NCT05913024

Immunogenicity and Safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in Volunteers Aged From 6 to 71 Months

A Single-center, Randomized, Blinded, Different Doses, Positive Control, Phase II to Evaluate the Inactivated EV71 Vaccine Immunogenicity and Safety in Healthy Volunteers Aged 6 to 71 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 470 (actual)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.

Detailed description

The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months. Qualified subjects were screened and randomly divided into low-dose group, high-dose group, and control group according to the ratio of 2:2:1. The experimental group was vaccinated with the experimental vaccine (low-dose or high-dose enterovirus 71 inactivated vaccine from Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.), and the control group was vaccinated with the control vaccine (enterovirus 71 inactivated vaccine produced by the Institute of Medical Biology of the Chinese Academy of Medical Sciences). All participants received two doses of the vaccine 28 days apart.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Enterovirus Type 71 Vaccine	Participants received two doses of the vaccine, 28 days apart

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-10-24
• Completion: 2022-10-24
• First posted: 2023-06-22
• Last updated: 2023-07-05

Locations

1 site across 1 country: China