A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
- Conditions
- Hand, Foot and Mouth Disease
- Registration Number
- NCT05637229
- Lead Sponsor
- Sinovac Biotech Co., Ltd
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- 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.
- Children with difficulty to withdraw the blood during blood collection
- Children with severe illness who require further treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Seroprevalence of EV71 antibodies 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 Outcome Measures
Name Time Method Proportion of abnormality result for Routine blood tests 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 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)
Trial Locations
- Locations (2)
Padalarang Health Center
🇮🇩Bandung, Indonesia
Garuda Health Center
🇮🇩Bandung, Indonesia