NCT05003466

Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years(COVID-19)

A Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Shenzhen Kangtai Biological Products Co., LTD · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Vaccine (Vero Cells), Inactivated	2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated with a 28-day interval constitute a primary immunization course. The third dose on 6 months after primary course is the booster dose. Administer as an intramuscular injection into the lateral deltoid of the upper arm.
BIOLOGICAL	Placebo	2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-03-01
• Completion: 2023-04-01
• First posted: 2021-08-12
• Last updated: 2021-08-18

Locations

1 site across 1 country: China