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Status unknownNCT02806531Updated Jun 20, 2016

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

A Phase 4 interventional study of two doses enterovirus 71 vaccine in Enterovirus 71 Vaccine, sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention. Status unknown. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-20.

Sponsored by Beijing Chaoyang District Centre for Disease Control and Prevention · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20,000
Allocation
Not applicable
Ages
6 Months to 35 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Enterovirus 71 Vaccine

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Keywords

  • vaccine
  • safety
03

In context

Enterovirus Infections

47 studies on the registry are indexed under Enterovirus Infections; 5 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 150 across 31 interventional studies indexed under Enterovirus Infections.

Browse Enterovirus Infections studies →

Lead sponsor

Beijing Chaoyang District Centre for Disease Control and Prevention is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 35 Months
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20,000 participants (estimated)

Study arms

  • Experimental
    two doses enterovirus 71 vaccine

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

    Biological: two doses enterovirus 71 vaccine

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02806531
Lead sponsor
Beijing Chaoyang District Centre for Disease Control and Prevention
Responsible party
Sponsor
First posted
Jun 20, 2016
Start date
Jul 2016
Primary completion
Jul 2018 (estimated)
Last update
Jun 20, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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