MedTrace Logo

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

NCT05112913 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2520

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

BIOLOGICAL

Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1

600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection

Sponsors & Collaborators

  • Sinovac Research and Development Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weijun Hu, Master · Shanxi Provincial Center for Disease Prevention and Control

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05112913 on ClinicalTrials.gov