Last reviewed · How we verify
NCT06282692
INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old
Phase 3 trial testing INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg in COVID-19 Pandemic in 400 participants. Status unknown.
19 May 2024
Quick facts
| Lead sponsor | Dr. Soetomo General Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 400 |
| Start date | 19 June 2023 |
| Primary completion | 19 May 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 — full drug profile →
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, female only, 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, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06282692
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19 Pandemic
Currently open trials in the same condition.
- NCT05825651 — Long COVID and Its Associations With Health Outcomes in Older Adults · active not recruiting
- 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
- NCT06272253 — UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects · EARLY_PHASE1 · 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 NCT06282692 (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: 28 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/NCT06282692.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing