International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE)

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
INA-RESPOND, RSU Kab Tangerang, RSUD TC Hillers
No Registry
INA-GDN05DZ
Tanggal Input Registry : 01-11-2021

18-08-2021
Anti-S Ab at 2 months after completion of vaccine regimen.
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.
 
International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
International study on COVID-19 Vaccine to assess Immunogenicity, Reactogenicity and Efficacy (InVITE)
Observasional
Tidak ada intervensi
500
 

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.
 
No. 445/009-KEP-RSUTNG tertanggal 8 Juli 2021
Tidak berlaku
Tidak berlaku
InVITE 01
dr. M. Karyana, M.Kes