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Trial - NCT05767606


Column Value
Trial registration number NCT05767606
Full text link
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05767606

First author
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Markus Zeitlinger

Contact
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

2023-03-14

Recruitment status
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

inclusion criteria: age: 60 years or older males and females able and willing (in the investigator's opinion) to comply with all study requirements. participants, who already received three covid-19 vaccines, of which the third was a mrna vaccine (bnt162b2 or mrna-1273) and at least 16 weeks ago only applicable for women: last menstrual bleeding more than one year ago

Exclusion criteria
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

use of immunosuppressants congenital or acquired immunodeficiency (eg, history of hiv infection, hematological disease, current malignancy, or others) chronic condition that may significantly interfere with the immune response in the opinion of the investigator history of covid-19 within 16 weeks before study vaccination previous pneumococcal vaccination contraindication against any ingredient of the nvx or the pcv20 vaccine

Number of arms
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Medical University of Vienna

Inclusion age min
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

60

Inclusion age max
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

256

primary outcome
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Immunogenicity

Notes
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 918, "treatment_name": "Nvx-cov2373", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 1006, "treatment_name": "Pneumococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 2695, "treatment_name": "Nvx-cov2373+pneumococcal vaccine", "treatment_type": "Protein subunit+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]