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

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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Key information

Conditions

Hand, Foot and Mouth Disease Coxsackievirus Infections Enterovirus Infections Infections Picornaviridae Infections RNA Virus Infections Virus Diseases

Age range

6 month–71 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Garuda Health Center, Bandung, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

Children with difficulty to withdraw the blood during blood collection
Children with severe illness who require further treatment

Treatment and study plan

Primary outcomes

Seroprevalence of EV71 antibodies

Time frame: Immediately after sampling

Proportion of participants who are seropositive (IgG) for EV-71 and proportion of participants who are seropositive for EV-71 per predefined age-groups (6 - 35 months and 36 - 71 months)

Secondary outcomes

Proportion of abnormality result for Routine blood tests

Time frame: Immediately after sampling

Proportion of abnormality result for Routine blood tests (Red blood cells, white blood cells, platelets, haemoglobin, haematocrit).
seroprevalence of other HFMD-associated enteroviruses antibodies

Time frame: Immediately after sampling

Proportion of participants who are seropositive (IgG) for and other HFMD-associated enteroviruses and proportion of participants who are seropositive for and other HFMD-associated enteroviruses per predefined age-groups (6 - 35 months and 36 - 71 months)

Sponsors and collaborators

Lead sponsor

Sinovac Biotech Co., Ltd

Industry

Registry information

Official study title

A Serosurvey Study of Hand, Foot, and Mouth Disease in Healthy Children Aged 6 to 71 Months Old in Bandung and West Bandung District, Indonesia

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Dec 5, 2022
Registry last updated: Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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