| Trial registration number
|
NCT04978038 |
Full text link
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
https://clinicaltrials.gov/show/NCT04978038
|
First author
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Mark Loeb, MD
|
Contact
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
loebm@mcmaster.ca
|
Registration date
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
2021-07-27
|
Recruitment status
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Not recruiting
|
Study design
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
RCT
|
Allocation
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Randomized
|
Design
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Parallel
|
Masking
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Blind label
|
Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
|
single-center
|
Study aim
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Prevention
|
Inclusion criteria
Last imported at : May 27, 2022, 11 a.m.
Source : ClinicalTrials.gov
|
inclusion criteria:
ltcf residents ≥ 65 years who have received three doses of mrna vaccine.
|
Exclusion criteria
Last imported at : May 27, 2022, 11 a.m.
Source : ClinicalTrials.gov
|
immunocompromised individuals due to known or suspected immunodeficiency or due to receipt of immunosuppressive medication (e.g., steroids, biologics).
having had a severe adverse reaction (e.g., anaphylactic allergy) to mrna or pneumococcal vaccine.
having received pneumococcal polysaccharide vaccine within 12 months.
ltcf residents who have an interval less than 3 months from their third mrna covid vaccine dose.
|
Number of arms
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
2
|
Funding
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Mark Loeb
|
Inclusion age min
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
65
|
Inclusion age max
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
100
|
Countries
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Canada
|
Type of patients
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
High risk patients
|
Severity scale
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
N/A
|
Total sample size
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
414
|
primary outcome
Last imported at : May 27, 2022, 11 a.m.
Source : ClinicalTrials.gov
|
Detection of neutralizing antibodies
|
Notes
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
None
|
Phase
Last imported at : July 28, 2021, noon
Source : ClinicalTrials.gov
|
Phase 4
|
Arms
Last imported at : May 27, 2022, 11 a.m.
Source : ClinicalTrials.gov
|
[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1006, "treatment_name": "Pneumococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]
|