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Completed

NCT Number: NCT02001233

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

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.

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Key information

Conditions

Hand, Foot and Mouth Disease Coxsackievirus Infections Enterovirus Infections Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ganyu, Lianyungang, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EV71 vaccine

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2013
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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