Observational National Vaccine Study

May 16, 2023 updated by: Health Institutes of Turkey

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara City Hospital Internal Medicine Clinic
      • Bolu, Turkey, 14280
        • T.R. Ministry of Health Abant Izzet Baysal University Training and Research Hospital
      • Eskişehir, Turkey, 26080
        • Eskişehir City Hospital Internal Medicine
      • Istanbul, Turkey, 34865
        • T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases
      • Kayseri, Turkey, 38080
        • Kayseri City Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology
      • Kayseri, Turkey, 38280
        • Erciyes University Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
      • Kocaeli, Turkey, 41310
        • Health Sciences University Derince Training and Research Hospital
      • Trabzon, Turkey
        • Health Sciences University Kanuni Training and Research Hospital Infectious Diseases and Clinical Microbiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy adults aged 18 years and older

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals who have never been vaccinated against COVID-19
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
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.
Previously primary vaccinated individuals
  1. Those who have previously received two doses of Sinovac - Coronavac vaccine, who will receive the booster vaccine for the first time as TURKOVAC;
  2. Those who have previously received two doses of the BioNTech Comirnaty vaccine, who will receive the booster vaccine for the first time as TURKOVAC;
  3. 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,
  4. 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
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.
Individuals who have only received TURKOVAC vaccine before
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse reactions
Time Frame: 3 - 7 days after vaccination
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)
Time Frame: 365 days after vaccination
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
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microneutralization levels
Time Frame: 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)
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
Time Frame: 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
At least 14 days after the second dose of TURKOVAC vaccine
Neutralizing antibody (pseudo neutralization-Neutralizing Anti Spike/RBD Antibody) levels and microneutralization levels
Time Frame: 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
Before the fourth dose of TURKOVAC vaccine is given and on the 28th (±2 days) day following the booster dose of vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Institutes of Turkey

Investigators

  • Study Director: İhsan Ateş, Assoc. Prof., Assoc. Prof.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBS-VAC-COV-TUR-GF4.07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19 Infection

Clinical Trials on Taking biological samples (blood) and keeping records with phone calls

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe