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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992260
• Other study ID #: PRO-nCOV-3002
• Status: Completed
• Phase: Phase 3
• Start date: September 10, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11349
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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
• 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.

Locations

Country	Name	City	State
Chile	Hospital Universidad Clinico de Antofagasta	Antofagasta	Metropolitana
Chile	Hospital Roberto del Río	Independencia	Metropolitana
Chile	Clínica San Carlos de Apoquindo	Las Condes	Metropolitana
Chile	Clínica Universidad de los Andes	Las Condes	Metropolitana
Chile	San Joaquín	Macul	Metropolitana
Chile	Hospital Sótero del Río	Puente Alto	Metropolitana
Chile	Hospital de Puerto Montt	Puerto Montt	Los Lagos
Chile	Hospital Ezequial Gonzalez	San Miguel	Metropolitana
Chile	Marcoleta	Santiago	Metropolitana
Chile	Clínica Alemana Valdivia	Valdivia	Los Ríos
Chile	Hospital Gustavo Fricke	Viña del Mar	Valparaíso
Chile	Clínica Alemana	Vitacura	Metropolitana
Malaysia	Hospital Pengajar UiTM Puncak Alam	Bandar	Selangor
Malaysia	Klinik Kesihatan Cheras Baru	Cheras	Kuala Lumpur
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Hospital Wanita dan Kanak-Kanak Sabah	Kota	Kinabalu Sabah
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Miri	Miri	Sarawak
Malaysia	Klinik Kesihatan Pandamaran	Pelabuhan Klang	Selangor
Malaysia	Hospital Seberang Jaya	Seberang Jaya	Pulau Pinang
Malaysia	Hospital Sibu	Sibu	Sarawak
Malaysia	Hospital Sungai Buloh	Sungai Buloh	Selangor
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	Asian Hospital and Medical Center	Muntinlupa
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	Mecru Clinical Research Unit	Ga-Rankuwa	Gauteng
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

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Countries where clinical trial is conducted

Chile,  Malaysia,  Philippines,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset	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	Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset	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
Secondary	Efficacy index-incidence of RT-PCR confirmed, symptomatic COVID-19 cases with onset in SARS-CoV-2 uninfected participants	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
Secondary	Efficacy index-incidence of hospitalization/severe/death caused by COVID-19 with onset	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
Secondary	Safety index-occurrence, intensity, duration, and relationship of solicited local and systemic AEs and of unsolicited AEs	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
Secondary	Safety index-occurrence and relationship of SAEs	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
Secondary	Safety index-occurrence and relationship of AESI	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
Secondary	Immunogenicity index(subgroup)-SARS-CoV-2 neutralizing antibody titers	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
Secondary	Immunogenicity index(subgroup)-Anti-SARS-CoV-2 S	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