NCT05618548

Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium

Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium: a Non-commercial Multicenter Academic Prospective Cohort Study in Pregnant and Lactating Women

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Universiteit Antwerpen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will investigate whether pregnant and lactating women can develop similar protective immunity as non-pregnant women against Coronavirus Infectious Disease 2019 (COVID-19) upon vaccination, without safety issues. Immunogenicity and safety of all currently licensed COVID-19 vaccines that are administered to pregnant and lactating women in Belgium will be studied.

Detailed description

This project will compare vaccination of pregnant women with age-matched non-pregnant women and women vaccinated in the postpartum period during lactation. The primary objectives are to assess the immune responses (humoral immunity, cellular immunity, mucosal immunity) and safety after either administration of the Comirnaty COVID-19 vaccine (mRNA, Pfizer BioNtech), the COVID-19 Moderna vaccine (mRNA, Moderna), the COVID-19 vaccine Vaxzevria (Viral Vector, Astra Zeneca) or any other vaccine that will become available for the Belgian population.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 vaccine	COVID-19 vaccine available at the moment of vaccination: either the Comirnaty vaccine (mRNA, Pfizer BioNtech), the Moderna vaccine (mRNA, Moderna), the Vaxzevria vaccine (Viral Vector, Astra Zeneca).

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2022-11-16
• Last updated: 2022-11-16

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study