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COVID-19Phase 3NCT04992260

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

A Phase 3 study testing Inactivated COVID-19 Vaccine in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 38 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Inactivated COVID-19 Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11,349 participants
Where
38 sitesin 4 countries
Study dates
10 Sep 2021to 31 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

38 sites in 4 countries.

38 sites in 4 countries

Chile12 sites

  • Hospital Universidad Clinico de Antofagasta

    Antofagasta, Santiago Metropolitan

  • Hospital Roberto del Río

    Independencia, Santiago Metropolitan

  • Clínica San Carlos de Apoquindo

    Las Condes, Santiago Metropolitan

  • Clínica Universidad de los Andes

    Las Condes, Santiago Metropolitan

  • San Joaquín

    Macul, Santiago Metropolitan

  • Hospital de Puerto Montt

    Port Montt, Los Lagos Region

  • Hospital Sótero del Río

    Puente Alto, Santiago Metropolitan

  • Hospital Ezequial Gonzalez

    San Miguel, Santiago Metropolitan

  • Marcoleta

    Santiago, Santiago Metropolitan

  • Clínica Alemana Valdivia

    Valdivia, Los Ríos Region

  • Hospital Gustavo Fricke

    Viña del Mar, Valparaiso

  • Clínica Alemana

    Vitacura, Santiago Metropolitan

Other trials in Chile

South Africa11 sites

  • Mecru Clinical Research Unit

    Bellville, 0204

  • Tiervlei Trial Centre

    Bellville, 7530

  • Worthwhile Clinical Trials

    Benoni, 1501

  • Reimed Reicherpark

    Boksburg

  • Mecru Clinical Research Unit

    Ga-Rankuwa, Gauteng, 1818

  • Newtown Clinical Research Centre

    Johannesburg, 2113

  • Madibeng Centre for Research

    Madibeng, 0250

  • Be Part Research

    Paarl, 7626

  • Global Clinical Trials

    Pretoria, 0083

  • Sandton Medical Research Centre

    Sandton, 2196

  • Soweto Clinical Trials Center

    Soweto, 1459

Other trials in South Africa

Malaysia10 sites

  • Hospital Pengajar UiTM Puncak Alam

    Bandar, Selangor, 42300

  • Klinik Kesihatan Cheras Baru

    Cheras, Kuala Lumpur, 56100

  • Hospital Raja Permaisuri Bainun

    Ipoh, Perak, 30450

  • Hospital Wanita dan Kanak-Kanak Sabah

    Kota, Kinabalu Sabah, 88996

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Miri

    Miri, Sarawak, 980000

  • Klinik Kesihatan Pandamaran

    Port Klang, Selangor, 42000

  • Hospital Seberang Jaya

    Seberang Jaya, Pulau Pinang, 13700

  • Hospital Sibu

    Sibu, Sarawak, 96000

  • Hospital Sungai Buloh

    Sungai Buloh, Selangor, 47000

Other trials in Malaysia

Philippines5 sites

  • Asian Hospital and Medical Center

    City of Muntinlupa

  • National Children's Hospital

    Manila

  • Philippine Children's Medical Center

    Manila

  • Philippine General Hospital

    Manila

  • University of Philippines, National Institute of Health

    Manila

Other trials in Philippines

About this study

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

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.

Read the 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
Being tested
Inactivated COVID-19 Vaccine, Controlled vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inactivated COVID-19 VaccineBiological

    Also called CoronaVac

    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 vaccineBiological

    Also called Placebo

    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.

Study groups in NCT04992260
Study groupRoleWhat they receive
Experimental GroupExperimentalsubjects will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28.
Receives: Biological: Inactivated COVID-19 Vaccine
Control GroupPlacebo comparatorsubjects will receive two doses of placebo on day 0 and day 28.
Receives: Biological: Controlled vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 14 days after the second dose

Secondary outcomes (8)

  1. 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

    Measured: 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

    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

    Measured: 14 days after the second dose

  3. 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

    Measured: 14 days after the second dose

  4. 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

    Measured: During 7 days following each dose vaccination and during 28 days post-vaccination

  5. Safety index-occurrence and relationship of SAEs

    Occurrence and relationship of SAEs from first dose to 12 months after the last dose

    Measured: From first dose to 12 months after the last dose

  6. Safety index-occurrence and relationship of AESI

    Occurrence and relationship of AESI from first dose to 12 months after the last dose

    Measured: From first dose to 12 months after the last dose

  7. 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

    Measured: From first dose to 12 months after the last dose

  8. Immunogenicity index(subgroup)-Anti-SARS-CoV-2 S

    Analysis of Anti-SARS-CoV-2 S by electrochemiluminescence immunoassay to compare with the placebo group

    Measured: From first dose to 12 months after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start10 Sep 2021
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
11,349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04992260
Sponsor's protocol ID
PRO-nCOV-3002
Status last verified
Oct 2023
First submitted
3 Aug 2021
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xin Q, Wang K, Toh TH, Yuan Y, Meng X, Jiang Z, Zhang H, Yang J, Yang H, Zeng G. Efficacy, immunogenicity and safety of CoronaVac(R) in children and adolescents aged 6 months to 17 years: a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. Nat Commun. 2024 Aug 6;15(1):6660. doi: 10.1038/s41467-024-50802-2.

    PubMed 39107270

  • 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.

    PubMed 38812507

  • 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.

    PubMed 36383021

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inactivated COVID-19 Vaccine in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 38 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in Chile, South Africa, Malaysia, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy index-incidence of RT-PCR confirmed symptomatic COVID-19 cases with onset (time frame: 14 days after the second dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04992260, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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