Multicenter,Randomized,Observational Blind Phase IIB Clinical Trial to Evaluate the Effectiveness,Immunogenicity and Safety of Two Doses of CoronaVac (Sinovac) Vaccine Against Two Doses of Inactivated COVID-19 Vaccine (TURKOVAC) in Healthy Adolescent (12-18 Years) Subjects

Health Institutes of Turkey14 sites in 1 country1 target enrollmentFebruary 18, 2022

ConditionsCOVID-19 Sars-CoV-2 Infection

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Health Institutes of Turkey
Enrollment: 1
Locations: 14
Primary Endpoint: COVID-19 Positivity Rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a multi-center, randomized, national, observer-blinded, active-controlled phase IIB clinical trial to determine the efficacy, immunogenicity, and safety of two-doses of inactive COVID-19 vaccine (TURKOVAC) vaccine versus the two-doses CoronaVac (Sinovac) vaccine in healthy adolescents aged 12-18 years.

Detailed Description

The primary aim of the study is to evaluate the clinical efficacy of two-doses of TURKOVAC and two-doses of CoronaVac vaccines against symptomatic COVID-19 disease confirmed by real time-polymerase chain reaction (RT-PCR) in adolescents (12-18 years of age). After the second dose of vaccine administration, the immunological responses of TURKOVAC and CoronaVac vaccines will be demonstrated by neutralizing antibodies and anti-spiked antibodies. A total of 644 subjects will be enrolled. Subjects will be assigned according to randomization (1:1) for 2 different arms. The assigned vaccine will be administered to subjects in two doses on days 0 and 28.

Registry

clinicaltrials.gov

Start Date

February 18, 2022

End Date

February 8, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Health Institutes of Turkey

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Each subject must meet all the following criteria to be enrolled in this study:
•Subjects who can voluntarily consent to participate in the study with their parents or legal representatives,
•Subjects agreed to comply with all study visits and procedures (consented to give blood sample and nasopharyngeal swab, and receiving automated telephone calls from the study site),
•No history of SARS-CoV-2 (within the last 12 months),
•Consent of sexually active females to use effective contraception during the study,
•Adolescent males or females who were at least 12 years old and not older than 18 years of age on the date of the informed consent signature,
•In the opinion of the investigator, subjects who can comply with the study protocol during the study,
•According to the vaccination program of the Ministry of Health, meeting the criteria for vaccination however, who voluntarily choose not to be vaccinated when rights are granted and subjects who agreed to receive one of the vaccines to be used in this study,
•Not participating in another clinical trial.

Exclusion Criteria

•Subjects meeting any of the following criteria will be excluded from the study:
•Is acutely ill or febrile within 48 hours before or use of antipyretic or analgesic medication within 24 hours before planned administration of study vaccine. (Fever is defined as a body temperature is 38.0 °C. Subjects with mild illness and fever may be enrolled in the study at the discretion of the investigator),
•Those who have used more than a single dose of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in the last 24 hours for a reason other than fever,
•Subjects who are pregnancy or breastfeeding plan within (at least) 1 year following the second dose of vaccine,
•Those with a history of SARS-CoV-2 (within the last 12 months),
•Individuals with a current positive (PCR-based viral RNA detection) or past positive (serological testing or PCR-based viral RNA detection) diagnostic test result for SARS-CoV-2 infection,
•Prior administration of an investigational or approved coronavirus (SARS-CoV, SARS-CoV-2, MERS-CoV) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19,
•Subjects with a history of cardiac diseases (cardiovascular disease, serious arrythmia, coronary artery disease, heart failure, cardiomyopathies, pulmonary hypertension etc.),
•Subjects with uncontrolled hypertension,
•Subjects with a first-degree relative with a history of coronary artery disease at an early age (presence of coronary artery disease before 55 years of age in males and 65 years of age in females),

Outcomes

Primary Outcomes

COVID-19 Positivity Rate

Time Frame: 14 days after the second dose of vaccination

The rate of positivity in a polymerase chain reaction (PCR) sample taken within 24 or 48 hours in subjects (symptomatic subject) with fever and other COVID-19 symptoms 14 days after the second vaccination dose.

Secondary Outcomes

The Seropositivity Rate of SARS-CoV2 Specific Binding Antibody(42, 56, 70, 126, 168, and 224 days after the first dose of vaccination)
Protection rates of TURKOVAC and CoronaVac Vaccines Against Symptomatic COVID-19(14 days after second dose of vaccination)
The Incidence of Adverse Events (AEs)(Up to 30 minutes each dose of vaccination)
The Incidence of Local and Systemic Signs and Symptoms(Through study completion, an average of 1 year)
The Incidence of Undesirable Adverse Event(7 days after each vaccination dose)
Evaluation of SARS-CoV2 Neutralizing Antibodies(42, 56, 70, 126, 168, and 224 days after the first dose of vaccination)
Protection Rates of TURKOVAC and CoronaVac Vaccines Against Symptomatic COVID-19(14 days after first dose of vaccination)
The Incidence of Serious Undesirable Adverse Events(1 year after first and second dose vaccination)
T-Cell Evaluation(70, 126, and 224 days after the first dose of vaccination)
The Protection Rates of TURKOVAC and CoronaVac Vaccines in Preventing Hospitalization and Death Against Severe COVID-19(14 days after second dose of vaccination)