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| Column | Value |
|---|---|
| Trial registration number | NCT04999111 |
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Full text link
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
JNJ.CT@sylogent.com |
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Registration date
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
2021-08-10 |
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Recruitment status
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
unclear |
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Study aim
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
None |
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Exclusion criteria
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
6 |
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Funding
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Janssen Vaccines & Prevention B.V. |
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Inclusion age min
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
None |
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Type of patients
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Feb. 4, 2022, 1:30 p.m. Source : ClinicalTrials.gov |
1541 |
|
primary outcome
Last imported at : June 9, 2022, 4 p.m. Source : ClinicalTrials.gov |
Cohort 1: Groups 1, 2 and 3: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers, 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination with Ad26.COV2.S [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Serological response to vaccination as measured by VNA titers, 14 Days after Ad26.COV2.S (dose levels 1, 2 and 3) booster vaccination after completing primary vaccination with Ad26.COV2.S (dose level 1) will be reported. Cohort 1: Groups 1, 2 and 3: Antibody Titers as Measured by VNA Titers, 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination with Ad26.COV2.S [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Antibody titer as measured by VNA titers, 14 days after Ad26.COV2.S (dose levels 1, 2 and 3) booster vaccination after completing primary vaccination with Ad26.COV2.S (dose level 1) will be reported. Cohorts 1: Serological Response to Vaccination as Measured by VNA Titers, 28 Days After Primary Vaccination with Ad26.COV2.S [ Time Frame: 28 days after primary vaccination (Day 29) ] Serological response to vaccination as measured by VNA titers, 28 days after primary vaccination with Ad26.COV2.S (dose level 1) will be reported. Cohorts 1: Antibody Titer as Measured by VNA Titers, 28 Days After Primary Vaccination with Ad26.COV2.S [ Time Frame: 28 days after primary vaccination (Day 29) ] Antibody titer as measured by VNA titers, 28 days after primary vaccination with Ad26.COV2.S (dose level 1) will be reported. Cohort 1: Groups 1, 2 and 3: Serological Response to Vaccination as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern, 14 days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination with Ad26.COV2.S [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Serological response to vaccination as measured by VNA titers against the leading variant of high consequence or concern, 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S (dose level 1) will be reported. Cohort 1: Groups 1, 2 and 3: Antibody Titers as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern, 14 days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination with Ad26.COV2.S [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Antibody titers as measured by VNA titers against the leading variant of high consequence or concern, 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S (dose level 1) will be reported Cohort 1: Serological Response to Vaccination as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern, 28 days After Primary Vaccination with Ad26.COV2.S [ Time Frame: 28 days after primary vaccination (Day 29) ] Serological response to vaccination as measured by VNA titers against the leading variant of high consequence or concern, 28 days after primary vaccination with Ad26.COV2.S (dose level 1) will be reported. Cohort 1: Antibody Titers as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern, 28 days After Primary Vaccination with Ad26.COV2.S [ Time Frame: 28 days after primary vaccination (Day 29) ] Antibody titers as measured by VNA titers against the leading variant of high consequence or concern, 28 days after primary vaccination with Ad26.COV2.S (dose level 1) will be reported. Cohort 2: Groups 4, 5 and 6: Serological Response to Vaccination as Measured by VNA Titers, 14 Days After Ad26.COV2.S Booster Vaccination after Completing Primary Vaccination with BNT162b2 [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Serological response to vaccination as measured by VNA titers, 14 days after Ad26.COV2.S (dose levels 1, 2 and 3) booster vaccination after completing primary vaccination with BNT162b2 will be reported. Cohort 2: Groups 4, 5 and 6: Antibody Titer as Measured by VNA Titers, 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination with BNT162b2 [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Antibody titer as measured by VNA titers, 14 days after Ad26.COV2.S (dose levels 1, 2 and 3) booster vaccination after completing primary vaccination with BNT162b2 will be reported. Cohort 2: Serological Response to Vaccination as Measured by VNA Titers Against the Original Strain, in Pfizer BNT162b2 External Samples [ Time Frame: Up to 2 months after completing primary vaccination with Pfizer BNT162b2 ] Serological response to vaccination as measured by VNA titers against the original strain, in Pfizer BNT162b2 external samples will be reported. Cohort 2: Antibody Titers as Measured by VNA Titers Against the Original Strain, in Pfizer BNT162b2 External Samples [ Time Frame: Up to 2 months after completing primary vaccination with Pfizer BNT162b2 ] Antibody titers as measured by VNA titers against the original strain, in Pfizer BNT162b2 external Samples will be reported. Cohort 2: Groups 4, 5 and 6: Serological Response to Vaccination as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern, 14 Days After Ad26.COV2.S Booster Vaccination after Completing Primary Vaccination with BNT162b2 [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Serological response to vaccination as measured by VNA titers against the leading variant of high consequence or concern, 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 will be reported. Cohort 2: Groups 4, 5 and 6: Antibody Titers as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern, 14 Days After Ad26.COV2.S Booster Vaccination after Completing Primary Vaccination with BNT162b2 [ Time Frame: 14 days after booster vaccination after completing primary vaccination (Day 15) ] Antibody titers as measured by VNA titers against the leading variant of high consequence or concern, 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 will be reported. Cohort 2: Serological Response to Vaccination as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern in Pfizer BNT162b2 External Samples [ Time Frame: Up to 2 months after completing primary vaccination with Pfizer BNT162b2 ] Serological response to vaccination as measured by VNA titers against the leading variant of high consequence or concern in Pfizer BNT162b2 external samples will be reported Cohort 2: Antibody Titers as Measured by VNA Titers Against the Leading Variant of High Consequence or Concern in Pfizer BNT162b2 External Samples [ Time Frame: Up to 2 months after completing primary vaccination with Pfizer BNT162b2 ] Antibody titers as measured by VNA titers against the leading variant of high consequence or concern in Pfizer BNT162b2 external samples will be reported |
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Notes
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "dose level 1;1;IM;Ad26.COV2.S primary vaccination (>=) 6 months prior", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "dose level 2;1;IM;Ad26.COV2.S primary vaccination (>=) 6 months prior", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "dose level 3;1;IM;Ad26.COV2.S primary vaccination (>=) 6 months prior", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "dose level 1;1;IM;BNT162b2 primary vaccination (>=) 6 months prior", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "dose level 2;1;IM;BNT162b2 primary vaccination (>=) 6 months prior", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "dose level 3;1;IM;BNT162b2 primary vaccination (>=) 6 months prior", "treatment_id": 24, "treatment_name": "Ad26.cov2.s", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}] |