Safety and Immunogenicity of COVID-19 Vaccine, Inactivated in Healthy Population Aged From 3 to 11 Years

NCT05137418 | Completed Phase 3

• 1 other identifier: PRO-nCOV-3002-1
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-labelled, bridging phase Ⅲ clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The main purpose of this study is to evaluate the superiority of the COVID-19 Vaccine in healthy population aged from 3 to 11 years against that in adults aged 18-26 years.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Immunogenicity index-the GMT of neutralizing antibodies

  The GMT of neutralizing antibodies 28 days after the second vaccination.

  28 days after the second vaccination

Secondary Outcomes (14)

• Immunogenicity index-the seroconversion rate of neutralizing antibodies

  28 days after the second vaccination

• Immunogenicity index-the seropositive rate of neutralizing antibodies 28 days after the second vaccination

  28 days after the second vaccination

• Immunogenicity index-GMI of neutralizing antibodies

  28 days after the second vaccination

• Immunogenicity index-The seroconversion rate of the S antibody to SARS-CoV-2

  28 days after the second vaccination

• Immunogenicity index-The seropositivity rate of the S antibody to SARS-CoV-2

  28 days after the second vaccination

Study Arms (2)

3-5 years old age group

EXPERIMENTAL

500 participants aged 3-5 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28.

Biological: COVID-19 Vaccine,Inactivated

6-11 years old age group

EXPERIMENTAL

500 participants aged 6-11 years will receive two doses of COVID-19 vaccine,inactivated on day 0 and day 28.

Biological: COVID-19 Vaccine,Inactivated

Interventions

COVID-19 Vaccine,Inactivated BIOLOGICAL

The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection

Also known as: CoronaVac

3-5 years old age group; 6-11 years old age group

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy participants aged 3-11 years;
• The participants and/or their guardians are able to understand and sign the informed consent voluntarily (in accordance with the local regulations)(For subjects aged 3-7years ,guardians need to sign the informed consent form,for subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form);
• Able to comply with study procedures based on the assessment of the Investigator
• Must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

You may not qualify if:

• History of SARS-CoV-2 infection;
• Close contact with a confirmed COVID-19 within 14 days prior to randomization;
• Prior administration of an investigational coronavirus vaccine or current/ planned simultaneous participation in another interventional study to prevent or treat COVID-19;
• Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
• Personal or first-grade relative (siblings) history of multisystem inflammatory disease in children (MIS-C);
• Significant chronic illnesses that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but are not limited to cardiovascular disease, liver or kidney disorders, respiratory illnesses);
• Significant chronic central nervous system diseases or neuromuscular disorders, psychosis or severe cognitive behavioral disorder, in the opinion of the investigator, including epilepsy, autism spectrum disorder, intellectual disabilities (excluding Down Syndrome);
• Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
• History of autoimmune and/or haematological diseases (including but not limited to systemic lupus erythematosus, thyroidectomy, autoimmune thyroid disease, any form of malignant tumor, asplenia, functional asplenia, or splenectomy resulting from any condition); well controlled type I diabetes mellitus is allowed;
• History of bleeding disorders (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture;
• Immunosuppressive therapy (systemic corticoid therapy, e.g. prednisone
• ≥2 mg/Kg/d or ≥20 mg/day for \>14 days), cytotoxic therapy (antineoplastic chemotherapy, radiation therapy), (excluding topical or aerosol corticosteroid therapy) in the past 6 months;
• Receipt of blood products or immunoglobulins in the past 3 months;
• Receipt of other investigational drugs in the past 30 days;
• Receipt of attenuated live vaccines in the past 14 days;

Sponsors & Collaborators

• Sinovac Research and Development Co., Ltd.: lead

Study Sites (1)

Sheyang County Center for Disease Control and Prevention

Yancheng, Jiangsu, 224300, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines; sinovac COVID-19 vaccine

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Hongxing Pan, Master

  Jiangsu Provincial Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: November 30, 2021
• Study Start: November 27, 2021
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

CN (1)