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| Column | Value |
|---|---|
| Trial registration number | NCT05471440 |
|
Full text link
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Feb. 16, 2023, noon Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Feb. 16, 2023, noon Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
2022-07-22 |
|
Recruitment status
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Not recruiting |
|
Study design
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: participant is willing and able to give written informed consent for participation in the trial. adult (male/female) between 18 and 65 years old sufficient level of the dutch language to undertake all study requirements |
|
Exclusion criteria
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
adults younger than 18 or older than 65 years. adults primed with another vaccine than janssen, moderna or pfizer. history of allergic reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the smpc-listed ingredients of the janssen/pfizer/moderna vaccine). adults that are pregnant. currently being treated for cancer. severe kidney failure or dialyses dependent. status after organ-, stem cell- or bone marrow transplantation. use of immunosuppressant's. epilepsy. hiv. bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following im injections of vene puncture. continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc). participants who are currently participating in another research trial. all regular contra-indications of the vaccines will be applied. |
|
Number of arms
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
4 |
|
Funding
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Erasmus Medical Center |
|
Inclusion age min
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
67 |
|
Countries
Last imported at : Feb. 16, 2023, noon Source : ClinicalTrials.gov |
Netherlands |
|
Type of patients
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
N/A |
|
Total sample size
Last imported at : Feb. 16, 2023, noon Source : ClinicalTrials.gov |
431 |
|
primary outcome
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Does booster vaccination lead to a rapid secondary recall response, indicative of immunological memory?;Is there an increase in antibody levels between day of boost and 28 days after boosting HCW that were initially primed with either the Janssen or an mRNA-based vaccine? |
|
Notes
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : July 23, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Direct boost", "treatment_id": 831, "treatment_name": "Mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Post-poned boost", "treatment_id": 831, "treatment_name": "Mrna vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Direct boost", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Post-poned boost", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |