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Trial - NCT05329038


Column Value
Trial registration number NCT05329038
Full text link
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05329038

First author
Last imported at : July 15, 2022, 2:30 a.m.
Source : ClinicalTrials.gov

Li Zhang

Contact
Last imported at : July 15, 2022, 2:30 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

2022-04-14

Recruitment status
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: participated in the clinical studies on the safety and immunogenicity of inactivated covid-19 vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in rushan city, shandong province from july to october 2021; the interval between complete immunization with two doses of covid-19 vaccine is 6-8 months; subjects will be willing to participate in the study and follow the study procedure to collect venous blood; proven legal identity;

Exclusion criteria
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

history of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema; severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease; pregnancy or lactation; receipt of attenuated live vaccines in the past 14 days; receipt of inactivated or subunit vaccines in the past 7 days according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Number of arms
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : July 15, 2022, 2:30 a.m.
Source : ClinicalTrials.gov

Sinovac Life Sciences Co., Ltd.

Inclusion age min
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

180

primary outcome
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2

Notes
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : April 15, 2022, 11:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Adult group\n90 subjects aged 18-59 years", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Elderly group\n90 elderly aged 60", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]