ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 38 for:    ev71

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02001233
Recruitment Status : Completed
First Posted : December 4, 2013
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

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.

Condition or disease Intervention/treatment
Hand, Foot and Mouth Disease Biological: EV71 vaccine

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.


Study Type : Observational
Actual Enrollment : 10077 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
EV71 Vaccine
Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
Biological: EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
Placebo
placebo in 5000 infants aged 6-35 months old on day0,28



Primary Outcome Measures :
  1. The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination [ Time Frame: Within the second year after the second vaccination ]
    to evaluate the efficacy of EV71 vacccine against HFMD caused by EV71


Secondary Outcome Measures :
  1. The GMT of anti-EV71 antibodies in serum two years after second vaccination [ Time Frame: 26 months after second vaccination ]
    to evaluate the immune persistence of anti-EV71 antibodies in serum

  2. Frequency of serious adverse events (SAEs) with the second year after the second vaccination [ Time Frame: within the second year after the second vaccination ]
    Frequency of serious adverse events in healthy infants during the oney-year follow-up period


Biospecimen Retention:   Samples With DNA

Serum samples will be taken from 1200 subjects in the immunogenicity subgroup 26 months after the first vaccination.

Throat and anal swab samples will be taken from the cases with Hand, Foot and mouth disease for the detection of PCR assays and the isolation of EV71.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Chinese infants aged 6 to 35 months old
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001233


Locations
China, Jiangsu
Ganyu
Lianyungang, Jiangsu, China, 222100
Taixing
Taizhou, Jiangsu, China, 225400
Sheyang
Yancheng, Jiangsu, China, 224300
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Feng-Cai Zhu, BS Jiangsu Center for Diseases Control and Prevention

Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT02001233     History of Changes
Other Study ID Numbers: PRO-EV71-3003
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Keywords provided by Sinovac Biotech Co., Ltd:
EV71 vaccine
EV71-associated HFMD
efficacy
safety
immune persistence

Additional relevant MeSH terms:
Mouth Diseases
Enterovirus Infections
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs