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Clinical Trials/EUCTR2021-000440-22-BE
EUCTR2021-000440-22-BE
Active, not recruiting
Phase 1

Vaccination against COVID-19 in Pregnant and Lactating Women in Belgium - PREGCOVAC.BE

niversiteit Antwerpen0 sites420 target enrollmentFebruary 25, 2021
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ConditionsVaccine responses to COVID19 vaccines administered in pregnant andlactating womenTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsComirnatyCovid-19 Vaccine ModernaCOVID19 Vaccine Astrazeneca

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Vaccine responses to COVID19 vaccines administered in pregnant andlactating women
Sponsor
niversiteit Antwerpen
Enrollment
420
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 25, 2021
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
niversiteit Antwerpen

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

Not specified

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