NCT01569581View on ClinicalTrials.gov

A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children

PHASE3CompletedINTERVENTIONAL
Enrollment

12,000

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
The Efficacy of Inactivated EV71 Vaccine (KMB17) Against HFMD in Chinese Children and Infants
Interventions
BIOLOGICAL

100U/0.5ml in 6-11 months old infants

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

100U/0.5ml in 12-23 months old infants

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

100U/0.5ml in 24-35 months old children

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1500 children aged 24-35 months old on day 0, 28

BIOLOGICAL

100U/0.5ml in 36-71 months old children

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1000 children aged 36-71 months old on day 0, 28

Trial Locations (1)

Unknown

Guangxi Provincial Center for Diseases Control and Prevention, Nanning

All Listed Sponsors
collaborator

Guangxi Center for Disease Control and Prevention

OTHER_GOV

lead

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

NCT01569581 - A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children | Biotech Hunter | Biotech Hunter