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| Name | Class |
|---|---|
| Universitas Padjadjaran | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary dose of inactivated (Sinovac®) vaccine | Experimental | Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 subunit protein recombinant vaccine | Biological | SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of the candidate vaccine | Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2 | 14 days after booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositive rate of the candidate vaccine | Seropositive rate of neutralizing antibody | baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination |
| Seroconversion rate of the candidate vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eddy Fadlyana, MD | Universitas Padjadjaran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Universitas Padjadjaran | Bandung | West Java | 40161 | Indonesia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Seroconversion rate of neutralizing antibody
| baseline and 14 days after booster vaccination |
| Seropositive rate and GMT of candidate vaccine | Seropositive rate and GMT of IgG antibody (RBD) | baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination |
| Seroconversion rate of candidate vaccine | Seroconversion rate of IgG antibody (RBD) | baseline and 14 days after booster vaccination |
| Safety of the candidate vaccine | Percentage of subjects with solicited and unsolicited Adverse Events (AE) | 30 minutes, 7 days, 28 days, and until 12 months after booster vaccination |
| Serious Adverse Event (SAE) of the vaccine | Percentage of subjects with at least 1 SAE | until 12 months after booster vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |