An observational study in Hand, Foot and Mouth Disease, sponsored by Sinovac Biotech Co., Ltd. Not yet recruiting. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Sinovac Biotech Co., Ltd · Observational
Among 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd — 4 open to participants now, 4 under way, 2 of them phase 3. Hand, Foot and Mouth Disease · Sinovac Biotech Co., Ltd.
Among the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd, this one is one of 2 that started in 2024, is one of 5 observational ones, and was the 16th registered.
59 studies on the registry are indexed under Hand, Foot and Mouth Disease; 10 are open to participants now.
Browse Hand, Foot and Mouth Disease studies →4 of the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd are open now, in 2 countries. Recruiting first, the newest first:
Sinovac Biotech Co., Ltd · Sites in China
Sinovac Biotech Co., Ltd · Sites in Vietnam
Sinovac Biotech Co., Ltd · Sites in China
By country, each count listing its studies:
Of the 4 Hand, Foot and Mouth Disease studies recruiting now, 1 (25%) set no upper age limit and 3 (75%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 6 Months to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 2 · Phase 3 5 · Phase 4 6
First in 2011; this study’s year is marked. 2 started in 2024.
Median enrollment 744 across the 15 interventional studies, 600 across the 5 observational. Of the 14 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Sinovac Biotech Co., Ltd is the lead sponsor of 93 studies on the registry; 19 are open to participants now.
1 of the studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07793175Sinovac Biotech Co., LtdBridging Clinical Trial of EV71 Vaccine in Vietnamese Children | 2027-01-09 |
Among the 20 studies in Hand, Foot and Mouth Disease by Sinovac Biotech Co., Ltd, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
An observational study of active case surveillance to identify the pathogens of clinically diagnosed HFMD cases aged 6 months to 18 years old recruited from puskesmas and hospitals in Indonesia.
Every time suspected case of HFMD presented to the hospital, the pediatrician will inform the patient to enroll in the study. After the subject signs the informed consent, the pediatrician will give the subject designated number to enroll to the study. After gathering general information, medical history, and physical examination, the eligibility of participants will be assessed. The subject that fulfills the eligibility criteria will be enrolled in the study. All participants will collect stool sample or rectal swab to be tested with PCR test for EV71, CA (planned serotypes 16/10/6). If the result is positive, the sample will be further tested with genotype sequencing of EV71 and CoxA. For subject with respiratory symptom, skin lesion or encephalitis, extra PCR testing will be collected for PCR testing. Blood sample will also be collected from all subjects. Only 20 subjects with positive PCR result that will be tested for SVNT and PRNT. Two weeks following participant recruitment, study staff will contact the participant by phone and document the outcome of the disease as well the subject's condition.
Participants with clinically diagnosed cases of HFMD will be enrolled during the epidemic season within one year or earlies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically diagnosed HFMD children of either sex, aged 6 months - 18 years old in the study sites
Diagnostic Test: PCR
PCR test for EV71, CA16, CA10, or CA6
To identify the pathogens (EV71, CA16, CA10, and CA6) in clinically diagnosed HFMD childrenCA16, CA10, or CA6
Proportions of clinically diagnosed HFMD children who are PCR- positive for EV71, CA16, CA10, or CA6
Time frame: 12 months
To describe the clinical manifestation (symptom and severity etc.) of clinically diagnosed HFMD children
Distribution of HFMD symptoms and disease severity per predefined age groups, gender group (male and female), region group (urban and rural) and enterovirus type (EV71, CA16, CA10, CA6 and others) group.
Time frame: 12 months
To describe the genotypes of HFMD cases caused by EV71, CA16, CA10, and CA6
Frequency of the genotypes of EV71, CA16, CA10 or CA6 in PCR- positive cases
Time frame: 12 months
To investigate role of previous infection of enterovirus EV71, coxsackie virus
Proportions of participants who have previous infection (SVNT, and PRNT) of EV71, Coxsackie virus
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2024; primary completion for Jun 2025, 16 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hand, Foot and Mouth Disease →