NCT03893747

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

Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

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.

Conditions

• Hand, Foot and Mouth Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2019-03-28
• Last updated: 2021-05-24

Locations

1 site across 1 country: China