NCT05230940

Efficacy, Immunogenicity, and Safety of TURKOVAC Vaccine Versus the CoronaVac Vaccine Against COVID-19 in Healthy Adolescent

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19
• Sars-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	TURKOVAC	Inactive COVID-19 Vaccine - TURKOVAC
BIOLOGICAL	CoronaVac	It has 600 subunit of SARS-CoV-2 virus antigen

Timeline

• Start date: 2022-02-18
• Primary completion: 2023-05-15
• Completion: 2024-02-08
• First posted: 2022-02-09
• Last updated: 2024-05-28

Locations

14 sites across 1 country: Turkey (Türkiye)