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Background: Children and adolescents are susceptible to influenza. Vaccination is the most important strategy for preventing influenza, yet there are few studies on the immunogenicity and safety of quadrivalent inactivated influen...
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Background: Children and adolescents are susceptible to influenza. Vaccination is the most important strategy for preventing influenza, yet there are few studies on the immunogenicity and safety of quadrivalent inactivated influenza vaccine (QIV) containing two A strains (H1N1 and H3N2) and two B lineages (Victoria and Yamagata). Therefore, to further clarify the immunogenicity and safety of QIV in children and adolescents, a meta-analysis was performed to provide a reference for the development of influenza prevention strategies.
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BackgroundAlthough children with acute lymphoblastic leukemia (ALL) mount immune responses after vaccination with the trivalent influenza vaccine (TIV), these responses are lower compared to controls. Recently, a high dose (HD) TI...
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BackgroundAlthough children with acute lymphoblastic leukemia (ALL) mount immune responses after vaccination with the trivalent influenza vaccine (TIV), these responses are lower compared to controls. Recently, a high dose (HD) TIV was found to increase the level of antibody response in elderly patients compared to the standard dose (SD) TIV. We hypothesized that the HD TIV would be well-tolerated and more immunogenic compared to the SD TIV in pediatric subjects with ALL.
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BackgroundEach year, an influenza B strain representing only one influenza B lineage is included in the trivalent inactivated influenza vaccine (IIV3); a mismatch between the selected lineage and circulating viruses can result in ...
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BackgroundEach year, an influenza B strain representing only one influenza B lineage is included in the trivalent inactivated influenza vaccine (IIV3); a mismatch between the selected lineage and circulating viruses can result in suboptimal vaccine effectiveness. We modeled the added potential public health impact of a quadrivalent inactivated influenza vaccine (IIV4) that includes strains from both influenza B lineages compared to IIV3 on influenza-associated morbidity and mortality in Thailand.
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The trivalent inactivated influenza vaccine Fluarix? is licensed in the US for adults and children from 3 years old. This randomized observer-blind study (NCT00764790) evaluated Fluarix? at two doses; 0.25 ml (Flu-25) and 0.5 ml (...
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The trivalent inactivated influenza vaccine Fluarix? is licensed in the US for adults and children from 3 years old. This randomized observer-blind study (NCT00764790) evaluated Fluarix? at two doses; 0.25 ml (Flu-25) and 0.5 ml (Flu-50) in children aged 6-35 months. The primary objective was to demonstrate immunogenic non-inferiority vs. a control vaccine (Fluzone?; 0.25 ml). Children received Flu-25 (n = 1107), Flu-50 (n = 1106) or control vaccine (n = 1104) at Day 0 and for unprimed children, also on Day 28. Serum hemagglutination-inhibition titers were determined pre-vaccination and at Day 28 (primed) or Day 56 (un-primed). Non-inferiority was assessed by post-vaccination geometric mean titer (GMT) ratio, (upper 95% confidence interval [CI] ≤ 1.5) and difference in seroconversion rate (upper 95% CI ≤ 10%). Reactogenicity/ safety was monitored. The immune response to Flu-50 met all regulatory criteria. Indicated by adjusted GMT ratios [with 95% CI], the criteria for non-inferiority of Flu-50 vs. control vaccine were reached for the B/Florida strain (1.13 [1.01-1.25]) but not for the A/Brisbane/H1N1 (1.74 [1.54-1.98]) or A/Uruguay/H3N2 (1.72 [1.57-1.89]) strains. In children aged 18-35 months similar immune responses were observed for Flu-50 and the control vaccine. Flu-50 induced a higher response than Flu-25 for all strains. Temperature (≥37.5°C) was reported in 6.2%, 6.4%, and 6.6% of the Flu-25, Flu-50, and control group, respectively. Reactogenicity/safety endpoints were within the same range for all vaccines. In children aged 6-35 months, immune responses with Flu-50 fulfilled regulatory criteria but did not meet the predefined criteria for non-inferiority vs. control. This appeared to be due to differences in immunogenicity in children aged <18 months.
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A trivalent inactivated influenza vaccine (CSL's TIV, CSL Limited) was licensed under USA accelerated approval regulations for use in persons >= 18 years. We performed a randomized, observer-blind study to assess the safety and im...
