A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
1 other identifier
observational
600
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2022
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2022
CompletedStudy Start
First participant enrolled
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2022
CompletedOctober 31, 2023
October 1, 2023
21 days
November 8, 2022
October 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Proportion of abnormality result for Routine blood tests
Immediately after sampling
seroprevalence of other HFMD-associated enteroviruses antibodies
Immediately after sampling
Eligibility Criteria
The study population are children aged between 6 to 71 months in Bandung, sampled from urban and rural Primary Health Center in Bandung, Indonesia
You may qualify if:
- 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.
You may not qualify if:
- Children with difficulty to withdraw the blood during blood collection
- Children with severe illness who require further treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Garuda Health Center
Bandung, Indonesia
Padalarang Health Center
Bandung, Indonesia
Related Publications (1)
Girsang RT, Rusmil K, Fadlyana E, Setiabudiawan B, Adrizain R, Mulyadi RP, Budiman A, Utami RK, Mardiah BZ, Dwi Putra MG, Fulendry FP, Nashsyah DT, Sukandar H. A serosurvey study of hand, foot and mouth disease in healthy children aged 6 to 71 months old in West Bandung and Bandung Region, Indonesia. BMC Infect Dis. 2025 Jan 27;25(1):124. doi: 10.1186/s12879-025-10453-0.
PMID: 39871167DERIVED
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodman Tarigan, Doctor
Hasan Sadikin Hospital/School of Medicine, Padjadjaran University, Bandung
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2022
First Posted
December 5, 2022
Study Start
November 28, 2022
Primary Completion
December 19, 2022
Study Completion
December 19, 2022
Last Updated
October 31, 2023
Record last verified: 2023-10