Persistence of anti-SARS-CoV2 antibodies in infants born during 2021-2023 to the mothers who had received COVID-19 vaccination during pregnancy
- Conditions
- Persistence of transplacental antibodies, acquired from maternal COVID-19 vaccination or SARs-CoV-2 infection during pregnancy, in infants age less than 6 months old.COVID-19 vaccine, anti-SARs-CoV-2 antibodies, antibody, pregnant women, neonate
- Registration Number
- TCTR20230324006
- Lead Sponsor
- ational Vaccine Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 250
Healthy neonates or infants, aged 0 days to 4 months old, (gestational age more than 32 weeks at birth) born to mothers aged 18 to 45 years old who received at least 1 dose of any COVID-19 vaccine types (mRNA, viral-vector or inactivated vaccine) in any of the following period:
- at least 1 dose or recent booster dose within 3 months before pregnancy
- during pregnancy but not exceed 2 weeks before delivery
Neonates or infants who had any medical-related problems for example preterm (GA < 32 weeks at birth), congenital anomalies, severe birth infection or complications, immune deficiency and receiving any blood components products or immunomodulators as well as pregnant women with severe medical illnesses (e.g., exposure to immunosuppressive drugs, HIV infection, severe sepsis) that might affect antibody responses must be excluded from this study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Persistence of antibodies after the end of recriutment geometric mean
- Secondary Outcome Measures
Name Time Method breastfeeding after the end of recruitment breakthrogh COVID-19 infection