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

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

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

Sponsors & Collaborators

• Wuhan Institute of Biological Products Co., Ltd

  collaborator INDUSTRY

• Jiangsu Province Centers for Disease Control and Prevention

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

35 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2020-05-01

Completion

2020-05-01

Countries

• China

Study Locations