Seroprevalence of Hepatitis A in Indonesia part of "Seroprevalence of Hepatitis A in 3 South East Asian Countries: Indonesia, The Philippines And Vietnam"
Tahapan Penelitian : Initial
Sponsor:
GlaxoSmithKline Biologicals SA
Mitra Pelaksana:
Division of Gastrohepatology, Department of Child Health Faculty of Medicine Universitas Padjadjaran - Dr. Hasan Sadikin General Hospital Bandung, Indonesia
No Registry
INA-CLYNAA
Tanggal Input Registry : 15-06-2021
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-07-2021 |
| Outcome Primer | To assess age prevalence trend of anti-HAV antibodies from two contrasting geographical areas in the population from Indonesia |
| Outcome Skunder | • To estimate the age at midpoint of population immunity (AMPI) in the study population from Indonesia and area of study • To determine the strength of association of the known risk factors for HAV seropositivity in the study population |
| Descriptive Information | |
| Judul Penelitian Popular | Seroprevalence of Hepatitis A in Indonesia part of "Seroprevalence of Hepatitis A in 3 South East Asian Countries: Indonesia, The Philippines And Vietnam" |
| Judul Penelitian Ilmiah | Seroprevalence of Hepatitis A in Indonesia part of "Seroprevalence of Hepatitis A in 3 South East Asian Countries: Indonesia, The Philippines And Vietnam" |
| Jenis Penelitian | Observasional |
| Intervensi | This is study without intervention |
| Jumlah Subyek Penelitian | 1280 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Between 1-80 years of age 2. Willing to participate and provide Informed consent (and attestation for minors according to local good research practices) by participant or parent and/ or legal guardian for children. 3. Being resident (living during the last 6 months) in the selected geographic areaExclusion Criteria: 1. Children in care 2. Receipt of immune globulins, blood or blood-derived products in last 3 months. 3. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating blood drawing. 4. Attending to a health care institution due to gastrointestinal symptoms or icterical in the last 8 weeks 5. Individuals diagnosed Immunodeficiency condition 6. Individuals diagnosed with Terminal or psychiatric illness 7. Child, parent or other family member living the same household already enrolled as participant in this study. |
| Administrative Information | |
| Nomor Persetujuan Etik | 409/UN6.KEP/EC/2021 |
| Nomor Persetujuan Material Transfer Agreement | Not Applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | Not Applicable |
| Other Study ID Numbers | EPI-HAV-013 BOD APA SUPP |
| Contact Person | Prof. Dr. Dwi Prasetyo dr.,Sp.A(K)., M.Kes; Yudith Setiati Ermaya dr., Sp.A(K)., M.Kes; Prof. Cissy B Kartasasmita dr., Sp.A(K)., MSc., PhD; Gustavo Hernandez-Suarez MD., MSc. |