COVID-19 Pandemic Clinical Trial
Official title:
Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia
The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.
This is an open-label trial. There will be only one group in the study. This group will receive the INAVAC vaccine as a booster. The inclusion and exclusion criteria for the subjects are listed below. All subjects will be followed for 6 months. The vaccine will be administered intramuscularly. This study will have one interim and one full analysis report. A 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-day safety data following the vaccine, and then the 3 and 6-month safety data. The immunogenicity data will be evaluated for 6 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05197634 -
The Impact of Covid-19 Pandemic On The Children With Autism Spectrum Disorder
|
||
| Recruiting |
NCT05918939 -
UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)
|
Early Phase 1 | |
| Completed |
NCT05383560 -
Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults
|
Phase 2 | |
| Active, not recruiting |
NCT05125874 -
Clinical Study for Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Immunization
|
N/A | |
| Completed |
NCT05517148 -
Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction
|
N/A | |
| Completed |
NCT05552989 -
Towards Better Preparedness for Future Catastrophes - Local Lessons-learned From COVID-19
|
||
| Completed |
NCT05543551 -
Effects of Diagrammatic Breathing With and Without Resistance in Post Covid Patients on ADLs
|
N/A | |
| Active, not recruiting |
NCT06272253 -
UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects
|
Early Phase 1 | |
| Active, not recruiting |
NCT05585567 -
A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5
|
Early Phase 1 | |
| Active, not recruiting |
NCT05582746 -
COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement
|
N/A | |
| Not yet recruiting |
NCT05381883 -
Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments
|
N/A | |
| Recruiting |
NCT05062681 -
RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow
|
Phase 4 | |
| Completed |
NCT04697030 -
Burnout Among Adolescent Population During Covid-19 Lockdown in Pakistan
|
||
| Active, not recruiting |
NCT05419167 -
STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic
|
Phase 1 | |
| Terminated |
NCT05553964 -
SARS-CoV-2 OTC At Home Test
|
N/A | |
| Completed |
NCT05596032 -
Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
|
||
| Completed |
NCT05583812 -
A Study of FB2001 for Inhalation in Healthy Chinese Adults
|
Phase 1 | |
| Completed |
NCT05844410 -
Evaluation of Corticosteroids Use and Clinical Outcomes in Hospitalized COVID-19 Patients: A Retrospective Study
|
||
| Completed |
NCT05123573 -
Self-Perceived in Medical Students Undergoing Distance Learning
|
||
| Completed |
NCT05305300 -
A Phase I Study to Evaluate Safety, Tolerability, and Immunogenicity of a PIKA COVID-19 Vaccine in Healthy Individuals
|
Phase 1 |