The Phase IVd of Inactivated Enterovirus 71 Vaccine

Summary

Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.

Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old) in Guangdong Province, China.

Conditions

• Hand, Foot and Mouth Disease (HFMD)

Interventions

BIOLOGICAL

EV71 and two measles attenuated live vaccine

infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.

BIOLOGICAL

EV71 and attenuated Japanese encephalitis vaccine

infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.

BIOLOGICAL

two measles attenuated live vaccine

infants vaccined with one dose two measles attenuated live vaccine at 8 months old.

BIOLOGICAL

live attenuated Japanese encephalitis vaccine

infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.

BIOLOGICAL

EV71 vaccine

infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).

Sponsors & Collaborators

• Guangdong Center for Disease Prevention and Control

  collaborator OTHER_GOV

• Chinese Academy of Medical Sciences

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Months

Max Age

9 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-14

Primary Completion

2019-09-02

Completion

2019-09-02

Countries

• China

Study Locations