Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium
NCT ID: NCT05618548
Last Updated: 2022-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
110 participants
OBSERVATIONAL
2021-03-01
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A: Pregnant women vaccinated with a mRNA COVID-19 vaccine
Pregnant women who will be offered a mRNA COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Gestational age at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.
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).
Cohort B: Pregnant women vaccinated with an adenoviral vector COVID-19 vaccine
Pregnant women who will be offered an adenoviral vector COVID-19 vaccine (Astra Zeneca). Gestational age at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.
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).
Cohort C: Postpartum lactating women vaccinated with a mRNA COVID-19 vaccine
Non-pregnant women during lactation (postpartum) will be offered a mRNA COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Duration of lactation at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.
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).
Cohort D: Postpartum lactating women vaccinated with an adenoviral vector COVID-19 vaccine (N=40)
Non-pregnant women during lactation (postpartum) will be offered an adenviral vector COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Duration of lactation at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent.
* Willing to be 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Vrije Universiteit Brussel
OTHER
Sciensano
OTHER_GOV
Université Libre de Bruxelles
OTHER
Universiteit Antwerpen
OTHER
Responsible Party
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Elke Leuridan, MD, PhD
Principal Investigator
Principal Investigators
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Elke Leuridan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Kirsten Maertens, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Larissa De Brabandere, MD
Role: PRINCIPAL_INVESTIGATOR
Universiteit Antwerpen
Locations
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Centre for the Evaluation of Vaccination
Antwerp, , Belgium
Countries
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References
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Munoz FM, Avila Aguero ML, Cutland CL, Dinleyici EC, Eckert LO, Giles ML, Holder B, Jones CE, Kampmann B, Kollman TR, Levy O, Marchant A, Maertens K, Marshall HS, Sadarangani M, Ulloa Gutierrez R, Van Damme P, Heath PT. Fostering Collaboration Across Nations: Report of the 6th International Neonatal and Maternal Immunization Symposium (INMIS), Costa Rica, 2024. Pediatr Infect Dis J. 2025 Feb 1;44(2S):S2-S8. doi: 10.1097/INF.0000000000004700. Epub 2025 Feb 14. No abstract available.
Other Identifiers
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cev004
Identifier Type: -
Identifier Source: org_study_id
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