Safety retrospective and immunogenicity study of novel coronavirus inactivated vaccine (Vero cells) in people with underlying diseases

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200058281

Enrollment

Unknown

Registered

2022-04-04

Start date

2021-07-15

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases caused by SARS-CoV-2 infection (COVID-19)

Interventions

Coronary heart disease (40-59 years old) group:None

Acute coronary disease (>=60 years old) group:None

Hypertension (40-59 years old) group:None

Hypertension (>= 60 years old) group:None

Diabetes mellitus (40-59 years old) group:None

Diabetes mellitus (>=60 years) group:None

Chronic respiratory disease (40-59 years old) group:None

Chronic respiratory disease (>=60 years old) group:None

Obese (40-59 years old) group:None

Obese (>=60 years old) group:None

Cancer (40-59 years old) group:None

Cancer (>=60 years old) group:None

Healthy population (CoronaVac -- BBIBP-CorV, 40-59 years old) group:None

Healthy population (CoronaVac -- BBIBP-CorV, >=60 years old) group:None

Healthy population (BBIBP-CorV--CoronaVac, 40-59 years old) group:None

Healthy population (BBIBP-CorV--CoronaVac, >=60 years old) group:None

Healthy population(CoronaVac--CoronaVac, 40-59 years old) group:None

Healthy population(CoronaVac--CoronaVac, >=60 years old) group:None

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged over 40 years, healthy or suffering from the following common diseases: coronary heart disease, hypertension, diabetes, chronic respiratory disease, obesity and tumor; 2. Two doses of COVID-19 vaccine have been given recently, with an interval of 3-5 weeks, at least one of which is produced by Sinovac Medium Vitamin; 3. 14-28 days after the second dose; 4. Subjects can complete the study process according to the researcher's guidance.

Exclusion criteria

Exclusion criteria: 1. A history of infection with the novel coronavirus; 2. History of other novel coronavirus vaccines; 3. Patients with serious mental and neurological diseases; 4. In the investigator's judgment, the patient has any other ineligible factors for clinical trial participation.

Design outcomes

Primary

Measure	Time frame
Neutralizing antibody titers;	—

Secondary

Measure	Time frame
COVID-19 specific T cell;Incidence of adverse events;Serious adverse events and adverse event rates of special concern;Durability of SARS-CoV-2-specific antibody titers;	—

Countries

China

Contacts

Public ContactZhang Zijie

Yunnan University

zijiezhang@ynu.edu.cn+86 18608716699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026