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A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants

NCT01399853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2012-05-31

No results posted yet for this study

Summary

Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.

The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase I study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. In order to provide more evidence for the immunogenicity of the vaccine, to further explore the probable immunizing dose and the safety profile of this vaccine, a phase II clinical trial is planed to conduct.

Conditions

  • Immunogenicity
  • Safety

Interventions

BIOLOGICAL

160U /0.5ml EV71 Vaccine

inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval

BIOLOGICAL

320U /0.5ml EV71 vaccine

inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval

BIOLOGICAL

640U /0.5ml EV71 vaccine

inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval

BIOLOGICAL

(without adjuvant) 640U /0.5ml

inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval

BIOLOGICAL

0/0.5ml placebo

0/0.5ml placebo, two doses, 28 days interval

Sponsors & Collaborators

  • Bejing Vigoo Biological Co., LTD

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-11-30
Completion
2012-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01399853 on ClinicalTrials.gov