NCT06997653

Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) in Healthy Pregnant Women

Open-Label, Phase 2b Clinical Trial to Determine Efficacy, Safety, and Immunogenicity of Inactivated COVID-19 Vaccine (TURKOVAC) Against SARS-CoV-2 in Healthy Pregnant Women

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label and Phase 2b clinical trial of the COVID-19 inactivated TURKOVAC vaccine against SARS-CoV-2 in healthy pregnant women.

Detailed description

The main purpose of this study is pregnant women who are at least in the second (13th to 27th weeks) and third (28th to 40th weeks) trimesters, to evaluate of the safety of two doses of TURKOVAC vaccine in who are naive (never vaccinated) and previously vaccinated with two doses of inactivated COVID-19 vaccine. It is planned to include 30 healthy pregnant subjects between the ages of 18-45 (including both age groups) in the study. After the safety and immunogenicity data obtained from the interim analysis of 30 pregnant female subjects, it will be planned to increase the number of subjects.

Conditions

• COVID-19
• SARS CoV 2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	TURKOVAC	Inactive COVID-19 Vaccine - TURKOVAC

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: Turkey (Türkiye)