Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine

NCT03281174 | Completed

• 1 other identifier: PRO-EV71-4007
• Study Type: observational
• Target: 343
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand, Foot and Mouth Disease

Keywords

Inactivated Enterovirus Type 71 (EV71) Vaccine; 5-year Immune Persistence

Outcome Measures

Primary Outcomes (1)

• The seropositive rate of EV71 neutralizing antibody-1

  Calculated based on the cutoff value of 1:8

  5 years (64 months)

Secondary Outcomes (3)

• The seropositive rate of EV71 neutralizing antibody-2

  5 years (64 months)

• The seropositive rate of EV71 neutralizing antibody-3

  5 years (64 months)

• The GMT of EV71 neutralizing antibody

  5 years (64 months)

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Received extra EV71 vaccination after the phase III clinical trial
• Refused to join the study

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Sheyang Center for Disease Control and Prevention

Yancheng, Jiangsu, 210009, China

Location

Related Publications (1)

• Hu Y, Zeng G, Chu K, Zhang J, Han W, Zhang Y, Li J, Zhu F. Five-year immunity persistence following immunization with inactivated enterovirus 71 type (EV71) vaccine in healthy children: A further observation. Hum Vaccin Immunother. 2018 Jun 3;14(6):1517-1523. doi: 10.1080/21645515.2018.1442997. Epub 2018 Apr 11.

  PMID: 29482422 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The venous blood was collected for EV71 neutralizing antibody detection

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Yuemei Hu

  Jiangsu Provicial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 13, 2017
• Study Start: May 20, 2017
• Primary Completion: May 21, 2017
• Study Completion: May 21, 2017
• Last Updated: September 13, 2017

Record last verified: 2017-09

Locations

CN (1)