Safety Study of Enterovirus 71 Vaccine in Children Aged 6-35 Months Old

Beijing Chaoyang District Centre for Disease Control and Prevention

Status and phase: Unknown; Phase 4

Conditions: Enterovirus 71 Vaccine

Treatments: Biological: two doses enterovirus 71 vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT02806531

cycdc2016-2

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 6 to 35 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20,000 participants in 1 patient group

two doses enterovirus 71 vaccine

Experimental group

Description:

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

Treatment:

Biological: two doses enterovirus 71 vaccine