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

Phase 1

• Conditions: Vaccine responses to COVID19 vaccines administered in pregnant andlactating women; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000440-22-BE
• Lead Sponsor: niversiteit Antwerpen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-25
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 420

Inclusion Criteria

• Female population older than 18 years.
• Ability to provide informed consent.
• Being vaccinated with a COVID-19 vaccine.
• Intend to be available for follow-up visits through one year
postvaccination.
• Influenza and pertussis vaccination during pregnancy (as per Belgian
recommendations) is allowed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 420
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Serious underlying immunological condition (e.g. immunosuppressive
disease or therapy, human immunodeficiency virus (HIV) infection…).
• Systemic treatment with immune suppressive medication, including
chronic steroid use of > 10 mg prednisone or equivalent.
• Anything in the opinion of the investigator that would prevent
volunteers from completing the study or put the volunteer at risk.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified