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NCT02001233 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
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Completed NCT04133584 - The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine Phase 4
Completed NCT03241030 - Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial Phase 2
Completed NCT01255124 - Study on Dynamic Changes of the Maternal Anti-EV71 and Anti-CVA16 Antibody Levels in Infants and Young Children N/A
Completed NCT03873740 - Immunogenicity and Safety of Two Different Commercial EV71 Vaccines Phase 4
Completed NCT05637229 - A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
Recruiting NCT06146088 - Lot-to-lot Consistency Study of Three Commercial Batches of Enterovirus 71 Vaccine Phase 4
Active, not recruiting NCT06209398 - Immunogenicity of the Inactivated EV71 Vaccine Combined With Hepatitis B and Group A Meningococcal Vaccine Phase 4
Recruiting NCT01175915 - A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Recruiting NCT01145664 - A Multi-Center Clinical Trial To Evaluate Chinese Herbal Medicines in the Treatment of Severe Hand-foot-mouth Disease N/A
Completed NCT01182532 - A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Completed NCT03281174 - Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine N/A
Completed NCT03582761 - Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71 Phase 4
Completed NCT03903926 - Efficacy Trial of a Commercial EV71 Vaccine Phase 4
Completed NCT03909074 - Clinical Trial of Enterovirus 71（EV71） Inactivated Vaccine in Children Aged 36-71 Months Phase 3
Completed NCT01769794 - Chinese Medicinal Treatment on Mild Hand, Foot, and Mouth Disease: Multicenter, Prospective, Randomized Double-blind, Placebo-controlled Study N/A
Recruiting NCT01182025 - A Clinical Trial to Evaluate the Effectiveness and Safety of Xiyanping Injection in the Treatment of Mild Type of Hand, Foot, and Mouth Disease N/A
Recruiting NCT06263439 - Surveillance of HFMD in Pediatric Outpatients
Not yet recruiting NCT05397587 - An Immunity Persistence Study of Enterovirus 71 Inactivated Vaccine (Vero Cell) Phase 4
Completed NCT04111432 - Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With Expanded Programme on Immunization Vaccines Phase 4