Enterovirus 71 Vaccine
Conditions
Keywords
vaccine, safety
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.
Interventions
BIOLOGICALtwo doses enterovirus 71 vaccine
Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.
Sponsors
Beijing Chaoyang District Centre for Disease Control and Prevention
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed