Trials / Unknown
UnknownNCT06272253
UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects
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
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Dr. Soetomo General Hospital · Other Government
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg | Dose : 1 dose 0.5 ml containing 5 μg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride. |
Timeline
- Start date
- 2023-09-19
- Primary completion
- 2024-03-19
- Completion
- 2024-07-19
- First posted
- 2024-02-22
- Last updated
- 2024-02-22
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT06272253. Inclusion in this directory is not an endorsement.