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A trivalent inactivated influenza vaccine (CSL's TIV, CSL Limited) was licensed under USA accelerated approval regulations for use in persons >= 18 years. We performed a randomized, observer-blind study to assess the safety and immunogenicity of CSL's TIV versus an established US-licensed vaccine in a population >= 6 months to <18 years of age. Subjects were stratified as follows: Cohort A (>= 6 months to <3 years); Cohort B (>= 3 years to <9 years); and Cohort C (>= 9 years to <18 years). The subject's age and influenza vaccination history determined the dosing regimen (one or two vaccinations). Subjects received CSL's TIV (n=739) or the established vaccine (n=735) in the autumn of 2009. Serum hemagglutination-inhibition titers were determined pre-vaccination and 30 days after the last vaccination. No febrile seizures or other vaccine-related SAEs were reported. After the first vaccination for Cohorts A and B, respectively, the relative risks of fever were 2.73 and 2.32 times higher for CSL's TIV compared to the established vaccine. Irritability and loss of appetite (for Cohort A) and malaise (for Cohort B) were also significantly higher for CSL's TIV compared to the established vaccine. Post-vaccination geometric mean titers (GMTs) for CSL's TIV versus the established vaccine were 385.49 vs. 382.45 for H1N1; 669.13 vs. 705.61 for H3N2; and 100.65 vs. 93.72 for B. CSL's TIV demonstrated immunological non-inferiority to the established vaccine in all cohorts. (C) 2014 Elsevier Ltd. All rights reserved.
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Background: Acute otitis media (AOM) is a frequent complication of influenza in children, and influenza vaccination helps protect against influenza-associated AOM. A live attenuated influenza vaccine (LAIV) approved for eligible c...
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Background: Acute otitis media (AOM) is a frequent complication of influenza in children, and influenza vaccination helps protect against influenza-associated AOM. A live attenuated influenza vaccine (LAIV) approved for eligible children aged ≥2 years for the prevention of influenza also effectively reduces influenza-associated AOM. However, the annual effectiveness of LAIV against all-cause AOM is unknown. Methods: AOM rates in children aged 6-83 months from 6 randomized, placebo-controlled trials and 2 randomized, inactivated influenza vaccinecontrolled trials were pooled and analyzed. To enable comparison with studies of AOM prevention by pneumococcal conjugate vaccines, 12-month effectiveness was calculated assuming that LAIV had no effect outside of influenza seasons. Results: During influenza seasons, LAIV efficacy compared with placebo against all-cause AOM in children aged 6-71 months (N = 9497) was 12.4% (95% confidence interval [CI]: 2.0%, 21.6%) in year 1. In year 2, the efficacy in children aged 18-83 months (N = 4142) was 6.2% (95% CI: -12.4%, 21.7%). Compared with inactivated influenza vaccine, the efficacy of LAIV in children aged 6-71 months (N = 9901) against febrile all-cause AOM was 9.7% (95% CI: -2.1%, 20.1%). The estimated 12-month effectiveness of LAIV compared with placebo against all-cause AOM was 7.5% (95% CI: -2.4%, 16.2%). Conclusions: LAIV reduced the incidence of all-cause AOM compared with placebo in children. The estimated 12-month effectiveness of LAIV was comparable with 7-valent pneumococcal conjugate vaccine. The effects of the vaccines will overlap somewhat; however, because pneumococcal conjugate vaccines only prevent a fraction of all pneumococcal AOM and influenza-associated AOM can be caused by other pathogens, LAIV could further reduce the incidence of AOM in children.
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We evaluated the risk of hospitalization for sickle cell crisis (SCC) following influenza vaccination (trivalent inactivated vaccine, TIV) in adults with sickle cell disease. The cohort consisted of all adults aged 18years and old...
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We evaluated the risk of hospitalization for sickle cell crisis (SCC) following influenza vaccination (trivalent inactivated vaccine, TIV) in adults with sickle cell disease. The cohort consisted of all adults aged 18years and older who had a diagnosis of sickle cell disease in the Vaccine Safety Datalink from 1991 to 2006. The outcome measure was any hospitalization for SCC with the main exposure being influenza vaccine. We used a self controlled case series design to compare the incidence rates ofhospitalization for SCC during the exposed and unexposed periods after TIV. No significant association between influenza vaccination and hospitalization for sickle cell crisis was found (IRR ratio 0.92, 95% confidence limits 0.66-1.28). These results provide evidence that the seasonal influenza vaccine is safe as recommended in adults who are at high risk for complications of influenza sequelae due to sickle cell disease.
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Background. Influenza is a significant cause of morbidity, and vaccination is the preferred preventive strategy. Data regarding the preferred influenza vaccine type among adults are limited.Methods. The effectiveness of 2 currentl...
