Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China

PHASE4CompletedINTERVENTIONAL
Enrollment

3,000

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

May 1, 2020

Study Completion Date

May 1, 2020

Conditions
Hand, Foot and Mouth Disease
Interventions
BIOLOGICAL

The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

BIOLOGICAL

The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

BIOLOGICAL

The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

BIOLOGICAL

The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

BIOLOGICAL

The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

BIOLOGICAL

The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor

500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor

Trial Locations (1)

Unknown

Fengcai Zhu, Nanjing

All Listed Sponsors
collaborator

Wuhan Institute of Biological Products Co., Ltd

INDUSTRY

lead

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

NCT03893747 - Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China | Biotech Hunter | Biotech Hunter