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Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children

NCT01273246 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-07-28

No results posted yet for this study

Summary

A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).

Conditions

  • Hand-foot-mouth Disease
  • Infection; Viral, Enterovirus

Interventions

BIOLOGICAL

100U inactivated Enterovirus Type 71 Vaccine

Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm

BIOLOGICAL

200U inactivated Enterovirus Type 71 Vaccine

Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm

BIOLOGICAL

400U inactivated Enterovirus Type 71 Vaccine

Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm

BIOLOGICAL

Placebo

Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm

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
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-06-30
Completion
2011-07-31

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 NCT01273246 on ClinicalTrials.gov