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Background. Influenza is a significant cause of morbidity, and vaccination is the preferred preventive strategy. Data regarding the preferred influenza vaccine type among adults are limited.Methods. The effectiveness of 2 currently available influenza vaccines LAIV and TIV in preventing influenza-like illness (ILI) was compared among US military members (aged 18-49 years) during 3 consecutive influenza seasons (2006-2009). ILI, influenza, and pneumonia events post-vaccination were compared between vaccine types using Cox proportional hazard models adjusted for sociodemographic factors, occupation, and geographic area.Results. A total of 41 670 vaccination events were evaluated, including 28 929 during 2 "well-matched" seasons (2006-2007 and 2008-2009: LAIV n = 22 734, TIV n = 6195) and 12 741 during a suboptimally matched season due to mild antigenic drift (2007-2008: LAIV n = 9447, TIV n = 3294). ILI crude incidence rates for LAIV and TIV were 139 and 127 cases per 1000 person-seasons for the well-matched seasons, respectively, and 150 and 165 cases per 1000 person-seasons for the suboptimally matched season, respectively. In the multivariable models, there were no differences in ILI events by vaccine type (well-matched seasons: hazard ratio [HR], 0.97; 95% confidence interval [CI],. 90-1.06; suboptimally matched season: HR, 1.00; 95% CI,. 90-1.11). There were also no differences in influenza and/or pneumonia events by vaccine group.Conclusions. Between 2006 and 2009, TIV and LAIV had similar effectiveness in preventing ILI and influenza/pneumonia events among healthy adults.
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The purpose of this statement is to update recommendations for routine use of trivalent seasonal influenza vaccine and antiviral medications for the prevention and treatment of influenza in children. The key points for the upcomin...
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The purpose of this statement is to update recommendations for routine use of trivalent seasonal influenza vaccine and antiviral medications for the prevention and treatment of influenza in children. The key points for the upcoming 2012-2013 season are: (1) this year 's trivalent influenza vaccine contains A/California/7/2009 (H1N1)-like antigen (derived from influenza A [H1N1] pdm09 [pH1N1] virus); A/Victoria/361/2011 (H3N2)-like antigen; and B/Wisconsin/1/2010-like antigen (the influenza A [H3N2] and B antigens differ from those contained in the 2010-2011 and 2011-2012 seasonal vaccines); (2) annual universal influenza immunization is indicated; and (3) an updated dosing algorithm for administration of influenza vaccine to children 6 months through 8 years of age has been created. Pediatricians, nurses, and all health care personnel should promote influenza vaccine use and infection control measures. In addition, pediatricians should promptly identify influenza infections to enable rapid treatment, when indicated, to reduce morbidity and mortality.
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Background: Nine randomized controlled clinical trials, including approximately 26,000 children aged 6 months to 17 years, have evaluated the efficacy of live attenuated influenza vaccine (LAIV) against culture-confirmed influenza...
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Background: Nine randomized controlled clinical trials, including approximately 26,000 children aged 6 months to 17 years, have evaluated the efficacy of live attenuated influenza vaccine (LAIV) against culture-confirmed influenza illness compared with placebo or trivalent inactivated influenza vaccine (TIV). The objective of the current analysis was to integrate available LAIV efficacy data in children aged 2-17 years, the group for whom LAIV is approved for use. Methods: A meta-analysis was conducted using all available randomized controlled trials and a fixed-effects model. Cases caused by drifted influenza B were analyzed as originally classified and with all antigenic variants classified as dissimilar. Results: Five placebo-controlled trials (4 were 2-season trials) and 3 single-season TIV-controlled trials were analyzed. Compared with placebo, year 1 efficacy of 2 doses of LAIV was 83% (95% CI: 78, 87) against antigenically similar strains; efficacy was 87% (95% CI: 78, 93), 86% (95% CI: 79, 91), and 76% (95% CI: 63, 84) for A/H1N1, A/H3N2, and B, respectively. Classifying B variants as dissimilar, efficacy against all similar strains was 87% (95% CI: 83, 91) and 93% (95% CI: 83, 97) against similar B strains. Year 2 efficacy was 87% (95% CI: 82, 91) against similar strains. Compared with TIV, LAIV recipients experienced 44% (95% CI: 28, 56) and 48% (95% CI: 38, 57) fewer cases of influenza illness caused by similar strains and all strains, respectively. LAIV efficacy estimates for children from Europe, the United States, and Middle East were robust and were similar to or higher than those for the overall population. Conclusions: In children aged 2-17 years, LAIV demonstrated high efficacy after 2 doses in year 1 and revaccination in year 2, and greater efficacy compared with TIV. This meta-analysis provides precise estimates of LAIV efficacy among the approved pediatric age group.
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