Safety Study of COVID19 Vaccine on the Market

June 2, 2023 updated by: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Multi-center Safety Observation of COVID19 Vaccine in a Large Population

Popular topic:Multi-center safety observation of recombinant Novel Coronavirus protein vaccine (CHO cells) in a large population Study population:People aged 18 and above

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Overall design:The aim of this study is to carry out safety studies in the large scale healthy population and special population of recombinant New Coronavirus protein vaccine (CHO cell) in China. It will be included in 100 thousand subjects, including 20 thousand special populations. It is planned to enroll 50000 cases in Hunan (including no less than 10000 special people), 40000 cases in Guizhou (including no less than 8000 special people), and 10000 cases in Hainan (including no less than 2000 special people).

Special groups include but are not limited to obesity, chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc. If the researcher determines that it is necessary, the special population shall provide the medical diagnosis certificate or the drug prescription certificate issued by the doctor.

Immunization program: Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person.

Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.

Follow up and record:

  1. Passive monitoring:

    After all subjects have been vaccinated, the researcher shall conduct safety education and issue contact cards to the subjects, so that the subjects can contact the researcher in time in case of any discomfort. The researcher shall timely standardize the treatment and collect the AESI or SAE information of the subjects.

  2. Active monitoring:

All subjects installed customized APP or Wechat applet through mobile phones on the first 7 days and 30 days after each dose of vaccination, and 3, 6, 9 and 12 months after the last dose of vaccination, and recorded and collected the occurrence of adverse events: ① the first dose of vaccination - 30 days after the whole dose of vaccination, and 30 days after the enhanced vaccination, including the occurrence of all adverse events, including solicited AE (vaccination site (local adverse events) Non inoculated sites (systemic adverse events)) and non solicited AEs; ② First dose - SAE, AESI and pregnancy events within 12 months after full vaccination and 12 months after booster immunization.

The solicitation AE is:

Adverse events at the inoculation site (local): pain, pruritus, erythema, swelling, rash and induration; Non inoculated site (systemic) adverse events: fever, headache, fatigue / fatigue, diarrhea, nausea, vomiting, muscle pain (non inoculated site), acute allergic reaction and cough.

Safety assessment:

AE, AESI and SAE:

  1. Collect adverse events of special concern (AESI) from the first dose of vaccination to one year after the whole course of vaccination and one year after intensive immunization, including myocarditis / pericarditis, thrombosis, thrombocytopenia, immune related diseases (psoriasis, rheumatoid arthritis, etc.), nervous system related diseases (glibali syndrome, peripheral neuropathy, bell facial paralysis);
  2. Collect serious adverse events (SAE) from the first dose of vaccination to 1 year after the whole course of vaccination and 1 year after intensive immunization;
  3. Collect all AEs from the first dose to 30 days after the whole course of vaccination and 30 days after booster immunization.

Pregnancy events:

The pregnancy events from the first dose of vaccination to one year after the whole course of vaccination and one year after the booster vaccination were collected (at the same time, the safety and pregnancy outcome of pregnant women's accidental vaccination were analyzed).

ADE/ VED risk monitoring:

After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with SARS-COV-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. For confirmed cases, detailed case investigation shall be carried out. In case of aggregated new coronavirus infection or severe, critical and death cases after sars-cov-2 infection during the trial, special investigation shall be carried out. According to the analysis of special investigation results, if there is ADE/ VED phenomenon, an expert meeting shall be held to evaluate whether there is ADE / VED risk.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 411228
        • Recruiting
        • Hunan Provincial Center for Disease Control and Prevention
        • Contact:
          • Lidong Gao
          • Phone Number: 0731-84305911

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Healthy people or special people aged 18 and above who meet the requirements of national new coronavirus vaccination (including but not limited to obesity (BMI ≥ 28kg/ m²). Chronic metabolic diseases, chronic lung diseases, chronic cardiovascular diseases, tumors, acquired immunodeficiency syndrome, chronic kidney disease, etc.); If the researcher determines that it is necessary, the special population shall provide relevant written diagnosis certificates, records or drug prescription certificates issued by doctors;
  2. The subjects voluntarily participated in the study, signed the informed consent, understood and complied with the requirements of the clinical trial scheme, and were able to understand the research procedures.

Exclusion Criteria:

  1. Patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled bleeding and coagulation diseases, etc;
  2. People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
  3. Patients suffering from acute disease, or acute attack of chronic disease, or uncontrolled severe chronic disease;
  4. Previous history of severe allergy to any vaccine or any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, Henoch Schonlein purpura, thrombocytopenic purpura, dyspnea, angioneuroedema, etc;
  5. The researchers believe that the subject has any disease or condition that may put the subject at unacceptable risk; The subjects could not meet the protocol requirements; Interference with the evaluation of vaccine response.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Population Ⅰ
Biological: Recombinant new coronavirus vaccine (CHO cell)

Subjects who have not received any Novel Coronavirus vaccine or the full dose of recombinant Novel Coronavirus protein vaccine (CHO cells) shall receive 3 doses of the experimental vaccine intramuscular in the deltoid muscle of the upper arm or complete the remaining doses of the experimental vaccine as per the vaccination schedule at 0, 1, and 2 months, with a dose of 0.5ml for each person.

Immunized subjects: intramuscular injection of one dose of the experimental vaccine into the deltoid muscle of the upper arm, 0.5ml for each person.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SAE
Time Frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Serious adverse events (SAE) were collected from the first dose to 1 year after full vaccination and 1 year after booster immunization.
The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
AE
Time Frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
All AE from the first dose to 30 days after full vaccination and 30 days after booster immunization were collected.
The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
AESI
Time Frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
Adverse events of special Interest (AESI) analysis 12 months after first dose-full dose and 12 months after booster dose: incidence of adverse events of special interest
The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ADE/VED
Time Frame: The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose
After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with sars-cov-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. For confirmed cases, detailed case investigation shall be carried out. In case of aggregated new coronavirus infection or severe, critical and death cases after sars-cov-2 infection during the trial, special investigation shall be carried out. According to the analysis of special investigation results, if there is ADE / VED phenomenon, an expert meeting shall be held to evaluate whether there is ADD/ VED risk.
The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hunan Provincial Center for Disease Control and Prevention
Guizhou Center for Disease Control and Prevention
Hainan Center for Disease Control & Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Lidong Gao, Hunan Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 16, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LKM-2022-NCV-PM01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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