Efficacy, Immunogenicity and Safety of COVID-19 Vaccine , Inactivated in Children and Adolescents

October 12, 2023 updated by: Sinovac Research and Development Co., Ltd.

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine(Vero Cell) ,Inactivated in Children and Adolescents Aged 6 Months to 17 Years

This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.

Study Overview

Status

Status

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

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

This study is a global multi-center , case-driven, randomized, double-blinded, and placebo-controlled phase Ⅲ clinical trial in participants aged 6 months to 17 years.The purpose of this study is to evaluate the efficacy of two dose of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 6 months to 17 years.The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 14,000 healthy participants aged 6 months to 17 years will be enrolled, and randomly assigned into 2 groups at a ratio of 1:1 to receive 2 doses of experimental vaccine (600SU) or placebo with an interval of 28 days.

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 (Actual)

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.
11349

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 3

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

  • Chile
    • Los Lagos
      • Puerto Montt, Los Lagos, Chile
        • Hospital De Puerto Montt
    • Los Ríos
      • Valdivia, Los Ríos, Chile
        • Clínica Alemana Valdivia
    • Metropolitana
      • Antofagasta, Metropolitana, Chile
        • Hospital Universidad Clinico de Antofagasta
      • Independencia, Metropolitana, Chile
        • Hospital Roberto del Rio
      • Las Condes, Metropolitana, Chile
        • Clínica San Carlos de Apoquindo
      • Las Condes, Metropolitana, Chile
        • Clínica Universidad de los Andes
      • Macul, Metropolitana, Chile
        • San Joaquín
      • Puente Alto, Metropolitana, Chile
        • Hospital Sotero Del Rio
      • San Miguel, Metropolitana, Chile
        • Hospital Ezequial Gonzalez
      • Santiago, Metropolitana, Chile
        • Marcoleta
      • Vitacura, Metropolitana, Chile
        • Clinica Alemana
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile
        • Hospital Gustavo Fricke
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Kinabalu Sabah
      • Kota, Kinabalu Sabah, Malaysia, 88996
        • Hospital Wanita dan Kanak-Kanak Sabah
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56100
        • Klinik Kesihatan Cheras Baru
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Hospital Raja Permaisuri Bainun
    • Pulau Pinang
      • Seberang Jaya, Pulau Pinang, Malaysia, 13700
        • Hospital Seberang Jaya
    • Sarawak
      • Miri, Sarawak, Malaysia, 980000
        • Hospital Miri
      • Sibu, Sarawak, Malaysia, 96000
        • Hospital Sibu
    • Selangor
      • Bandar, Selangor, Malaysia, 42300
        • Hospital Pengajar UiTM Puncak Alam
      • Pelabuhan Klang, Selangor, Malaysia, 42000
        • Klinik Kesihatan Pandamaran
      • Sungai Buloh, Selangor, Malaysia, 47000
        • Hospital Sungai Buloh
  • Philippines
      • Manila, Philippines
        • Philippine General Hospital
      • Manila, Philippines
        • National Children's Hospital
      • Manila, Philippines
        • Philippine Children's Medical Center
      • Manila, Philippines
        • University of Philippines, National Institute of Health
      • Muntinlupa, Philippines
        • Asian Hospital and Medical Center
  • South Africa
      • Bellville, South Africa, 0204
        • MeCRU Clinical Research Unit
      • Bellville, South Africa, 7530
        • Tiervlei Trial Centre
      • Benoni,, South Africa, 1501
        • Worthwhile Clinical Trials
      • Boksburg, South Africa
        • Reimed Reicherpark
      • Johannesburg, South Africa, 2113
        • Newtown Clinical Research Centre
      • Madibeng, South Africa, 0250
        • Madibeng Centre for Research
      • Paarl, South Africa, 7626
        • Be Part Research
      • Pretoria, South Africa, 0083
        • Global Clinical Trials
      • Sandton, South Africa, 2196
        • Sandton Medical Research Centre
      • Soweto, South Africa, 1459
        • Soweto Clinical Trials Center
    • Gauteng
      • Ga-Rankuwa, Gauteng, South Africa, 1818
        • MeCRU Clinical Research Unit

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

6 months to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy children and adolescents aged 6 months to 17 years;
  • The participants and/or their guardians are able to understand and sign the informed consent voluntarily (in accordance with the local regulations);
  • Able to comply with study procedures based on the assessment of the Investigator;

  • Female participants of childbearing potential (post-menarche girls or in accordance with the local standard of care) may be enrolled in the study if the participant fulfills all the following criteria:

    • Has a negative pregnancy test on the day of the first dose (Day 0).
    • Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 0).
    • Has agreed to continue adequate contraception through 3 months following the second dose (Day 28).
    • Is not currently breastfeeding.
  • 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.

