Enterovirus 71 Vaccine Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 20000 |
| Est. completion date | |
| Est. primary completion date | July 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Months to 35 Months |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Chaoyang District Centre for Disease Control and Prevention |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |