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Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

NCT01421121 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2012-11-27

No results posted yet for this study

Summary

A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.

Conditions

  • Infection, Viral, Enterovirus

Interventions

BIOLOGICAL

100U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval

BIOLOGICAL

200 U EV71 vaccine with adjuvant

inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval

BIOLOGICAL

400U EV71 vaccine with adjuvant

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

BIOLOGICAL

200U EV71 vaccine without adjuvant

inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval

BIOLOGICAL

Placebo

0.5ml placebo, two doses, 28 days interval

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yan-pin Li, MD · Guangxi Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT01421121 on ClinicalTrials.gov