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OpenTrials
Completed

NCT Number: NCT05863429

Observational National Vaccine Study

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.

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Key information

Conditions

COVID-19 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital Internal Medicine Clinic, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

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.

Primary outcomes

  1. 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).

  2. 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

Secondary outcomes

  1. 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)

Other outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Health Institutes of Turkey

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 18, 2023
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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