Immunogenicity and safety after vaccinated with BBIBP-CorV (COVID-19 vaccine) in Thai pregnant wome

Phase 3

• Conditions: Pregnant women; COVID-19; SARS-CoV-2 vaccine; Vaccine; Pregnant; BBIBP-CorV; Sinopharm

• Registration Number: TCTR20210923013
• Lead Sponsor: Chulabhorn Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-23
• Study Completion: 2022-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 400

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity after BBIBP-CorV vaccination 1 month after completed vaccination Immunoglobulin and neutralizing antibody to SARS-CoV-2

Secondary Outcome Measures

Name	Time	Method
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