drugset / Trial / NCT06997653
Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) in Healthy Pregnant Women
NaSingle-groupOpen-labelPrevention
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.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
Publications
- Background Kumar A, Singh R, Kaur J, Pandey S, Sharma V, Thakur L, Sati S, Mani S, Asthana S, Sharma TK, Chaudhuri S, Bhattacharyya S, Kumar N. Wuhan to World: The COVID-19 Pandemic. Front Cell Infect Microbiol. 2021 Mar 30;11:596201. doi: 10.3389/fcimb.2021.596201. eCollection 2021.
- Background Pavel STI, Yetiskin H, Aydin G, Holyavkin C, Uygut MA, Dursun ZB, Celik I, Cevik C, Ozdarendeli A. Isolation and characterization of severe acute respiratory syndrome coronavirus 2 in Turkey. PLoS One. 2020 Sep 16;15(9):e0238614. doi: 10.1371/journal.pone.0238614. eCollection 2020.
- Background Limaye MA, Roman AS, Trostle ME, Venkatesh P, Lantigua Martinez M, Brubaker SG, Chervenak J, Wei LS, Sahani P, Grossman TB, Meyer JA, Penfield CA. Predictors of severe and critical disease in pregnant women with SARS-CoV-2. J Matern Fetal Neonatal Med. 2022 Dec;35(25):7536-7540. doi: 10.1080/14767058.2021.1951216. Epub 2021 Sep 1.
- Background Adhikari EH, Spong CY. COVID-19 Vaccination in Pregnant and Lactating Women. JAMA. 2021 Mar 16;325(11):1039-1040. doi: 10.1001/jama.2021.1658. No abstract available.
- Background Goncu Ayhan S, Oluklu D, Atalay A, Menekse Beser D, Tanacan A, Moraloglu Tekin O, Sahin D. COVID-19 vaccine acceptance in pregnant women. Int J Gynaecol Obstet. 2021 Aug;154(2):291-296. doi: 10.1002/ijgo.13713. Epub 2021 May 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TURKOVAC | Vaccine | — | — |