Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2011

Study Completion Date

December 31, 2011

Conditions
Infection, Viral, Enterovirus
Interventions
BIOLOGICAL

100U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval

BIOLOGICAL

200 U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval

BIOLOGICAL

400U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

BIOLOGICAL

200U EV71 vaccine without adjuvant

inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval

BIOLOGICAL

Placebo

0.5ml placebo, two doses, 28 days interval

Trial Locations (1)

Unknown

GuangXi Center for Diseases Control and Prevention, Nanning

All Listed Sponsors
lead

Sinovac Biotech Co., Ltd

INDUSTRY

NCT01421121 - Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants | Biotech Hunter | Biotech Hunter