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NCT06272253
UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects
EARLY_PHASE1 trial testing INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg in COVID-19 Pandemic in 250 participants. Status unknown.
19 March 2024
Quick facts
| Lead sponsor | Dr. Soetomo General Hospital |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 250 |
| Start date | 19 September 2023 |
| Primary completion | 19 March 2024 |
| Estimated completion | 19 July 2024 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg
Conditions studied
- COVID-19 Pandemic — all drugs for COVID-19 Pandemic →
- COVID-19 Vaccines — all drugs for COVID-19 Vaccines →
Sponsor
Dr. Soetomo General Hospital
Who can join
Adults 12 to 17, any sex, with COVID-19 Pandemic or COVID-19 Vaccines. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06272253
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg
Trials testing the same drug.
- NCT06259578 — UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study) · EARLY_PHASE1 · unknown
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Currently open trials in the same condition.
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- NCT06927622 — Corona Virus Disease 2019 Cohort Study · recruiting
- NCT05096260 — Getting to Yes, Michigan! (G2YMI) · NA · active not recruiting
- NCT06208943 — Neural and Cognitive Consequences of COVID-19 Survival · recruiting
Other Dr. Soetomo General Hospital trials
Trials by the same sponsor.
- NCT06935630 — Comparison of The Effect of 5-MTHF and Folic Acid Supplementation in Increasing Red Blood Cell Folate in Pregnant Women · NA · recruiting
- NCT06259578 — UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study) · EARLY_PHASE1 · unknown
- NCT07328113 — Interleukin-6 and Thyroid Dysfunction in Hemodialysis Patients · completed
- NCT06282692 — INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old · Phase 3 · unknown
- NCT07266961 — Low-BFR vs Moderate-Intensity Resistance Training on Cardiorespiratory Fitness in Elderly Women · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06272253 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Soetomo General Hospital
- Last refreshed: 22 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06272253.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing