NCT05065892

Brief Summary

To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,440

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

September 28, 2021

Last Update Submit

October 16, 2021

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (2)

  • Seroconversion rate

    the rate of positive seroconversion against coronavirus

    Up to 28 days after the second dose

  • Neutralizing antibody level

    neutralizing antibody level against coronavirus

    Up to 28 days after the second dose

Secondary Outcomes (1)

  • Adverse events following vaccination

    up to 6 months

Study Arms (4)

Hypertension group

EXPERIMENTAL

Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older).

Biological: COVAX

Diabetes Mellitus group

EXPERIMENTAL

Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older).

Biological: COVAX

Combined Disease group

EXPERIMENTAL

Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older).

Biological: COVAX

Healthy people group

ACTIVE COMPARATOR

Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older).

Biological: COVAX

Interventions

COVAXBIOLOGICAL

2 doses of Covid-19 vaccine

Combined Disease groupDiabetes Mellitus groupHealthy people groupHypertension group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥60 years old individuals with full civil capacity.
  • Clinically confirmed body temperature of \<37.3°C before enrolling in this study.
  • Able and willing to participate in the study plan during the entire study and follow-up period.
  • Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol.

You may not qualify if:

  • Previously confirmed or asymptomatic COVID-19 patient.
  • Has been immunized with a SARS-CoV-2 vaccine.
  • Illiterate.
  • Known allergy to any ingredient (including excipient) of this product.
  • Received non-specific immunoglobulin injection within 1 month before enrollment.
  • Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization.
  • Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea).
  • Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome.
  • Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases.
  • Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
  • Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated.
  • Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications.
  • Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nan'an Center for Disease Control and Prevention

Quanzhou, Fujian, China

Location

Songtao Miao Autonomous County Center for Disease Control and Prevention

Tongren, Guizhou, China

Location

You County Center for Disease Control and Prevention

Zhuzhou, Hunan, China

Location

Central Study Contacts

Ruizhi ZHANG

CONTACT

+86-13985441115919987774@qq.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Serum testing technicians will be masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 4, 2021

Study Start

October 1, 2021

Primary Completion

January 1, 2022

Study Completion

March 1, 2022

Last Updated

October 25, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)