NCT05112913

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

A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac）Between Different Workshops for Prevention of COVID-19 in Healthy Children Aged 3-17 Years

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,520 (estimated)
• Sponsor: Sinovac Research and Development Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a double-blind, randomized phase Ⅳ clinical trial in healthy children aged 3-17 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy children aged 3-17 years .The experimental vaccine was manufactured by Sinovac Research \& Development Co.,Ltd. A total of 2520 healthy subjects aged 3 to 17 years old will be enrolled.The subjects will be randomly divided into 7 groups of 360 participants per group with an equal probability to received 7 batches of commercial-scale vaccine.All subjects received two doses of vaccine on day 0 and day 28.

Conditions

• COVID-19

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-07-27
• Primary completion: 2021-11-19
• Completion: 2023-12-25
• First posted: 2021-11-09
• Last updated: 2023-11-07

Locations

1 site across 1 country: China