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Phase IV Clinical Trial, Immunogenicity and Safety of EV71 Vaccine

NCT03278132 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-01-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety of EV71 vaccine in infants aged 6 to 35 months old, by detecting the dynamic changes of neutralizing antibody at different time after vaccination

Conditions

  • Hand, Foot and Mouth Disease

Interventions

BIOLOGICAL

EV71 vaccine

Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.

Sponsors & Collaborators

  • Zhejiang Provincial Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Shangyu District Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Huakun Lv · Zhejiang Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-16
Primary Completion
2017-09-15
Completion
2017-09-15

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 NCT03278132 on ClinicalTrials.gov