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2.
PLoS One ; 17(11): e0273837, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36355793

RESUMO

BACKGROUND: The risk of hospitalization or death after influenza infection is higher at the extremes of age and in individuals with comorbidities. We estimated the number of hospitalizations with influenza and characterized the cumulative risk of comorbidities and age on severe outcomes in Mexico and Brazil. METHODS: We used national hospital discharge data from Brazil (SIH/SUS) from 2010-2018 and Mexico (SAEH) from 2010-2017 to estimate the number of influenza admissions using ICD-10 discharge codes, stratified by age (0-4, 5-17, 18-49, 50-64, and ≥65 years). Duration of hospital stay, admission to the intensive care unit (ICU), and in-hospital case fatality rates (CFRs) defined the severe outcomes. Rates were compared between patients with or without pre-specified comorbidities and by age. RESULTS: A total of 327,572 admissions with influenza were recorded in Brazil and 20,613 in Mexico, with peaks period most years. In Brazil, the median hospital stay duration was 3.0 days (interquartile range, 2.0-5.0), ICU admission rate was 3.3% (95% CI, 3.2-3.3%), and in-hospital CFR was 4.6% (95% CI, 4.5-4.7). In Mexico, the median duration of stay was 5.0 days (interquartile range, 3.0-7.0), ICU admission rate was 1.8% (95% CI, 1.6-2.0%), and in-hospital CFR was 6.9% (95% CI, 6.5-7.2). In Brazil, ICU admission and in-hospital CFR were higher in adults aged ≥50 years and increased in the presence of comorbidities, especially cardiovascular disease. In Mexico, comorbidities increased the risk of ICU admission by 1.9 (95% CI, 1.0-3.5) and in-hospital CFR by 13.9 (95% CI, 8.4-22.9) in children 0-4 years. CONCLUSION: The SIH/SUS and SAEH databases can be used to estimate hospital admissions with influenza, and the disease severity. Age and comorbidities, especially cardiovascular disease, are cumulatively associated with more severe outcomes, with differences between countries. This association should be further analyzed in prospective surveillance studies designed to support influenza vaccination strategy decisions.


Assuntos
Doenças Cardiovasculares , Influenza Humana , Adulto , Criança , Humanos , Influenza Humana/epidemiologia , Influenza Humana/complicações , Brasil/epidemiologia , Estudos Prospectivos , Doenças Cardiovasculares/complicações , México/epidemiologia , Hospitalização , Unidades de Terapia Intensiva , Hospitais
3.
Hum Vaccin Immunother ; 16(3): 623-629, 2020 03 03.
Artigo em Inglês | MEDLINE | ID: mdl-31526225

RESUMO

Vaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 - 7.7] vs. 3.4 [95% CI: 2.7 - 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 - 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Vacinas contra Influenza , Influenza Humana , Adolescente , Adulto , Anticorpos Antivirais , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Testes de Inibição da Hemaglutinação , Humanos , Imunogenicidade da Vacina , Lactente , Recém-Nascido , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Gravidez , Gestantes , Vacinas de Produtos Inativados/efeitos adversos
4.
Vaccine ; 37(13): 1885-1888, 2019 03 22.
Artigo em Inglês | MEDLINE | ID: mdl-30745147

RESUMO

BACKGROUND: A multi-season phase III trial conducted in the Northern and Southern Hemispheres demonstrated the efficacy of a quadrivalent split-virion inactivated influenza vaccine (IIV4) in children 6-35 months of age. METHODS: Data collected during the phase III trial were analysed to examine the vaccine efficacy (VE) of IIV4 in preventing laboratory-confirmed influenza in age subgroups and to determine the relative risk for IIV4 vs. placebo for severe outcomes, healthcare use, and parental absenteeism from work associated with laboratory-confirmed influenza. RESULTS: VE (95% confidence interval [CI]) to prevent laboratory-confirmed influenza due to any A or B strain was 54.76% (40.24-66.03%) for participants aged 6-23 months and 46.91% (23.57-63.53%) for participants aged 24-35 months. VE (95% CI) to prevent laboratory-confirmed influenza due to vaccine-similar strains was 74.51% (53.55-86.91%) for participants aged 6-23 months and 59.78% (19.11-81.25%) for participants aged 24-35 months. Compared to placebo, IIV4 reduced the risk (95% CI) by 31.28% (8.96-89.34%) for acute otitis media, 21.76% (6.46-58.51%) for acute lower respiratory infection, 40.80% (29.62-55.59%) for healthcare medical visits, 29.71% (11.66-67.23%) for parent absenteeism from work, and 39.20% (26.89-56.24%) for antibiotic use. CONCLUSION: In children aged 6-35 months, vaccination with IIV4 reduces severe outcomes of influenza as well as the associated burden for their parents and the healthcare system. In addition, vaccination with IIV4 is effective at preventing against influenza in children aged 6-23 and 24-35 months. TRIAL REGISTRATION: EudraCT no. 2013-001231-51.


