Safety Study of COVID19 Vaccine on the Market

NCT05890521 | Unknown Phase 4

• 1 other identifier: LKM-2022-NCV-PM01
• Study Type: interventional
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

Recombinant Novel Coronavirus Vaccine

Outcome Measures

Primary Outcomes (3)

• SAE

  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

  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

  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 Outcomes (1)

• ADE/VED

  The period from receipt of the first dose of vaccine to 1 year after receipt of the last dose

Study Arms (1)

Population Ⅰ

EXPERIMENTAL

Biological: Recombinant new coronavirus vaccine (CHO cell)

Interventions

Recombinant new coronavirus vaccine (CHO cell) BIOLOGICAL

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.

Population Ⅰ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• Patients with uncontrolled lymphoproliferative diseases, unresponsive aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled bleeding and coagulation diseases, etc;
• People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating disease, etc.);
• Patients suffering from acute disease, or acute attack of chronic disease, or uncontrolled severe chronic disease;
• 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;
• 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.

Sponsors & Collaborators

• Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.: lead
• Hunan Provincial Center for Disease Control and Prevention: collaborator
• Guizhou Center for Disease Control and Prevention: collaborator
• Hainan Center for Disease Control & Prevention: collaborator

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 411228, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lidong Gao

  Hunan Provincial Center for Disease Control and Prevention

  STUDY CHAIR

Central Study Contacts

Lidong Gao

CONTACT

0731-84305911; 810173358@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: June 6, 2023
• Study Start: April 2, 2022
• Primary Completion: June 16, 2022
• Study Completion: June 1, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

CN (1)