A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-28

Study Completion Date

2022-12-19

Brief Summary

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This study is a sero-survey study of infants aged 6 months to 71 months in Bandung City and West Bandung District. As initial data to find out how many children have been exposed to human enterovirus type 71 (HEV-71) which causes Hand, foot, and mouth disease (HFMD).

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Detailed Description

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This study is a cross-sectional seroprevalence survey of EV-71, associated with HFMD, among children aged between 6 to 71 months in Bandung, sampled from urban and rural Primary Health Center in Bandung, Indonesia. This study was implemented by Department of Child Health Hasan Sadikin General Hospital/Medical Faculty Universitas Padjadjaran Bandung, West Java. Age-stratified sample of 600 children aged 6-71 months will be conducted from these sites. Samples testing includes routine blood counts, enzyme-linked immunosorbent assays (ELISAs) for enterovirus type 71 (EV71) IgG and ELISAs for other HFMD-associated enteroviruses.

Conditions

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Hand, Foot and Mouth Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Children aged 6 months to 71 months.
* The participant's parent/guardian receives an explanation and receives a Letter of Consent after the explanation (informed consent) and provided a documented informed consent by parents/legally accepted representative (LAR) participants prior to the study procedures.
* Domicile in Bandung and West Bandung District for at least 6 months.