Assuntos
Vacinas contra Influenza/imunologia , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Vacinas de Produtos Inativados/imunologia , Assistência Ambulatorial , Pré-Escolar , Feminino , Humanos , Lactente , Vacinas contra Influenza/administração & dosagem , Influenza Humana/complicações , Masculino , Avaliação de Resultados em Cuidados de Saúde , Aceitação pelo Paciente de Cuidados de Saúde , Vacinas de Produtos Inativados/administração & dosagem
5.
Hum Vaccin Immunother ; 15(4): 973-977, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30762467

RESUMO

A quadrivalent split-virion inactivated influenza vaccine (IIV4; Fluzone® Quadrivalent, Sanofi Pasteur) has been available in the US since 2013 for individuals aged ≥ 6 months. Here, we describe the results of an open-label, multicenter trial (WHO Universal Trial Number U1111-1143-8370) evaluating the immunogenicity and safety of IIV4 in Indian children aged 6-35 months and 3-8 years, adolescents aged 9-17 years, and adults aged ≥ 18 years (n = 100 per group). Post-vaccination hemagglutination inhibition titers for all strains in all age groups were ≥ 8 fold higher than at baseline (range, 8-51). At least 70% of participants in all age groups seroconverted or had a significant increase in titer for each strain. The most common solicited reactions were injection-site pain and tenderness, plus fever in participants 6-23 months and myalgia in older children and adolescents. All injection-site reactions and most systemic reactions were grade 1 or 2 and resolved within 3 days. Only three vaccine-related unsolicited adverse events were reported, all of which were grade 1 or 2 and transient. No immediate adverse events, adverse events leading to study discontinuation, adverse events of special interest, or serious adverse events were reported. This study showed that IIV4 was well tolerated and highly immunogenic in all age groups. This adds important data on the safety, tolerability, and immunogenicity of influenza vaccines in India.


Assuntos
Anticorpos Antivirais/sangue , Imunogenicidade da Vacina , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/imunologia , Injeções Intramusculares , Vírion/imunologia , Adolescente , Adulto , Criança , Pré-Escolar , Feminino , Humanos , Índia , Lactente , Influenza Humana/prevenção & controle , Masculino , Vacinação/métodos , Vacinas de Produtos Inativados/imunologia , Adulto Jovem
6.
Expert Rev Vaccines ; 17(1): 1-11, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29157068

RESUMO

INTRODUCTION: VaxigripTetra™ (IIV4; Sanofi Pasteur) is a quadrivalent split-virion influenza vaccine approved in Europe in 2016 for individuals ≥ 3 years of age. IIV4 builds on the well-established record of the trivalent split-virion influenza vaccine (Vaxigrip®). Areas covered: This literature review summarizes the rationale for developing quadrivalent influenza vaccines and discusses the phase III clinical trial results supporting the immunogenicity, safety, and tolerability of IIV4. Expert commentary: IIV4 is immunogenic and well tolerated. Adding a second B strain to the trivalent split-virion influenza vaccine provides a superior immune response for the additional strain but does not reduce the immune response for the three other strains or negatively affect the safety profile. By offering broader protection against co-circulating influenza B lineages, IIV4 has the potential to further reduce influenza-related morbidity and mortality beyond that achieved with trivalent vaccines.


Assuntos
Vírus da Influenza B/imunologia , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Humanos , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Influenza Humana/imunologia , Influenza Humana/virologia , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia
7.
Expert Rev Vaccines ; 16(6): 545-564, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-28460594

RESUMO

INTRODUCTION: Vaxigrip, a trivalent split-virion, inactivated vaccine available since 1968 has been in use longer than any other influenza vaccine. It is the most widely-used influenza vaccine, with more than 1.8 billion doses distributed in more than 120 countries. Areas covered: The significant body of evidence that confirms the efficacy, effectiveness, immunogenicity, and safety of Vaxigrip in healthy individuals of all ages and at-risk populations is summarized. The results from at least 15 randomized efficacy trials and 15 other studies have demonstrated that vaccination with Vaxigrip is efficacious against various clinical endpoints. It was estimated that more than 37 million laboratory-confirmed influenza episodes, 476,000 influenza-related hospitalizations, and 67,000 influenza-related deaths have been avoided by the more than 1.8 billion doses of Vaxigrip that have been distributed, emphasizing its important public health impact. Expert commentary: This strong evidence base in favor of Vaxigrip provides a robust foundation to support the implementation of the quadrivalent formulation. This quadrivalent formulation of Vaxigrip contains two A and two B influenza strains (VaxigripTetra), and has a similar immunogenicity and safety profile to the trivalent formulation while offering broader protection due to the addition of the second influenza B strain.


Assuntos
Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/imunologia , Influenza Humana/prevenção & controle , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Humanos , Resultado do Tratamento , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia
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