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

Hand, Foot and Mouth Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001233
• Other study ID #: PRO-EV71-3003-0
• Status: Completed
• Start date: March 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10077
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Intervention

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

Locations

Country	Name	City	State
China	Ganyu	Lianyungang	Jiangsu
China	Taixing	Taizhou	Jiangsu
China	Sheyang	Yancheng	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination	to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71	Within the second year after the second vaccination
Secondary	The GMT of anti-EV71 antibodies in serum two years after second vaccination	to evaluate the immune persistence of anti-EV71 antibodies in serum	26 months after second vaccination
Secondary	Frequency of serious adverse events (SAEs) with the second year after the second vaccination	Frequency of serious adverse events in healthy infants during the oney-year follow-up period	within the second year after the second vaccination