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Low dose RSV-F Vaccine with…
RSV-F Vaccine and Influenza Vaccine Co-Administration Study in the Elderly
Ensayo de NOVAVAX INC en Infeccion por virus respiratorio sincitial.
Más ensayos de: Infección por virus respiratorio sincitial.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 220
- Centros
- 4
- Fin del objetivo primario
- jul 2013
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, triple ciego. Comenzó en oct 2012.
Qué mide
Assessment of Safety (del registro, en inglés) (del dia 0 al dia 364)
Cómo lo describe el promotor
En el documentoEn inglés, del registroUp to 220 eligible subjects will be enrolled into one of five treatment groups. It is anticipated that some of the randomized study subjects may not complete the study; subjects who withdraw or are discontinued, will not be replaced. Randomization will be stratified by age (60 to \<75 years and ≥ 75 years) in order to distribute the proportion of such persons in each age group equally across treatment groups. Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A rescue dose of the licensed TIV will be provided to subjects in all groups except the placebo group on Day 28, the placebo group will receive saline. For each subject, study follow-up will span approximately one year from the first immunization (on Day 0) for all subjects.
Más ensayos de NVAX
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|---|---|---|---|
| NVX-CoV2705 · COVID-19 | Fase 4 | En marcha, sin reclutar | nov 2026 (prevista) |
| CIC Vaccine Co-formulated tNIV2 | Fase 3 | Completado | dic 2025 (real) |
| coformulated CIC Vaccine · CIC | Fase 2/3 | Retirado antes de empezar | nov 2025 (prevista, ya pasada: sin actualizar en el registro) |
| tNIV 1 and Matrix-M Adjuvant | Fase 2/3 | Retirado antes de empezar | feb 2025 (real) |
| SHIELD | Fase 4 | Completado | dic 2024 (real) |
| NVX-CoV2705 Vaccine · COVID-19 | Fase 3 | Completado | oct 2024 (real) |
Todos los de NVAX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01709019), actualizada en mar 2014.