NCT05637229

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

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.

Conditions

• Hand, Foot and Mouth Disease

Timeline

• Start date: 2022-11-28
• Primary completion: 2022-12-19
• Completion: 2022-12-19
• First posted: 2022-12-05
• Last updated: 2023-10-31

Locations

2 sites across 1 country: Indonesia