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| Column | Value |
|---|---|
| Trial registration number | NCT04969601 |
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Full text link
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
arnaud.petit@aphp.fr |
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Registration date
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
2021-07-20 |
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Recruitment status
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
inclusion criteria: children aged 1 to 15 years old : with acute lymphoblastic leukemia undergoing chemotherapy (at least 2 weeks from the last injection of peg-asparaginase) or for whom the last chemotherapy is less than or equal to 12 months with acute myeloid leukemia within 12 months from the end of treatment healthy siblings aged 12 to 15 years old living in the same household than the child with al more than 50% of the time informed consent from parents patient affiliated to health insurance |
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Exclusion criteria
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
documented sars-cov-2 infection ongoing or that occurred less than 3 months ago known clinical allergy to polyethylene glycol (peg) pregnant woman during first pregnancy quarter or lactating woman platelet <50 giga(g) g/l or neutrophils <0.5 g/l at time of vaccination vaccination within 4 weeks from the 1st injection or planning to receive an approved vaccine 4 weeks after the last injection any hemorrhagic trouble considered as a contraindication to intramuscular injection history of severe adverse event after a vaccine administration including anaphylaxis and associated symptoms such as rash, respiratory issues, angioedema and abdominal pain, or history of allergic reaction that could be exacerbated by a vaccine component participant vaccinated against tuberculosis within the past year |
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Number of arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Assistance Publique - Hôpitaux de Paris |
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Inclusion age min
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
1 |
|
Inclusion age max
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
15 |
|
Countries
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
France |
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Type of patients
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
150 |
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primary outcome
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
co-primary endpoint: Increase in anti-Spike Immunoglobulin G (IgG) titer AND positive anti-Spike neutralizing test;Dose limiting toxicity (DLT) |
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Notes
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "10, 20, 30 \u00b5g (depending on the observed responses of previous children);2;21-28 days apart", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |