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Pneumococcal Conjugate Vaccine…
Study of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants
Ensayo de Sanofi en Pneumococcal Immunisation · Diphtheria Immunisation · Tetanus Immunisation · Pertussis Immunisation · Hepatitis B Immunisation · Haemophilus Influenzae Type b Immunisation · Polio Immunisation · Measles Immunisation · Rubella Immunisation · Varicella Immunisation · Mumps Immunisation (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 852
- Centros
- 57
- Fin del objetivo primario
- ago 2023
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en may 2020.
Qué mide
Number of Participants With Immediate Adverse Events (AEs) (Up to 30 minutes after each vaccination) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary objectives: * To assess the safety profile of each SP0202 formulation and Prevnar 13 in toddlers and infants (after each and any injection). * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in infants (Groups 5-8) * To assess the immune response (serotype specific IgG concentration) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in infants (Groups 5-8) Secondary objectives: * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of one dose in toddlers (Groups 1-4) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after the administration of 3 doses in a subset of infants (Groups 5-8) * To assess the immune response (serotype specific OPA titer) of the SP0202 formulations and Prevnar 13 1 month after administration of a 4-dose schedule in a subset of infants (Groups 5-8) * In toddlers: to describe the Ab responses against Pentacel antigens before and 1 month following injection of Pentacel * In infants: to describe the Ab responses against antigens of the routine pediatric vaccines (Pentacel, RotaTeq, ENGERIX-B, M-M-RII, and VARIVAX) when administered concomitantly with either SP0202 or Prevnar 13 (at pre-Dose 1 (as applicable) for RotaTeq, Diphteria, Tetanus and Pertussis antigens; at PD3 for ENGERIX-B, RotaTeq, and Pentacel; at PD4 for M-M-RII and VARIVAX\])
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04398706), actualizada en sep 2025.