Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03281174
Other study ID # PRO-EV71-4007
Secondary ID
Status Completed
Phase N/A
First received September 8, 2017
Last updated September 8, 2017
Start date May 20, 2017
Est. completion date May 21, 2017

Study information

Verified date September 2017
Source Sinovac Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.


Description:

The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China,and a follow up study for phase III clinical trial has completed on March 2014.

On the basis of phase III, this study is the Phase IV, open-labelled research, in order to evaluate the 5-year immune persistence of EV71 vaccine.


Recruitment information / eligibility

Status Completed
Enrollment 343
Est. completion date May 21, 2017
Est. primary completion date May 21, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 35 Months
Eligibility Inclusion Criteria:

In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with 435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).

The subjects in Sheyang immunogenicity subgroup with the following conditions were included in this study:

- Guardian(s) of the volunteer should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study

- Received at least one injection of EV71 vaccine or the placebo in the phase III clinical trial

- Finished the blood sampling 64 months after the vaccination

Exclusion Criteria:

- Received extra EV71 vaccination after the phase III clinical trial

- Refused to join the study

Study Design


Locations

Country Name City State
China Sheyang Center for Disease Control and Prevention 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 seropositive rate of EV71 neutralizing antibody-1 Calculated based on the cutoff value of 1:8 5 years (64 months)
Secondary The seropositive rate of EV71 neutralizing antibody-2 Calculated based on the cutoff value of 1:16 5 years (64 months)
Secondary The seropositive rate of EV71 neutralizing antibody-3 Calculated based on the cutoff value of 1:32 5 years (64 months)
Secondary The GMT of EV71 neutralizing antibody The GMT of EV71 neutralizing antibody 64 months after the first dose injection 5 years (64 months)
See also
  Status Clinical Trial Phase
Recruiting NCT06063057 - Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial Phase 1/Phase 2
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 NCT03582761 - Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71 Phase 4
Completed NCT03903926 - Efficacy Trial of a Commercial EV71 Vaccine Phase 4
Completed NCT02001233 - A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
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