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Booster Vaccination Against COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Booster Vaccination Against COVID-19

Double-Blind, Randomized, Controlled, Multi-Centered, Phase 2 Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2

NCT04979949•Health Institutes of Turkey

View on ClinicalTrials.gov

Summary

A booster dose of vaccine (Turkovac or CoronaVac) will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Detailed Description

To determine the safety and immunogenicity of booster doses of vaccine against SARS-CoV2 after a minimum of 90 days and a maximum of 270 days after the 2nd dose of a homologous 2 dose primary regimen. It is planned to recruit 111 subjects for 2 vaccines (Turkovac and CoronaVac). There will be a total of 222 subjects.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Signed informed consent
•Healthy male or female aged 18 - 60 years (including both groups)
•Subjects who were vaccinated with CoronaVac for 2 doses and who had a minimum of 90 days and a maximum of 270 days after the second dose
•Subjects may have a controlled or moderate comorbidity
•Female subjects of childbearing potential should be willing to ensure that they or their partner use effective birth control methods continuously from 1 month before and up to 3 months after vaccination
•Subjects agreed to comply with all study requirements
•Subjects are willing to share their medical history with their physician and allow access to all medical records when relevant to study procedures
•Subjects are willing to agree to abstain from donating blood during the study

Exclusion Criteria

•Subjects meeting any of the following criteria will be excluded from the study:
•Administration of any vaccine (registered or investigational) other than study intervention within 30 days before and after each study vaccine (one week for authorized seasonal flu vaccine or pneumococcal vaccine)
•Positive for COVID-19 after primary vaccination
•Pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine)
•Subjects who were pregnant at the time of enrollment or who plan to become pregnant within the first 3 months following vaccination and who are breastfeeding
•Subjects with fever (above 38°C) at the time of vaccination and/or up to 72 hours before
•Administration of immunoglobulins and/or any blood product within 3 months prior to vaccination
•Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; recurrent severe infections and use of immunosuppressants (less than ≤14 days) in the last 6 months, excluding topical steroids or short-term oral steroids
•Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines
•Any history of anaphylaxis
+16 more criteria

Locations (4)

Ankara City Hospital Internal Medicine Clinic

Ankara, Turkey (Türkiye)

Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic

Istanbul, Turkey (Türkiye)

T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases

Istanbul, Turkey (Türkiye)

Ümraniye Training and Research Hospital Infectious Diseases

Istanbul, Turkey (Türkiye)

Key Dates

Start Date

July 12, 2021

Primary Completion Date

March 9, 2022

Completion Date

June 6, 2022

Last Updated

November 29, 2023

Enrollment

222

ACTUAL participants

Conditions

COVID-19Sars-CoV-2 Infection

Interventions

CoronaVac

BIOLOGICAL

Turkovac

BIOLOGICAL

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Booster Vaccination Against COVID-19

Inclusion Criteria

Exclusion Criteria

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