NCT01812135

Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants

A Double-blind and Randomized, Phase II -02 Study With Inactivated EV71 Vaccines in Healthy Infants

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 11 Months
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant

Conditions

• Infection, Viral, Enterovirus

Interventions

Type	Name	Description
BIOLOGICAL	400 U EV71 vaccine with adjuvant	400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2013-03-15
• Last updated: 2021-07-29

Locations

1 site across 1 country: China