NCT04863638

Brief Summary

This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules compared to that in population aged 18-59 years old with 2-dose schedule. And subjects in the same age are randomly assigned to different immunization schedule groups.

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
4,400

participants targeted

Target at P75+ for phase_4 covid19

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
unknown

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

April 27, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 29, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

April 27, 2021

Last Update Submit

June 15, 2023

Conditions

Covid19

Keywords

SARS-CoV-2SARS-CoV-2 VaccineCoronavirus

Outcome Measures

Primary Outcomes (2)

  • The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    Neutralizing antibody assay will be performed using the Microcytopathic assay

    14 days after the full course immunization

  • The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    ≥4 fold increase from baseline

    14 days after the full course immunization

Secondary Outcomes (7)

  • The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    14 days after the second dose in schedule of Day 0,21,42

  • The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    14 days after the second dose in schedule of Day 0,21,42

  • The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

    before the third dose in schedules of Day 0,21,111 and Day 0,21,171

  • The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody

    before the third dose in schedules of Day 0,21,111 and Day 0,21,171

  • Immune Persistence

    3 months, 6 months, 12 months after the full course immunization

  • +2 more secondary outcomes

Other Outcomes (1)

  • Immune Persistence

    18 months and 24 months after the full immunization

Study Arms (18)

A1 aged ≥ 71

EXPERIMENTAL

300 subjects age ≥ 71 （A1）receive 3 doses of vaccine

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

A2 aged ≥ 71

EXPERIMENTAL

200 subjects age ≥ 71 （A2）receive 3 doses of vaccine

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

A3 aged ≥ 71

EXPERIMENTAL

200 subjects age ≥ 71 (A3) receive 3 doses of vaccine

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

B1 aged 60-70

EXPERIMENTAL

300 subjects age 60-70 (B1) receive 3 doses of vaccine

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

B2 aged 60-70

EXPERIMENTAL

200 subjects age 60-70 (B2) receive 3 doses of vaccine

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

B3 aged 60-70

EXPERIMENTAL

200 subjects age 60-70 (B3) receive 3 doses of vaccine

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

C1 aged 18-59

EXPERIMENTAL

300 subjects age 18-59 (C1) receive 3 doses of vaccine

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

C2 aged 18-59

EXPERIMENTAL

200 subjects age 18-59 (C2) receive 3 doses of vaccine

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

C3 aged 18-59

EXPERIMENTAL

200 subjects age 18-59 (C3) receive 3 doses of vaccine

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

C4 aged 18-59

EXPERIMENTAL

300 subjects age 18-59 (C4) receive 2 doses of vaccine

Biological: 2 doses of vaccine

D1 aged 9-17

EXPERIMENTAL

300 subjects age 9-17 (D1) receive 3 doses of vaccine

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

D2 aged 9-17

EXPERIMENTAL

200 subjects age 9-17 (D2) receive 3 doses of vaccine

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

D3 aged 9-17

EXPERIMENTAL

200 subjects age 9-17 （D3）receive 3 doses of vaccine

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

D4 aged 9-17

EXPERIMENTAL

300 subjects age 9-17 （D4）receive 2 doses of vaccine

Biological: 2 doses of vaccine

E1 aged 3-8

EXPERIMENTAL

300 subjects age 3-8 （E1） receive 3 doses of vaccine

Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated

E2 aged 3-8

EXPERIMENTAL

200 subjects age 3-8 （E2）receive 3 doses of vaccine

Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated

E3 aged 3-8

EXPERIMENTAL

200 subjects age 3-8 （E3）receive 3 doses of vaccine

Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated

E4 aged 3-8

EXPERIMENTAL

300 subjects age 3-8 （E4）receive 2 doses of vaccine

Biological: 2 doses of vaccine

Interventions

3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), InactivatedBIOLOGICAL

the schedule of Day 0, 21, 42

A1 aged ≥ 71B1 aged 60-70C1 aged 18-59D1 aged 9-17E1 aged 3-8
3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), InactivatedBIOLOGICAL

the schedule of Day 0, 21, 111

A2 aged ≥ 71B2 aged 60-70C2 aged 18-59D2 aged 9-17E2 aged 3-8
3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), InactivatedBIOLOGICAL

the schedule of Day 0, 21, 171

A3 aged ≥ 71B3 aged 60-70C3 aged 18-59D3 aged 9-17E3 aged 3-8
2 doses of vaccineBIOLOGICAL

the schedule of Day 0, 21

C4 aged 18-59D4 aged 9-17E4 aged 3-8

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 3 years and above (after enrolled, subjects will be allocated according to age).
  • By asking for medical history and physical examination, the health condition judged by the investigators is well.
  • No vaccination history of COVID-19 vaccine before enrollment.
  • Be able and willing to complete the whole prescribed study plan.
  • With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

You may not qualify if:

  • Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check "China Disease Prevention and Control Information System").
  • Has a history of SARS, MERS infection (self-report, on-site inquiry).
  • \>14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃.
  • Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
  • With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
  • Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
  • Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
  • With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
  • Received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
  • Received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
  • Received blood products within 3 months before enrolment.
  • Received other research drugs within 6 months before enrolment.
  • Other circumstances judged by investigators are not suitable for this clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yanjin County Center for Disease Control and Prevention

Xinxiang, Henan, 453200, China

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Yanxia Wang, Bachelor

    Henan 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

April 27, 2021

First Posted

April 28, 2021

Study Start

April 29, 2021

Primary Completion

December 20, 2021

Study Completion

March 31, 2024

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

CN(1)