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

B

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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