Safety and Immunogenicity Study of an Inactivated Vaccine Against Hand, Foot and Mouth Disease Caused by Enterovirus 71

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

November 30, 2011

Study Completion Date

April 30, 2012

Conditions
Hand, Foot and Mouth Disease
Interventions
BIOLOGICAL

INV21 Low Dose

Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.

BIOLOGICAL

INV21 High Dose

Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.

BIOLOGICAL

Placebo

Phosphate Buffered Saline (PBS)

Trial Locations (1)

119074

Investigational Medicine Unit, National University Hospital, Singapore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Inviragen Inc.

INDUSTRY