ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 32 for:    "Hand, Foot and Mouth Disease"

Five-year Immune Persistence Study of 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: NCT03281174
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Brief 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.

Condition or disease
Hand, Foot and Mouth Disease

Detailed 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.


Study Type : Observational
Actual Enrollment : 343 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine
Actual Study Start Date : May 20, 2017
Actual Primary Completion Date : May 21, 2017
Actual Study Completion Date : May 21, 2017

Group/Cohort
EV71 vaccine group
The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial.
Placebo group
The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial.



Primary Outcome Measures :
  1. The seropositive rate of EV71 neutralizing antibody-1 [ Time Frame: 5 years (64 months) ]
    Calculated based on the cutoff value of 1:8


Secondary Outcome Measures :
  1. The seropositive rate of EV71 neutralizing antibody-2 [ Time Frame: 5 years (64 months) ]
    Calculated based on the cutoff value of 1:16

  2. The seropositive rate of EV71 neutralizing antibody-3 [ Time Frame: 5 years (64 months) ]
    Calculated based on the cutoff value of 1:32

  3. The GMT of EV71 neutralizing antibody [ Time Frame: 5 years (64 months) ]
    The GMT of EV71 neutralizing antibody 64 months after the first dose injection


Biospecimen Retention:   Samples Without DNA
The venous blood was collected for EV71 neutralizing antibody detection


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:   Non-Probability Sample
Study Population
The studied subjects are infants aged 6-35 months old infants when enrolled into the phase III clinical trial, and they are children aged 6-8 years old five years after the EV71 vaccine /placebo injection.
Criteria

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

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): NCT03281174


Locations
China, Jiangsu
Sheyang Center for Disease Control and Prevention
Yancheng, Jiangsu, China, 210009
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Yuemei Hu Jiangsu Provicial Center for Disease Control and Prevention

Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03281174     History of Changes
Other Study ID Numbers: PRO-EV71-4007
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sinovac Biotech Co., Ltd:
Inactivated Enterovirus Type 71 (EV71) Vaccine
5-year Immune Persistence

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