chosen a vaccine other than TURKOVAC as a booster dose.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals who have never been vaccinated against COVID-19<br>Individuals who have never been vaccinated against COVID-19 and who have applied to the study centers to be vaccinated with TURKOVAC within the scope of the routine vaccination program. | Biological: Taking biological samples (blood) and keeping records with phone calls<br>* Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.<br>|
| Previously primary vaccinated individuals<br>Those who have previously received two doses of Sinovac - Coronavac vaccine, who will receive the booster vaccine for the first time as TURKOVAC; Those who have previously received two doses of the BioNTech Comirnaty vaccine, who will receive the booster vaccine for the first time as TURKOVAC; Those who have previously received the primary vaccination of Sinovac - Coronavac Vaccine and who have received at least one dose of the booster vaccine of TURKOVAC and have accepted the second booster dose vaccination, Individuals who have previously received the primary vaccination of the BioNTech Comirnaty Vaccine and who have received at least one dose of the booster vaccine of the TURKOVAC and who have agreed to the second booster dose vaccination. | Biological: Taking biological samples (blood) and keeping records with phone calls<br>* Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.<br>|
| Individuals who have only received TURKOVAC vaccine before<br>Only individuals who have previously been vaccinated of TURKOVAC will also be invited to be included in the study retrospectively. | Biological: Taking biological samples (blood) and keeping records with phone calls<br>* Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reactions | Incidence of adverse reactions in all subjects within 3 - 7 days after vaccination (phone call). | 3 - 7 days after vaccination | 
| Incidence of Serious Adverse Events (SAE) | Incidence of Serious Adverse Events (SAE) up to 365 days after vaccination in all subjects | 365 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels | Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels (from subjects available) immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days of 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) | Immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days of 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Effectiveness, Immunogenicity, Safety, Observational