Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial

NCT01636245 Phase 3 COMPLETED

The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.

Details

Lead sponsor	Sinovac Biotech Co., Ltd
Phase	Phase 3
Status	COMPLETED
Enrolment	1400
Start date	2012-07
Completion	2013-02

Conditions

• Hand, Foot and Mouth Disease

Interventions

• three consecutive lots of EV71 vaccine
• placebo

Primary outcomes

• The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen — 28 days after first vaccination
  to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination

Countries

China