Safety and Immunological Responses after COVID-19 vaccination in Thai Pregnant Wome
- Conditions
- Pregnancy outcomes following COVID-19 pregnancy in Thai womenCOVID-19, vaccination, pregnant, Thai
- Registration Number
- TCTR20210717002
- Lead Sponsor
- ational Research Council of Thailand (NRCT)
- Brief Summary
Heterologous schedules of CoronaVac-BNT162b2 or ChAdOx1-BNT162b2 induced immunogenicity on-par with BNT162b2-BNT162b2 and may be considered as alternative schedules for primary series in pregnant women in mRNA-limited vaccine settings.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 165
1. Singleton pregnancy
2. Alive, intrauterine pregnancy
3. Gestational age >12 weeks
4. Literacy in Thai
5. Thai language literacy
6. Able to use applications e.g. Google form, Line
7. Able to comply follow-up schedules
8. Willing to participate in the study
1. History of uterine bleeding >2 times in the current pregnancy
2. Having uterine bleeding on the enrollment day
3. History of or having pre-eclampsia, abnormal placental position, preterm labor, fetal growth restriction
4. History of cigarettes smoking, alcohol drinking, recreational drugs
5. Recent immunization in prior 14 days
6. Previous COVID-19 immunization
7. Detection of COVID-19 in prior 90 days
8. Blood transfusion in prior 90 days
9. History of severe drug hypersensitivity
10. Type 1, 2 diabetes mellitus
11. Hypertension
12. Having uncontrollable diseases
13. Immunocompromised conditions, including steroid use
14. Investigators' judgement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events Delivery Descriptive statistics
- Secondary Outcome Measures
Name Time Method Antibody response Delivery Descriptive statistics