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NCT04884685

Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Children and Adolescents

Completed Phase 2 Last updated 22 September 2023
What this trial tests

Phase 2 trial testing SARS-CoV-2 Inactivated Vaccine in COVID-19 in 500 participants. Completed in 20 June 2022.

Timeline
3 May 2021
Primary endpoint
1 August 2021
20 June 2022

Quick facts

Lead sponsorSinovac Life Sciences Co., Ltd.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment500
Start date3 May 2021
Primary completion1 August 2021
Estimated completion20 June 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sinovac Life Sciences Co., Ltd. — full company profile →

Who can join

Adults 3 to 17, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized, double-blinded, placebo-controlled, phase Ⅱb clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in healthy children and adolescents aged 3-17 years.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of COVID-19 vaccines.
    Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
  2. COVID-19 Vaccination in Pregnancy, Paediatrics, Immunocompromised Patients, and Persons with History of Allergy or Prior SARS-CoV-2 Infection: Overview of Current Recommendations and Pre- and Post-Marketing Evidence for Vaccine Efficacy and Safety.
    Luxi N, Giovanazzi A, Capuano A, Crisafulli S, et al · · 2021 · cited 98× · PMID 34739716 · DOI 10.1007/s40264-021-01131-6
  3. Safety and efficacy of COVID-19 vaccines in children and adolescents: A systematic review of randomized controlled trials.
    Tian F, Yang R, Chen Z. · · 2022 · cited 47× · PMID 35705969 · DOI 10.1002/jmv.27940
  4. COVID-19: Clinical status of vaccine development to date.
    Kumar S, Basu M, Ghosh P, Ansari A, et al · · 2023 · cited 17× · PMID 36184710 · DOI 10.1111/bcp.15552
  5. Multi-omics for COVID-19: driving development of therapeutics and vaccines.
    Guo M, Xiong M, Peng J, Guan T, et al · · 2023 · cited 14× · PMID 37936830 · DOI 10.1093/nsr/nwad161
  6. COVID-19 vaccination in pediatric cancer patients: A high priority.
    Charla Y, Kalra M, Chopra N, Choudhury S. · · 2021 · cited 8× · PMID 34636133 · DOI 10.1002/pbc.29397

Verify or expand the search:

Other trials of SARS-CoV-2 Inactivated Vaccine

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Other Sinovac Life Sciences Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04884685.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing