Hand, Foot and Mouth DiseaseNCT05637229
A Serosurvey Study of Hand, Foot, and Mouth Disease in Indonesia
An observational study of Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 2 sites in Indonesia.
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). Read more about this study
- Who is it for?
- Ages 6 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- How many people
- 600 participants
- Where
- 2 sitesIndonesia
- Study dates
- 28 Nov 2022to 19 Dec 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population are children aged between 6 to 71 months in Bandung, sampled from urban and rural Primary Health Center in Bandung, Indonesia
Who may be able to join
- 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.
Who cannot join
- Children with difficulty to withdraw the blood during blood collection
- Children with severe illness who require further treatment
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Garuda Health Center
Bandung
Padalarang Health Center
Bandung
About this study
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
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).
Read the 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
- Medical subject headings
- Hand, Foot and Mouth Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Immediately after sampling
Secondary outcomes (2)
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).
Measured: Immediately after sampling
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)
Measured: Immediately after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start28 Nov 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 600 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodman Tarigan, Doctor, Principal investigator, Hasan Sadikin Hospital/School of Medicine, Padjadjaran University, Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637229
- Sponsor's protocol ID
- PRO-EV71-4101
- Status last verified
- Oct 2023
- First submitted
- 8 Nov 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39871167
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05637229
- Acronym / sponsor ID
- PRO-EV71-4101
- Conditions
- Hand, Foot and Mouth Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 6 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population are children aged between 6 to 71 months in Bandung, sampled from urban and rural Primary Health Center in Bandung, Indonesia
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with difficulty to withdraw the blood during blood collection
- Children with severe illness who require further treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seroprevalence of EV71 antibodies
Time frame: 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)
2 secondary outcomes
Proportion of abnormality result for Routine blood tests
Time frame: Immediately after sampling
seroprevalence of other HFMD-associated enteroviruses antibodies
Time frame: Immediately after sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Derived from this study: PubMed 39871167Girsang 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.
Related trials for Hand, Foot and Mouth Disease
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Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
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Phase I Clinical Trial of Enterovirus Type71 - Coxsackievirus Type A16 Bivalent Vaccine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodman Tarigan, Doctor principal investigator
Hasan Sadikin Hospital/School of Medicine, Padjadjaran University, Bandung
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroprevalence of EV71 antibodies (time frame: Immediately after sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.