Viewing Study NCT06272253



Ignite Creation Date: 2024-05-06 @ 8:10 PM
Last Modification Date: 2024-10-26 @ 3:21 PM
Study NCT ID: NCT06272253
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-02-22
First Post: 2024-02-18

Brief Title: UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster Immunobridging Study in Adolescent Subjects
Sponsor: Dr Soetomo General Hospital
Organization: Dr Soetomo General Hospital

Study Overview

Official Title: Immunobridging Study Immunogenicity and Safety of INAVAC Vaksin Merah Putih - UNAIR SARS-CoV-2 Vero Cell Inactivated as Heterologue Booster in Adolescent Subjects in Indonesia
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is an open label trial There will only be 1 group in the study All subjects will receive INAVAC vaccine and be followed for 6 months

The vaccine will be administered intramuscularly This study will be started after the interim analysis of the phase III INAVAC trial in adolescent This study will have two interim and one full analysis reports
Detailed Description: This is an open label trial There will only be 1 group in the study All subjects will receive INAVAC vaccine and be followed for 6 months

The vaccine will be administered intramuscularly This study will be started after the interim analysis of the phase III INAVAC trial in adolescent This study will have two interim and one full analysis reports

Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise They will review the 7 and 28 days safety data following the vaccine and then the 3 and 6 months safety data The immunogenicity data will be evaluated until 6 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None