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Trial - NCT05212948


Column Value
Trial registration number NCT05212948
Full text link
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05212948

First author
Last imported at : July 29, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : July 29, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

2022-01-28

Recruitment status
Last imported at : July 27, 2023, 4 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Crossover

Masking
Last imported at : Jan. 29, 2022, 11:30 a.m.
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 : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

inclusion criteria: agree not to participate in any other sars-cov-2 prevention trial during the study follow-up. capable of using diary without difficulties (if applicable, with assistance by caregiver).

Exclusion criteria
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

current or history of a laboratory-confirmed diagnosis of sars-cov-2 infection or covid-19. unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation. immunosuppression (immunodeficiency, acquired immunodeficiency syndrome [aids], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy). previous vaccination against sars-cov-2. any inactivated vaccine received within 14 days prior to the first dose of study intervention. any live vaccine received within 28 days prior to the first dose of study intervention. immunoglobulin preparations, blood products, or a blood transfusion within 3 months prior to the first dose of study intervention. other inclusion and exclusion criteria may apply.

Number of arms
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Shionogi

Inclusion age min
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Vietnam

Type of patients
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : July 27, 2023, 4 a.m.
Source : ClinicalTrials.gov

9902

primary outcome
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Number of Participants With First Occurrence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 in the Initial Vaccination Period

Notes
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Jan. 29, 2022, 11:30 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2;Days1-29;IM then placebo IM Days225-253", "treatment_id": 2142, "treatment_name": "S-268019-b", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days225-253;IM prior placebo IM Days1-29", "treatment_id": 2142, "treatment_name": "S-268019-b", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]