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Trial - NCT05585567


Column Value
Trial registration number NCT05585567
Full text link
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05585567

First author
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

2022-10-19

Recruitment status
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Crossover

Masking
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

inclusion criteria: adults aged 18 -59 years old at time of consent, male or female; normal body temperature; participants who have completed 3-dose regimen of inactive vaccination (coronavac) against sars-cov-2 wild type in the past 5-9 months; female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment; be able and willing to complete the study during the entire study and follow-up period; participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.

Exclusion criteria
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

serious chronic diseases or uncontrolled diseases; uncontrolled neurological disorders, epilepsy; received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks; patients with congenital or acquired immunodeficiency; history of severe allergy or be allergic to any components of the test vaccines; history of hereditary hemorrhagic tendency or coagulation dysfunction; patients with malignant tumors and other patients have a life expectancy less than 1 year; refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol; history of previous covid-19 infection; pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study; participants who have participated in other clinical trials within 3 months or are participating in other clinical trials; those considered by the investigator as inappropriate to participate in the study.

Number of arms
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

3

Funding
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Livzon Pharmaceutical Group Inc.

Inclusion age min
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

59

Countries
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

48

primary outcome
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Adverse Event (AE);AEs;AEs;Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5;Serious adverse event (SAE) and adverse event of special interest (AESI)

Notes
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Oct. 20, 2022, 4 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2631, "treatment_name": "V-01-351+v-01-b5", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2632, "treatment_name": "V-01+v-01-b5", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2629, "treatment_name": "V-01", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]