International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
Tahapan Penelitian : Recruit
Sponsor:
• National Institute of Health Research and Development (NIHRD), Indonesia • The National Institute of Allergy and Infectious Diseases, United States
Mitra Pelaksana:
INA-RESPOND, RSU Kab Tangerang, RSUD TC Hillers
No Registry
INA-GDN05DZ
Tanggal Input Registry : 01-11-2021
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 18-08-2021 |
| Outcome Primer | Anti-S Ab at 2 months after completion of vaccine regimen. |
| Outcome Skunder | 1. Anti-S Ab at different, specified time points 2. Anti-S Ab in predefined subgroups. 3. Sequencing to characterize SARS-CoV-2 variants. 4. Anti-S Ab at 2 months post-vaccine regimen. 5. Levels of anti-nucleocapsid Ab. |
| Descriptive Information | |
| Judul Penelitian Popular | International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE) |
| Judul Penelitian Ilmiah | International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE) |
| Jenis Penelitian | Observational |
| Intervensi | Tidak ada intervensi |
| Jumlah Subyek Penelitian | 500 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1.18 years of age or older. 2.Ability to provide informed consent. 3.Enrollment within one day (before or after) of receipt of COVID-19 vaccine. 4.Willingness to be evaluated (including collection of blood and nasopharyngeal samples) during the prescribed study visits and/or during acute illness consistent with SARS-CoV-2 infection during the study period. 5.Willingness to allow storage of biological samples for research testing as outlined in this protocol.Exclusion Criteria: Individuals meeting any of the following criteria will be excluded from study participation: 1.Any acute or chronic condition that, in the opinion of the investigator, is a contraindication to participation in this study; for example, acute febrile illness. 2.Inability to comply with study visits. 3.Current participation in a COVID-19 vaccine study. |
| Administrative Information | |
| Nomor Persetujuan Etik | No. 445/009-KEP-RSUTNG tertanggal 8 Juli 2021 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | InVITE 01 |
| Contact Person | dr. M. Karyana, M.Kes |