NCT02806531

Brief Summary

This phase IV clinical study evaluates the safety of enterovirus 71 vaccine in children aged 6-35 months old by the method of both passive and active surveillance.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

June 16, 2016

Last Update Submit

June 17, 2016

Conditions

Enterovirus 71 Vaccine

Keywords

vaccinesafety

Outcome Measures

Primary Outcomes (1)

  • The rate of adverse reactions of enterovirus 71 Vaccine

    Adverse reactions associated with vaccine will be observed in subjects after each vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy

    28 days

Study Arms (1)

two doses enterovirus 71 vaccine

EXPERIMENTAL

Two doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval.

Biological: two doses enterovirus 71 vaccine

Interventions

two doses enterovirus 71 vaccineBIOLOGICAL

Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.

two doses enterovirus 71 vaccine

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infant and toddlers aged 6 and 35 months, meeting the criteria of receiving vaccine based on the judgement of caregivers at vaccination clinic. And The legal guardian are willing to vaccination at his own expense.

You may not qualify if:

  • History of allergy to any vaccine ingredient or gentamycin;
  • Fever, or acute disease, or acute stage of chronic disease;
  • Having serious chronic diseases, or allergic constitution;
  • Refusal of follow-up for safety concern.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 20, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Last Updated

June 20, 2016

Record last verified: 2016-06