Q3149749 (Q3149749): Difference between revisions
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(Created claim: summary (P836): Seasonal inactivated influenza vaccine (IVG) is currently recommended in children with chronic diseases with increased risk of severity (cardiovascular, neuromuscular, renal or immunological disorders and chronic respiratory disease). This regimen is based on studies of vaccine efficacy and effectiveness in preventing confirmed influenza infections. However, epidemiological and immunological studies suggest competitive interference between respi...) |
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Seasonal inactivated influenza vaccine (IVG) is currently recommended in children with chronic diseases with increased risk of severity (cardiovascular, neuromuscular, renal or immunological disorders and chronic respiratory disease). This regimen is based on studies of vaccine efficacy and effectiveness in preventing confirmed influenza infections. However, epidemiological and immunological studies suggest competitive interference between respiratory viruses, which could have a limited net impact of GIV versus acute respiratory infections (ARIs), so that while the vaccine can protect against influenza, other infections with different respiratory viruses may be increased. It is unclear whether this involves more or less mild episodes of disease or a shorter course of illness. To provide new scientific evidence to assist vaccination policies, we propose a randomised controlled clinical trial of VIG vs placebo in children with recurrent/severe ARI in the early years of life to (i) determine the net health effects measured as efficacy against seasonal ARIs, severity of symptoms and complications; and (ii) analyse whether GIV modifies the risk of influenza and other non-flu viral infections. Children with recurrent or severe ARI will be recruited for two years in accordance with the current regulations (Helsinki Declaration) and the standards of Good Clinical Practice. After parental consent, children will be randomly assigned to receive two doses of VIG or placebo prior to the flu season and will be followed with an app. (English) | |||||||||||||||
| Property / summary: Seasonal inactivated influenza vaccine (IVG) is currently recommended in children with chronic diseases with increased risk of severity (cardiovascular, neuromuscular, renal or immunological disorders and chronic respiratory disease). This regimen is based on studies of vaccine efficacy and effectiveness in preventing confirmed influenza infections. However, epidemiological and immunological studies suggest competitive interference between respiratory viruses, which could have a limited net impact of GIV versus acute respiratory infections (ARIs), so that while the vaccine can protect against influenza, other infections with different respiratory viruses may be increased. It is unclear whether this involves more or less mild episodes of disease or a shorter course of illness. To provide new scientific evidence to assist vaccination policies, we propose a randomised controlled clinical trial of VIG vs placebo in children with recurrent/severe ARI in the early years of life to (i) determine the net health effects measured as efficacy against seasonal ARIs, severity of symptoms and complications; and (ii) analyse whether GIV modifies the risk of influenza and other non-flu viral infections. Children with recurrent or severe ARI will be recruited for two years in accordance with the current regulations (Helsinki Declaration) and the standards of Good Clinical Practice. After parental consent, children will be randomly assigned to receive two doses of VIG or placebo prior to the flu season and will be followed with an app. (English) / rank | |||||||||||||||
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| Property / summary: Seasonal inactivated influenza vaccine (IVG) is currently recommended in children with chronic diseases with increased risk of severity (cardiovascular, neuromuscular, renal or immunological disorders and chronic respiratory disease). This regimen is based on studies of vaccine efficacy and effectiveness in preventing confirmed influenza infections. However, epidemiological and immunological studies suggest competitive interference between respiratory viruses, which could have a limited net impact of GIV versus acute respiratory infections (ARIs), so that while the vaccine can protect against influenza, other infections with different respiratory viruses may be increased. It is unclear whether this involves more or less mild episodes of disease or a shorter course of illness. To provide new scientific evidence to assist vaccination policies, we propose a randomised controlled clinical trial of VIG vs placebo in children with recurrent/severe ARI in the early years of life to (i) determine the net health effects measured as efficacy against seasonal ARIs, severity of symptoms and complications; and (ii) analyse whether GIV modifies the risk of influenza and other non-flu viral infections. Children with recurrent or severe ARI will be recruited for two years in accordance with the current regulations (Helsinki Declaration) and the standards of Good Clinical Practice. After parental consent, children will be randomly assigned to receive two doses of VIG or placebo prior to the flu season and will be followed with an app. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 14:36, 12 October 2021
Project Q3149749 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3149749 in Spain |
Statements
88,375.0 Euro
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176,750.0 Euro
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50.0 percent
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1 January 2019
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31 March 2022
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FUNDACION PARA EL FOMENTO DE LA INV. SANITARIA Y BIOMEDICA DE LA COMUNIDAD VALENCIANA (FISABIO)
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39°28'10.96"N, 0°22'34.82"W
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46250
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Actualmente se recomienda la vacuna inactivada antigripal (VIG) estacional en niños con enfermedades crónicas con aumento de riesgo de gravedad (trastornos cardiovasculares, neuromusculares, renales o inmunológicos y enfermedad respiratoria crónica). Esta pauta se basa en estudios de eficacia y efectividad de la vacuna para evitar infecciones gripales confirmadas. Sin embargo, hay estudios epidemiológicos e inmunológicos que sugieren una interferencia competitiva entre virus respiratorios, lo que podría dar un impacto neto limitado de la VIG frente a infecciones respiratorias agudas (IRA), de forma que si bien la vacuna puede proteger de la gripe, otras infecciones por distintos virus respiratorios pueden verse incrementadas. No está claro si esto implica episodios de enfermedad más o menos leves o un curso de enfermedad más corto. Para aportar nuevas pruebas científicas, que ayuden a las políticas de vacunación, proponemos un ensayo clínico controlado aleatorizado de la VIG vs placebo en niños con IRA recurrente/grave en los primeros años de vida para i) determinar los efectos netos de salud medidos como eficacia frente a las IRA estacionales, gravedad de los síntomas y complicaciones; y ii) analizar si la VIG modifica el riesgo de gripe y otras infecciones virales no gripales. Se reclutarán niños con IRA recurrente o grave durante dos años siguiendo la regulación vigente (Declaración de Helsinki) y las normas de Buena Práctica Clínica. Después de obtener el consentimiento de los padres, los niños serán asignados aleatoriamente a recibir dos dosis de VIG o placebo previo a la temporada gripal y serán seguidos con una app. (Spanish)
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Seasonal inactivated influenza vaccine (IVG) is currently recommended in children with chronic diseases with increased risk of severity (cardiovascular, neuromuscular, renal or immunological disorders and chronic respiratory disease). This regimen is based on studies of vaccine efficacy and effectiveness in preventing confirmed influenza infections. However, epidemiological and immunological studies suggest competitive interference between respiratory viruses, which could have a limited net impact of GIV versus acute respiratory infections (ARIs), so that while the vaccine can protect against influenza, other infections with different respiratory viruses may be increased. It is unclear whether this involves more or less mild episodes of disease or a shorter course of illness. To provide new scientific evidence to assist vaccination policies, we propose a randomised controlled clinical trial of VIG vs placebo in children with recurrent/severe ARI in the early years of life to (i) determine the net health effects measured as efficacy against seasonal ARIs, severity of symptoms and complications; and (ii) analyse whether GIV modifies the risk of influenza and other non-flu viral infections. Children with recurrent or severe ARI will be recruited for two years in accordance with the current regulations (Helsinki Declaration) and the standards of Good Clinical Practice. After parental consent, children will be randomly assigned to receive two doses of VIG or placebo prior to the flu season and will be followed with an app. (English)
12 October 2021
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Valencia
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Identifiers
PI18_01200
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