COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT05198336


Column Value
Trial registration number NCT05198336
Full text link
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05198336

First author
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Qing Xu

Contact
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

xqepi@163.com

Registration date
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

2022-01-20

Recruitment status
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Jan. 21, 2022, noon
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 : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

inclusion criteria: have received two doses of inactivated covid-19 vaccine(coronavac) manufactured by sinovac research & development co., ltd and is currently 28-42 days after the second dose; the subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form); the subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood; proven legal identity.

Exclusion criteria
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

haven't received two doses of inactivated covid-19 vaccine(coronavac); have received covid-19 vaccines from other manufacturers; the interval between blood collection and the second dose is less than 28 days or more than 42 days; the subjets and their legal guardians can't cooperate to complete 3ml venous blood collection. 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 : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

2

Funding
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Sinovac Research and Development Co., Ltd.

Inclusion age min
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

3

Inclusion age max
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

11

Countries
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

400

primary outcome
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2;Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2

Notes
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

None

Phase
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

Phase 4

Arms
Last imported at : Jan. 21, 2022, noon
Source : ClinicalTrials.gov

[{"arm_notes": "600SU;3-5 years old;third dose (28-42 days after the second dose Coronavac)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "600SU;6-11 years old;third dose (28-42 days after the second dose Coronavac)", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]