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

Hand, Foot and Mouth Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05637229
• Other study ID #: PRO-EV71-4101
• Status: Completed
• Start date: November 28, 2022
• Est. completion date: December 19, 2022

Study information

• Verified date: October 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 19, 2022
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 71 Months

Eligibility

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

Related Conditions & MeSH terms

• Hand, Foot and Mouth Disease
• Mouth Diseases

Locations

Country	Name	City	State
Indonesia	Garuda Health Center	Bandung
Indonesia	Padalarang Health Center	Bandung

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprevalence of EV71 antibodies	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)	Immediately after sampling
Secondary	Proportion of abnormality result for Routine blood tests	Proportion of abnormality result for Routine blood tests (Red blood cells, white blood cells, platelets, haemoglobin, haematocrit).	Immediately after sampling
Secondary	seroprevalence of other HFMD-associated enteroviruses antibodies	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)	Immediately after sampling