Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old
Phase 4
- Conditions
- Enterovirus 71 Vaccine
- Interventions
- Biological: two doses enterovirus 71 vaccine
- Registration Number
- NCT02806531
- Lead Sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20000
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description two doses enterovirus 71 vaccine two doses enterovirus 71 vaccine Two doses of enterovirus 71 vaccine will be given in aged 6-35 months old, 28 days interval.
- Primary Outcome Measures
Name Time Method The rate of adverse reactions of enterovirus 71 Vaccine 28 days 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
Name Time Method