Trials / Completed
CompletedNCT05727215
Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age
Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age. Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.
Detailed description
This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SARS-CoV-2 subunit protein recombinant vaccine | SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma |
Timeline
- Start date
- 2023-02-28
- Primary completion
- 2024-02-22
- Completion
- 2024-03-18
- First posted
- 2023-02-14
- Last updated
- 2025-06-03
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05727215. Inclusion in this directory is not an endorsement.