drugset / Trial / NCT05112913

Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years

NCT05112913 ↗

Phase 4 Unknown 2520 enrolled Sinovac Research and Development Co., Ltd.
RandomizedParallel-groupDouble-blindPrevention

Summary

This study is a double-blind, randomized phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine (CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the lot-to-lot consistency ,immunogenicity and safety of COVID-19 vaccine between the commercialized scale in workshop 2 and 3 and the commercialized scale in workshop 1 in healthy children aged 3-17 years.

Timeline

Start
2021-07-27
Primary completion
2021-11-19
Completion
2023-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Inactivated SARS-CoV-2 vaccine (Vero cell) Vaccine 0.5 ml —
Subject Inactivated SARS-CoV-2 vaccine (Vero cell) Vaccine 600 unknown —

Indications