Hand, Foot and Mouth Disease
Conditions
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.
Interventions
None listed
Sponsors
Sinovac Biotech Co., Ltd
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
6 Months to 71 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Indonesia
Outcome results
None listed