Exclusion Criteria:

  • History of confirmed infection of SARS CoV-2 prior to randomization;
  • 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;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc;
  • Acute febrile illness with oral temperature >37.7°C or axillary temperature >37.5°C on the day of vaccination (refer to section 7.1 Delay/Discontinuation of Study Vaccination); enrollment could be considered if the fever is absent for 72 hours;
  • Any confirmed or suspected human immunodeficiency virus (HIV) infection;
  • Children in care or under a court order;
  • According to the investigator's judgment, the subject has any other factors that might interfere with the results of the clinical trial or pose additional risk to the subject due to participation in the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Experimental Group
subjects will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28.
Biological: Inactivated COVID-19 Vaccine
The inactivated COVID-19 vaccine was manufactured by Sinovac Research& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection
Other Names:
  • CoronaVac
Placebo Comparator: Control Group
subjects will receive two doses of placebo on day 0 and day 28.
Biological: Controlled vaccine
The placebo was manufactured by Sinovac Research& Development Co., Ltd.The composition is aluminium hydroxide,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.
Other Names:
  • Placebo

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
Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset
Time Frame: 14 days after the second dose
Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the second dose
14 days after the second 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
Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset
Time Frame: 14 days after the first dose
Incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset at least 14 days after the first dose
14 days after the first dose
Efficacy index-incidence of RT-PCR confirmed, symptomatic COVID-19 cases with onset in SARS-CoV-2 uninfected participants
Time Frame: 14 days after the second dose
Incidence of RT-PCR confirmed, symptomatic COVID-19 with onset at least 14 days after the second dose in SARS-CoV-2 uninfected (serologically or molecularly confirmed) participants at baseline
14 days after the second dose
Efficacy index-incidence of hospitalization/severe/death caused by COVID-19 with onset
Time Frame: 14 days after the second dose
Incidence of hospitalization/severe/death caused by COVID-19 with onset at least 14 days after the second dose
14 days after the second dose
Safety index-occurrence, intensity, duration, and relationship of solicited local and systemic AEs and of unsolicited AEs
Time Frame: During 7 days following each dose vaccination and during 28 days post-vaccination
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs during 7 days following each dose vaccination and of unsolicited AEs during 28 days post-vaccination
During 7 days following each dose vaccination and during 28 days post-vaccination
Safety index-occurrence and relationship of SAEs
Time Frame: From first dose to 12 months after the last dose
Occurrence and relationship of SAEs from first dose to 12 months after the last dose
From first dose to 12 months after the last dose
Safety index-occurrence and relationship of AESI
Time Frame: From first dose to 12 months after the last dose
Occurrence and relationship of AESI from first dose to 12 months after the last dose
From first dose to 12 months after the last dose
Immunogenicity index(subgroup)-SARS-CoV-2 neutralizing antibody titers
Time Frame: From first dose to 12 months after the last dose
Analysis of SARS-CoV-2 neutralizing antibody titers by micro-cytopathic method to compare with the placebo group
From first dose to 12 months after the last dose
Immunogenicity index(subgroup)-Anti-SARS-CoV-2 S
Time Frame: From first dose to 12 months after the last dose
Analysis of Anti-SARS-CoV-2 S by electrochemiluminescence immunoassay to compare with the placebo group
From first dose to 12 months after 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.
Sinovac Research and Development Co., Ltd.

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 Director: Zeng Gang, Doctor, Facultad de Medicina, Pontlficla Universidad Católica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 10, 2021

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.
May 31, 2023

Study Completion (Actual)

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.
May 31, 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).
August 3, 2021

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.
August 3, 2021

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.
August 5, 2021

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.
October 16, 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.
October 12, 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.
October 1, 2023

More Information

Terms related to this study

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.
  • PRO-nCOV-3002

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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