- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05166031
Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine
29 de diciembre de 2021 actualizado por: Fidec Corporation
A Phase III Study to Evaluate the Immunogenicity and Safety of Concomitant Administration of Two Doses of a Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine in Healthy Infants
The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months who have never received vaccination against poliomyelitis.
Descripción general del estudio
Tipo de estudio
Intervencionista
Fase
- Fase 3
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 mes a 2 meses (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Infants aged 8 weeks (-1, + 2 weeks) with birth weight >2,500 gm.
- Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject to be in the study as established by the medical history and physical examination.
- Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.
Exclusion Criteria:
- Infants who have received previous vaccination according to the National Immunization Program (NIP) (i.e. vaccination against poliomyelitis and/or receipt of diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b [DTPw-HB-Hib vaccine]).
- Infants with anyone under 10 years of age in their household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic NIP.
- Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
- Infants having a member of their household (living in the same house or apartment unit) who has received oral polio vaccine (OPV) in the previous 3 months before study vaccine administration.
- Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
- Family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
- Known allergy to any component of the study vaccines or to any antibiotics, that share molecular composition with the nOPV2 vaccines.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
- Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: bOPV dose
Naïve infants to receive two doses of bOPV at 2 and 3 months of age.
|
Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.
|
Comparador activo: nOPV2 dose
Naïve infants to receive two doses of nOPV2 at 2 and 3 months of age.
|
Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.
|
Experimental: bOPV + nOPV2 dose
Naïve infants to receive two doses of nOPV2 and bOPV at 2 and 3 months of age.
|
Approximately 265 subjects will receive 2 doses of bOPV, nOPV2 or bOPV + nOPV2 per arm separated by 28 days between doses.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Seroconversion rate
Periodo de tiempo: 2 months
|
Assessment and comparison of seroconversion rate to poliovirus types 1, 2 and 3 28 days following co-administration of two doses of nOPV2 and bOPV with two doses of nOPV2 or two doses of bOPV
|
2 months
|
Incidence of serious adverse reactions (SARs) , important medical reactions (IMRs) and severe solicited adverse reactions (ARs)
Periodo de tiempo: 6 months
|
Number of serious adverse reactions, important medical reactions and severe solicited adverse reactions following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Immunogenicity to poliovirus type 2
Periodo de tiempo: 2 months
|
Assessment and comparison of geometric mean neutralizing antibody titers against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
|
2 months
|
Immunogenicity to poliovirus type 2
Periodo de tiempo: 2 months
|
Assessment and comparison of seroconversion rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
|
2 months
|
Immunogenicity to poliovirus type 2
Periodo de tiempo: 2 months
|
Assessment and comparison of seroprotection rate against poliovirus type 2 following administration of nOPV2 with co-administration of nOPV2 and bOPV
|
2 months
|
Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Periodo de tiempo: 2 months
|
Assessment and comparison of the seroprotection rates against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV.
|
2 months
|
Assessment and comparison of immunogenicity to poliovirus type 1 and 3
Periodo de tiempo: 2 months
|
Assessment and comparison of the geometric mean neutralizing against poliovirus types 1 and 3 following administration of bOPV with co-administration of nOPV2 and bOPV.
|
2 months
|
Assesment of SAEs, IMEs and any AEs
Periodo de tiempo: 6 months
|
Number, severity and causality of any serious adverse event (SAE), any solicited AE, any unsolicited AE and any important medical events (IME) following co-administration of nOPV2 and bOPV in comparison with nOPV2 or bOPV
|
6 months
|
Assessment and comparison of viral shedding
Periodo de tiempo: 1 month
|
Assessment and comparison of viral shedding in stool at fixed time points following administration of nOPV2, bOPV or the co-administration of nOPV2 and bOPV.
|
1 month
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Anticipado)
1 de diciembre de 2020
Finalización primaria (Anticipado)
1 de abril de 2021
Finalización del estudio (Anticipado)
18 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
26 de octubre de 2020
Primero enviado que cumplió con los criterios de control de calidad
8 de diciembre de 2021
Publicado por primera vez (Actual)
21 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
29 de diciembre de 2021
Última verificación
1 de diciembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Enfermedades Neuromusculares
- Infecciones del Sistema Nervioso Central
- Infecciones por enterovirus
- Infecciones por Picornaviridae
- Enfermedades de la médula espinal
- Mielitis
- Poliomielitis
Otros números de identificación del estudio
- nOPV2-001-ABMG
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre bOPV and nOPV2
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International Centre for Diarrhoeal Disease Research...Centers for Disease Control and Prevention; Government of BangladeshAún no reclutando
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China National Biotec Group Company LimitedPeking University; Hubei Provincial Center for Disease Control and Prevention; Shaanxi... y otros colaboradoresTerminadoVacunación | Reacción - VacunaPorcelana
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Fidec CorporationBill and Melinda Gates FoundationActivo, no reclutando
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Aga Khan UniversityNational Institutes of Health (NIH); Centers for Disease Control and Prevention; World Health OrganizationTerminado
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Sinovac Biotech Co., LtdTerminado
-
Fidec CorporationBill and Melinda Gates FoundationTerminadoPoliomielitisRepública Dominicana
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Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, BangladeshTerminado
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Cancer Institute and Hospital, Chinese Academy...Guangxi Center for Disease Control and PreventionDesconocido
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Centers for Disease Control and PreventionInternational Centre for Diarrhoeal Disease Research, BangladeshTerminadoPoliomielitisBangladesh
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University of VirginiaBill and Melinda Gates Foundation; International Centre for Diarrhoeal Disease...DesconocidoEliminación del virus de la vacunaBangladesh