CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11,349 enrolled
Drug / intervention
Inactivated COVID-19 Vaccine +1 morebiological
Likely dose
Inactivated COVID-19 Vaccine 5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04992260
NCT04992260Phase 3Completed
CompareCT.gov

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

Sinovac Research and Development Co., Ltd.·interventional·Posted Aug 5, 2021·Updated Oct 16, 2023

In Brief

A Phase 3 clinical trial evaluating Inactivated COVID-19 Vaccine and Controlled vaccine for COVID-19. Completed, enrolled 11,349 participants across 38 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesChile, Malaysia, Philippines, South Africa
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedAug 5, 2021
Enrollment StartSep 10, 2021
Primary CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.9 years ago

Interventions

Inactivated COVID-19 Vaccinebiological

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

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.