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Trial - NCT04756271


Column Value
Trial registration number NCT04756271
Full text link
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Noha M Hammad

Contact
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

daaboelelaa@medicine.zu.edu.eg

Registration date
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-02-16

Recruitment status
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

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

single-center

Study aim
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: -healthy healthcare workers

Exclusion criteria
Last imported at : Feb. 23, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- healthy healthcare workers' refusal. - pregnancy and lactation. - confirmed acute cases of sars-cov-2 infection - having a history of sars-cov-2 infection in the past 3 months. - fever (body temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination. - history of allergy to any vaccines - previous vaccination within the last 30 days

Number of arms
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

1

Funding
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Zagazig University

Inclusion age min
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Egypt

Type of patients
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Health workers

Severity scale
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Feb. 11, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

246

primary outcome
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Incidence of adverse reactions;Seroconversion rate of neutralizing antibody

Notes
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Feb. 18, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "2;day0-21", "treatment_id": 1168, "treatment_name": "Sars-cov-2 vaccine (inactivated)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]