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| Column | Value |
|---|---|
| Trial registration number | EUCTR2021-000440-22-BE |
|
Full text link
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000440-22/BE |
|
First author
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
|
|
Contact
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
kirsten.maertens@uantwerpen.be |
|
Registration date
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
2021-02-25 |
|
Recruitment status
Last imported at : Jan. 5, 2025, 10:55 p.m. Source : EU Clinical Trials Register |
Completed |
|
Study design
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
nonRCT |
|
Allocation
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Non-randomized |
|
Design
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Single group assignment |
|
Masking
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Open label |
|
Center
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
single-center |
|
Study aim
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Prevention |
|
Inclusion criteria
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
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. |
|
Exclusion criteria
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
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. |
|
Number of arms
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
3 |
|
Funding
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Universiteit Antwerpen |
|
Inclusion age min
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
18 |
|
Inclusion age max
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
65 |
|
Countries
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Belgium |
|
Type of patients
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Healthy volunteers |
|
Severity scale
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
N/A |
|
Total sample size
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
420 |
|
primary outcome
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
To investigate the antibody based immune response (ELISA RBD antibodies (IgG) ) on day 28 after the second vaccination in pregnant women, age matched control non-pregnant women and postpartum lactating women. The definition of response will be based on a serological correlate of protection for COVID-19 based on SARS-CoV-2 spike(S)-protein specific serum IgG antibody levels (in IU/mL or seroconversion (a≥4-fold increase of the geometric mean concentration (GMC) of anti-S protein IgG antibodies over baseline)). For those with a previous COVID infection, the in house multiplex assay from Sciensano will be performed to discriminate between previous infection and vaccination |
|
Notes
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
nan |
|
Phase
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Phase 4 |
|
Arms
Last imported at : April 21, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
[{"arm_notes": "2;Pregnant and lactating women", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Pregnant and lactating women", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Pregnant and lactating women", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |