COVID-19 Infection
Conditions
Keywords
COVID-19, Effectiveness, Immunogenicity, Safety, Observational
Brief summary
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
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.
Interventions
BIOLOGICALTaking biological samples (blood) and keeping records with phone calls
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.
Sponsors
Health Institutes of Turkey
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who meet all of the following criteria will be included in the study: 1. Individuals aged 18 and over, 2. 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), 3. Individuals who have not had COVID-19 during the last trimester, 4. 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, 5. 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, 6. Individuals who will be able to voluntarily understand and sign informed consent, 7. 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. 1. 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. 2. Individuals who have chosen a vaccine other than TURKOVAC as a booster dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse reactions | 3 - 7 days after vaccination | Incidence of adverse reactions in all subjects within 3 - 7 days after vaccination (phone call). |
| Incidence of Serious Adverse Events (SAE) | 365 days after vaccination | Incidence of Serious Adverse Events (SAE) up to 365 days after vaccination in all subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels | 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) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Microneutralization levels | Immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) | Microneutralization levels (from subjects available) immediately before the first dose of TURKOVAC vaccine (day 0) and on the following days 28 (±2 days), 48 (±5 days), 84 (±5 days), and 168 (±10 days) |
| Determine the confirmed COVID-19 case rates | At least 14 days after the second dose of TURKOVAC vaccine | To determine the confirmed COVID-19 case rates by symptomatic RT-PCR at least 14 days after the second dose of TURKOVAC vaccine |
| Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels | Before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine | Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels (from subjects available) just before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine |
Countries
Turkey (Türkiye)
Outcome results
None listed