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Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) in Healthy Pregnant Women | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

NCT06997653•Health Institutes of Turkey

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects willing and able to give signed informed consent to participate in study,
•2. Healthy pregnant female subjects aged 18 - 45 years (including both groups),
•3. Females in the second trimester of pregnancy (weeks 13 to 27) and in the third trimester (from week 28 to week 40),
•4. Females who were previously vaccinated with two doses of inactivated vaccine also 3 months after their last menstrual period and more than 3 months have passed since they have vaccinated for their last dose,
•5. Females without a current positive (real time-polymerase chain reaction (RT-PCR) - based viral RNA (Ribonucleic Acid) detection) or past (serological test or real time-polymerase chain reaction (RT-PCR -based viral RNA (Ribonucleic Acid) detection) positive diagnostic test result for SARS-CoV-2 infection,
•6. In the opinion of the investigator, subjects capable and willing to comply with all study requirements,
•7. Subjects who agree to comply with all study visits and procedures (who consent to blood and nasopharyngeal swab collection and who can answer automated phone calls from the study center).

Exclusion Criteria

•Subjects meeting any of the following criteria will be excluded from the study:
•1. Subjects with fever (above 37,8°C) at the time of vaccination and/or up to 72 hours before (subjects may be screened again after acute condition has resolved),
•2. Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines,
•3. Any history of anaphylaxis,
•4. Subjects with a medical or obstetric history that puts them at higher risk for maternal or fetal complications (e.g. chronic pregnancy-related disorders, birth defects, or genetic conditions during a previous pregnancy),
•5. Subjects with an abnormal uterine cavity shown on hysterosalpingography or hysteroscopy,
•6. Subjects with an abnormal pregnancy screening test (e.g. ultrasound fetal abnormalities, maternal blood screening),
•7. Subjects with a history of malignancy within 2 years prior to screening (exceptions are squamous, basal cell carcinomas of the skin, carcinomas in situ of the cervix, or malignancy considered treated with minimal risk of recurrence),
•8. Females with the presence of hydrosalpinx or endometrial polyp that are not treated surgically,
•9. Females with the poor ovarian response (less than 3 mature follicles),
+12 more criteria

Locations (1)

T.R. Ministry of Health Ankara City Hospital, Gynecology and Obstetrics Hospital

Ankara, Turkey, Turkey (Türkiye)

Key Dates

Start Date

January 1, 2024

Primary Completion Date

January 1, 2024

Completion Date

January 1, 2024

Last Updated

May 30, 2025

Conditions

COVID-19SARS CoV 2 Infection

Interventions

TURKOVAC

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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: May 30, 2025Data 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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Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) in Healthy Pregnant Women

Inclusion Criteria

Exclusion Criteria

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