NCT04953325

Brief Summary

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for phase_4 covid19

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

July 9, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 14, 2022

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 5, 2021

Last Update Submit

April 12, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate of the neutralizing antibody to SARS-CoV-2

    Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at day 28 after the second dose of inactivated COVID-19 vaccine

    Day 28 after the second dose

Secondary Outcomes (11)

  • Seroconversion rate of the neutralizing antibody to SARS-CoV-2

    Day 4, 14, 32,42 and 56 after the first dose

  • Seropositivity rate of the neutralizing antibody to SARS-CoV-2

    Day 4, 14, 28, 32,42 and 56 after the first dose

  • GMT of the neutralizing antibody to SARS-CoV-2

    Day 4, 14, 28, 32,42 and 56 after the first dose

  • GMI of the neutralizing antibody to SARS-CoV-2

    Day 4, 14, 28, 32,42 and 56 after the first dose

  • Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA)

    Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine

  • +6 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

180 subjects (including 90 adults aged 18-59 years and 90 elderly aged 60 year and older）will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28

Biological: Inactivated COVID-19 Vaccine

Control Group

PLACEBO COMPARATOR

90 subjects (including 45 adults aged 18-59 years and 45 elderly aged 60 year and older）will receive one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28

Biological: 23-valent pneumococcal polysaccharide vaccineBiological: Inactivated Hepatitis A Vaccine

Interventions

Inactivated COVID-19 VaccineBIOLOGICAL

600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

Also known as: CoronaVac
Experimental Group
23-valent pneumococcal polysaccharide vaccineBIOLOGICAL

25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F

Control Group
Inactivated Hepatitis A VaccineBIOLOGICAL

500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy population aged 18 years and above;
  • The subjects can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

You may not qualify if:

  • History of SARS-CoV-2 infection;
  • Have received any COVID-19 vaccine;
  • Participants with abnormal fasting blood glucose or diabetes;
  • 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;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Diseases or factors that are prone to thrombosis or bleeding, such as thrombophlebitis, major surgery/trauma, hereditary thrombotic disorder, sepsis, inflammatory bowel disease, severe varicose veins, May-Thurner syndrome, fibrinolytic activity enhancement disease, history of cardiac stent surgery, allergic purpura, etc.;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • Abnormal hematological laboratory test results outside the reference range during previous physical examination within one year: Blood routine indicators (white blood cell count, hemoglobin, platelet count), Coagulation function test (prothrombin time PT, activated partial prothrombin time APTT, fibrinogen FIB, thrombin time TT, international standardized ratio INR, D-dimer), other indicators (blood glucose, platelet factor 4 HIT ELISA, erythrocyte sedimentation rate);
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rushan City Center for Disease Control and Prevention

Weihai, Shandong, 250014, China

Location

Related Publications (1)

  • Xu Q, Lu X, Liu X, Zhao Y, Sun D, Cao Q, Liu H, Yang T, Song Y, Lv J, Xiong P, Li J, Sun J, Xie M, Gao Y, Zhang L. Effect of an inactivated coronavirus disease 2019 vaccine, CoronaVac, on blood coagulation and glucose: a randomized, controlled, open-label phase IV clinical trial. Front Immunol. 2023 May 31;14:1122651. doi: 10.3389/fimmu.2023.1122651. eCollection 2023.

    PMID: 37325662DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Li Zhang, Master

    Shandong Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 7, 2021

Study Start

July 9, 2021

Primary Completion

October 31, 2021

Study Completion

January 31, 2022

Last Updated

April 14, 2022

Record last verified: 2021-07

Locations

CN(1)