WHO ICTRP trial
SOBERANA PEDIATRIA
RPCEC00000374 · Registro Público Cubano de Ensayos Clínicos (RPCEC) · Not Recruiting
Key facts
| Trial ID | RPCEC00000374 |
|---|---|
| Public title | SOBERANA PEDIATRIA |
| Scientific title | Phase I-II study, sequential during phase I, open-label, adaptive and multicenter to evaluate the safety, reactogenicity and immunogenicity, of a heterologous two-dose schedule of the prophylactic anti-SARS vaccine candidate - CoV-2, FINLAY-FR- 2 and a dose of FINLAY-FR-1A, in Cuban children and… |
| Primary sponsor | Finlay Vaccine Institute (IFV) |
| Secondary sponsors | Not applicable |
| Registry | Registro Público Cubano de Ensayos Clínicos (RPCEC) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 1-2 |
| Countries | Cuba |
| Conditions | COVID-19 COVID-19 SARS-CoV2 ;Disease Prevention;Coronavirus Infections;SARS Virus;Coronaviridae Infections;Betacoronavirus;COVID-19;SARS-CoV2 |
| Interventions | Experimental Group: FINLAY-FR-2 + FINLAY-FR-1A. FINLAY-FR-2: 25 µg of RBD-TT, by intramuscular route, 0.5 mL, in scheme 0 - 28 days. FINLAY-FR-1A: 50 µg of d-RBD + Aluminum Hydroxide Gel, by intramuscular route, 0.5 mL as dose booster 56… |
| Registration date | Oct 6, 2021 |
| Target size | 350 |
| Secondary IDs | IFV/COR/12 |
| Registry page | rpcec.sld.cu |
At a glance
- No Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: