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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04992260
Recruitment Status : Active, not recruiting
First Posted : August 5, 2021
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Inactivated COVID-19 Vaccine Biological: Controlled vaccine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 10, 2021
Estimated Primary Completion Date : December 25, 2023
Estimated Study Completion Date : December 25, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group
7000 subjects (including 100 participants aged 6-35 months ,1900 participants aged 3-5 years ,2500 participants aged 6-11 years and 2500 aged 12-17 years )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 Name: CoronaVac
Placebo Comparator: Control Group
7000 subjects (including 100 participants aged 6-35 months ,1900 participants aged 3-5 years ,2500 participants aged 6-11 years and 2500 aged 12-17 years )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 Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04992260


Locations
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Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Study Director: Zeng Gang, Doctor Facultad de Medicina, Pontlficla Universidad Católica de Chile
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Soto JA, Melo-Gonzalez F, Gutierrez-Vera C, Schultz BM, Berrios-Rojas RV, Rivera-Perez D, Pina-Iturbe A, Hoppe-Elsholz G, Duarte LF, Vazquez Y, Moreno-Tapia D, Rios M, Palacios PA, Garcia-Betancourt R, Santibanez A, Pacheco GA, Mendez C, Andrade CA, Silva PH, Diethelm-Varela B, Astudillo P, Calvo M, Cardenas A, Gonzalez M, Goldsack M, Gutierrez V, Potin M, Schilling A, Tapia LI, Twele L, Villena R, Grifoni A, Sette A, Weiskopf D, Fasce RA, Fernandez J, Mora J, Ramirez E, Gaete-Argel A, Acevedo ML, Valiente-Echeverria F, Soto-Rifo R, Retamal-Diaz A, Munoz-Jofre N; PedCoronaVac03CL Study Group,; Meng X, Xin Q, Alarcon-Bustamante E, Gonzalez-Aramundiz JV, Le Corre N, Alvarez-Figueroa MJ, Gonzalez PA, Abarca K, Perret C, Carreno LJ, Bueno SM, Kalergis AM. Inactivated Vaccine-Induced SARS-CoV-2 Variant-Specific Immunity in Children. mBio. 2022 Dec 20;13(6):e0131122. doi: 10.1128/mbio.01311-22. Epub 2022 Nov 16.

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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04992260    
Other Study ID Numbers: PRO-nCOV-3002
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: January 12, 2023
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs