Clinical trial NCT03893747: Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Official title: Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Conditions: Hand, Foot and Mouth Disease
Summary: This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.
Interventions:
description: 500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
name: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
type: Biological
description: 500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
name: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
type: Biological
description: 500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
name: The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
type: Biological
description: 500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
name: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
type: Biological
description: 500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
name: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
type: Biological
description: 500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
name: The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
type: Biological
Study arms:
design_group_description: 500 subjects will be randomly received the first batch vaccine producted by 40 L reactor
design_group_title: the first batch vaccine producted by 40 L reactor
design_group_type: Experimental
design_group_description: 500 subjects will be randomly received the second batch vaccine producted by 40 L reactor
design_group_title: the second batch vaccine producted by 40 L reactor
design_group_type: Experimental
design_group_description: 500 subjects will be randomly received the third batch vaccine producted by 40 L reactor
design_group_title: the third batch vaccine producted by 40 L reactor
design_group_type: Experimental
design_group_description: 500 subjects will be randomly received the first batch vaccine producted by 150 L reactor
design_group_title: the first batch vaccine producted by 150 L reactor
design_group_type: Experimental
design_group_description: 500 subjects will be randomly received the second batch vaccine producted by 150 L reactor
design_group_title: the second batch vaccine producted by 150 L reactor
design_group_type: Experimental
design_group_description: 500 subjects will be randomly received the third batch vaccine producted by 150 L reactor
design_group_title: the third batch vaccine proudected by 150 L reactor
design_group_type: Experimental
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Collaborators: Wuhan Institute of Biological Products Co., Ltd.
Drug name mappings:
name: 肠道病毒71型灭活疫苗 (武汉生物制品研究所)
lang: CN
name: Enterovirus 71 vaccine(Wuhan Institute of Biological Products)
lang: EN