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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2014

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.

Interventions

  • Biological: EV71 vaccine
    • inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval

Arms, Groups and Cohorts

  • EV71 Vaccine
    • Inactivated vaccine (vero cell) against EV71 of 400U /0.5ml in 5000 infants aged 6-35 months old on day0,28
  • Placebo
    • placebo in 5000 infants aged 6-35 months old on day0,28

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 35 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sinovac Biotech Co., Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Feng-Cai Zhu, BS, Principal Investigator, Jiangsu Center for Diseases Control and Prevention

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