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

NCT ID: NCT04992260

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2023-05-31

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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

subjects will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28.

Group Type: EXPERIMENTAL

Inactivated COVID-19 Vaccine

Intervention Type: BIOLOGICAL

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

Control Group

subjects will receive two doses of placebo on day 0 and day 28.

Group Type: PLACEBO_COMPARATOR

Controlled vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

CoronaVac; Placebo

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Research and Development Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zeng Gang, Doctor

Role: STUDY_DIRECTOR

Facultad de Medicina, Pontlficla Universidad Católica de Chile

Locations

Hospital de Puerto Montt

Port Montt, Los Lagos Region, Chile

Clínica Alemana Valdivia

Valdivia, Los Ríos Region, Chile

Hospital Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

Hospital Universidad Clinico de Antofagasta

Antofagasta, Santiago Metropolitan, Chile

Hospital Roberto del Río

Independencia, Santiago Metropolitan, Chile

Clínica San Carlos de Apoquindo

Las Condes, Santiago Metropolitan, Chile

Clínica Universidad de los Andes

Las Condes, Santiago Metropolitan, Chile

San Joaquín

Macul, Santiago Metropolitan, Chile

Hospital Sótero del Río

Puente Alto, Santiago Metropolitan, Chile

Hospital Ezequial Gonzalez

San Miguel, Santiago Metropolitan, Chile

Marcoleta

Santiago, Santiago Metropolitan, Chile

Clínica Alemana

Vitacura, Santiago Metropolitan, Chile

Hospital Wanita dan Kanak-Kanak Sabah

Kota, Kinabalu Sabah, Malaysia

Klinik Kesihatan Cheras Baru

Cheras, Kuala Lumpur, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, Malaysia

Hospital Miri

Miri, Sarawak, Malaysia

Hospital Sibu

Sibu, Sarawak, Malaysia

Hospital Pengajar UiTM Puncak Alam

Bandar, Selangor, Malaysia

Klinik Kesihatan Pandamaran

Port Klang, Selangor, Malaysia

Hospital Sungai Buloh

Sungai Buloh, Selangor, Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Asian Hospital and Medical Center

City of Muntinlupa, , Philippines

National Children's Hospital

Manila, , Philippines

Philippine Children's Medical Center

Manila, , Philippines

Philippine General Hospital

Manila, , Philippines

University of Philippines, National Institute of Health

Manila, , Philippines

Mecru Clinical Research Unit

Ga-Rankuwa, Gauteng, South Africa

Mecru Clinical Research Unit

Bellville, , South Africa

Tiervlei Trial Centre

Bellville, , South Africa

Worthwhile Clinical Trials

Benoni, , South Africa

Reimed Reicherpark

Boksburg, , South Africa

Newtown Clinical Research Centre

Johannesburg, , South Africa

Madibeng Centre for Research

Madibeng, , South Africa

Be Part Research

Paarl, , South Africa

Global Clinical Trials

Pretoria, , South Africa

Sandton Medical Research Centre

Sandton, , South Africa

Soweto Clinical Trials Center

Soweto, , South Africa

Countries

Chile; Malaysia; Philippines; South Africa

References

Rivera-Perez D, Mendez C, Diethelm-Varela B, Melo-Gonzalez F, Vazquez Y, Meng X, Xin Q, Fasce RA, Fernandez J, Mora J, Ramirez E, Acevedo ML, Valiente-Echeverria F, Soto-Rifo R, Grifoni A, Weiskopf D, Sette A, Astudillo P, Le Corre N, Abarca K, Perret C, Gonzalez PA, Soto JA, Bueno SM, Kalergis AM. Immune responses during COVID-19 breakthrough cases in vaccinated children and adolescents. Front Immunol. 2024 May 15;15:1372193. doi: 10.3389/fimmu.2024.1372193. eCollection 2024.

Reference Type: DERIVED

PMID: 38812507 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36383021 (View on PubMed)

Other Identifiers

PRO-nCOV-3002

Identifier Type: -

Identifier Source: org_study_id