Calendario›SNY›Meningococcal
Meningococcal
A Phase I, Randomized, Modified Single-blind, Active-controlled (Infants Only), Four-stage, Step-down, Comparative, Multi-center Study
Ensayo de Sanofi en Meningococcal Immunization (del registro, en inglés).
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 285
- Fin del objetivo primario
- ago 2008
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en jul 2006.
Qué mide
Presence of solicited injection site reactions (ie, prelisted in the participant's diary card [DC] and in the electronic case report form [eCRF]) occurring up to 7 days after injection (Up to 7 days after injection) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe study will include groups of adults, toddlers, and infants who will receive different formulations of TetraMen-T, and one group of infants who will receive a control vaccine, Menjugate®. The primary objectives and their endpoints will be assessed in infants who receive TetraMen-T. The secondary objectives and their endpoints will be assessed only in the subset of infants who receive a booster dose of TetraMen-T. Primary objectives: 1. To describe the safety profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg olysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with djuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered concomitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®). 2. To describe the immunogenicity profile in infants following three injections of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), administered on comitantly with routine vaccines (Pentacel®, Prevnar®, and Engerix-B®). Secondary objectives: 1. To describe the safety profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per erogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age. 2. To describe the immunogenicity profile in a subset of infants following a booster dose of TetraMen-T, either a low-dose formulation (2 µg polysaccharide per serogroup without adjuvant), a low-dose adjuvanted formulation (2 µg polysaccharide per serogroup with adjuvant), or a high-dose formulation (10 µg polysaccharide per serogroup without adjuvant), at 13 months of age.
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| Isatuximab IV · IRAKLIA | Fase 3 | En marcha, sin reclutar | nov 2024 (real) |
Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06165276), actualizada en dic 2023.