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A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

NCT01508247 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10245

Last updated 2013-03-29

No results posted yet for this study

Summary

Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases. There has been a significant increase in EV71 epidemic activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen associated with a severe from of brainstem encephalitis associated with pulmonary oedema and high case-fatality rates.

The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. According to the immunogenicity and safety results, the 320U with adjuvant with immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.

Conditions

  • Hand, Foot and Mouth Disease
  • Herpangina
  • Other EV71-associated Diseases

Interventions

BIOLOGICAL

inactivated vaccine (Vero Cell) against EV71

inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28

BIOLOGICAL

0/0.5ml placebo

0/0.5ml placebo, two doses, on day0, 28

Sponsors & Collaborators

  • Bejing Vigoo Biological Co., LTD

    collaborator INDUSTRY

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Feng-Cai Zhu, Master · Jiangsu Provincial Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-03-31
Completion
2013-03-31

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 NCT01508247 on ClinicalTrials.gov