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Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in Infants

NCT01812135 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-07-29

No results posted yet for this study

Summary

A randomized, double-blind, phase II-02 clinical trial is to evaluate the safety and immunogenicity of an inactivated EV71 vaccine with or without aluminum adjuvant

Conditions

  • Infection, Viral, Enterovirus

Interventions

BIOLOGICAL

400 U EV71 vaccine with adjuvant

400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant

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 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-11-30
Completion
2011-12-31

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 NCT01812135 on ClinicalTrials.gov