A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine

An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02001233

Enrollment

10077

Registered

2013-12-04

Start date

2013-03-31

Completion date

2014-10-31

Last updated

2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand, Foot and Mouth Disease

Keywords

EV71 vaccine, EV71-associated HFMD, efficacy, safety, immune persistence

Brief summary

The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Detailed description

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence. This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.

Interventions

BIOLOGICALEV71 vaccine

inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 35 Months

Healthy volunteers

Yes

Inclusion criteria

* All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.

Exclusion criteria

* subjects who refuse to continue in the study.

Design outcomes

Primary

Measure	Time frame	Description
The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination	Within the second year after the second vaccination	to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71

Secondary

Measure	Time frame	Description
The GMT of anti-EV71 antibodies in serum two years after second vaccination	26 months after second vaccination	to evaluate the immune persistence of anti-EV71 antibodies in serum
Frequency of serious adverse events (SAEs) with the second year after the second vaccination	within the second year after the second vaccination	Frequency of serious adverse events in healthy infants during the oney-year follow-up period

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026