Pregnant women COVID-19 SARS-CoV-2 vaccine Vaccine Pregnant BBIBP-CorV Sinopharm
Conditions
Interventions
Vaccinated Thai pregnant women with BBIBP-CorV at 1 course (2 dose at interval 28 days)
Experimental Biological/Vaccine
BBIBP-CorV vaccination
Sponsors
Chulabhorn Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Thai pregnant women, vaccinated with BBIBP-CorV at Chulabhorn Hospital - Age at least 18 years old - Gestational age at 1st vaccinated at least 12 complete weeks, confirmed by ultrasonographic measurement - Willing to keep contact for information after vaccinated - No history of fever or illness within 14 days before vaccinated - Not been diagnosed of SARS-CoV-2 infected - Not been vaccinated with any other type SARS-CoV-2 vaccine
Exclusion criteria
Exclusion criteria: - Deny to complete 2-doses of BBIBP-CorV vaccine - Multiple gestation - Immunocompromised or receiving immunosupressive agents - Anaphylaxis allergic reaction to BBIBP-CorV vaccine - Diagnosed with any congenital infections such as Rubella, Toxoplasmosis, Parvovirus B-19, Zika virus or Syphilis - Fetal structural or chromosome abnormalities, or abnormal prenatal aneuploidy screening has not yet been confirmed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity after BBIBP-CorV vaccination 1 month after completed vaccination Immunoglobulin and neutralizing antibody to SARS-CoV-2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of BBIBP-CorV vaccination After vaccinated at 7 and 30 days of each doses Complications and side effects of vaccine,Safety of BBIBP-CorV vaccination 1 month after completed vaccination Fetal growth and fetal well being monitoring,Safety of BBIBP-CorV vaccination At delivery Obstetrics outcomes,Safety of BBIBP-CorV vaccination Until 3 months after delivery Neonatal outcomes | — |
Countries
Thailand
Contacts
Public ContactRajavadi Tanvisut
Chulabhorn Hospital
Outcome results
None listed