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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05637229
Other study ID # PRO-EV71-4101
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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