A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

February 29, 2012

Conditions
The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and Infants
Interventions
BIOLOGICAL

160Eu/0.5ml in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

320Eu/0.5ml in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

640Eu/0.5ml in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in infants (6-11 months old)

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

0Eu/0.5ml in infants (6-11 months old)

0Eu/0.5ml placebo in 80 infants aged 6-11 months old on day 0, 28

BIOLOGICAL

160Eu/0.5ml in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

320Eu/0.5ml in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

640Eu/0.5ml in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in infants (12-23 months old)

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

0Eu/0.5ml in infants (12-23 months old)

0Eu/0.5ml placebo in 50 infants aged 12-23 months old on day 0, 28

BIOLOGICAL

160Eu/0.5ml in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

320Eu/0.5ml in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

640Eu/0.5ml in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

1280Eu/0.5ml (without adjuvant) in children (24 months-5 years old)

inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28

BIOLOGICAL

0Eu/0.5ml in children (24 months-5 years old)

0Eu/0.5ml placebo in 50 children aged 24 months-5 years 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

NCT01512706 - A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants | Biotech Hunter | Biotech Hunter