Back to resultsSafety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
Primary Purpose
Enterovirus 71 Vaccine
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
two doses enterovirus 71 vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Enterovirus 71 Vaccine focused on measuring vaccine, safety
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
two doses enterovirus 71 vaccine
Arm Description
Two doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02806531
First Posted
June 16, 2016
Last Updated
June 17, 2016
Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02806531
Brief Title
Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterovirus 71 Vaccine
Keywords
vaccine, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
two doses enterovirus 71 vaccine
Arm Type
Experimental
Arm Description
Two doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval.
Intervention Type
Biological
Intervention Name(s)
two doses enterovirus 71 vaccine
Intervention Description
Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.
Primary Outcome Measure Information:
Title
The rate of adverse reactions of enterovirus 71 Vaccine
Description
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
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
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