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High-dose inactivated influenza vaccine has been shown to provide protection against influenza that is superior to that with the standard dose. However, data from individually randomized trials on the effectiveness of the high-dose vaccine against severe outcomes are limited. In this pragmatic, open-label, randomized, controlled trial conducted in Denmark during the 2022-2023, 2023-2024, and 2024-2025 influenza seasons, we assigned older adults (≥65 years of age) to receive the high dose of the inactivated influenza vaccine or the standard dose. Data collection relied on nationwide administrative health registries. The primary end point was hospitalization for influenza or pneumonia that occurred from 14 days after vaccination through May 31 of the following year. Of the 332,438 participants who underwent randomization, 166,218 were assigned to receive the high-dose vaccine and 166,220 to receive the standard-dose vaccine. The mean (±SD) age of the participants was 73.7±5.8 years, and 161,538 participants (48.6%) were women. A primary end-point event occurred in 1138 participants (0.68%) in the high-dose group and in 1210 (0.73%) in the standard-dose group (relative vaccine effectiveness, 5.9%; 95.2% confidence interval [CI], -2.1 to 13.4; P = 0.14). Hospitalization for influenza occurred in 0.06% of the participants in the high-dose group and in 0.11% of those in the standard-dose group (relative vaccine effectiveness, 43.6%; 95.2% CI, 27.5 to 56.3); hospitalization for pneumonia occurred in 0.63% and 0.63%, respectively (relative effectiveness, 0.5%; 95.2% CI, -8.6 to 8.8); hospitalization for cardiorespiratory disease in 2.25% and 2.38% (relative effectiveness, 5.7%; 95.2% CI, 1.4 to 9.9); hospitalization for any cause in 9.38% and 9.58% (relative effectiveness, 2.1%; 95.2% CI, -0.1 to 4.3), and death from any cause in 0.67% and 0.66% (relative effectiveness, -2.5%; 95.2% CI, -11.6 to 5.9). The incidence of serious adverse events was similar in the two groups. In this trial, a high-dose inactivated influenza vaccine did not result in a significantly lower incidence of hospitalization for influenza or pneumonia than a standard dose among older adults. (Funded by Sanofi; DANFLU-2 ClinicalTrials.gov number, NCT05517174; EU Clinical Trials Register number, 2022-500657-17-00.).

Purpose Although patients with SARS-CoV-2 infection have several risk factors for ventilator-associated lower respiratory tract infections (VA-LRTI), the reported incidence of hospital-acquired infections is low. We aimed to determine the relationship between SARS-CoV-2 pneumonia, as compared to influenza pneumonia or no viral infection, and the incidence of VA-LRTI. Methods Multicenter retrospective European cohort performed in 36 ICUs. All adult patients receiving invasive mechanical ventilation > 48 h were eligible if they had: SARS-CoV-2 pneumonia, influenza pneumonia, or no viral infection at ICU admission. VA-LRTI, including ventilator-associated tracheobronchitis (VAT) and ventilator-associated pneumonia (VAP), were diagnosed using clinical, radiological and quantitative microbiological criteria. All VA-LRTI were prospectively identified, and chest-X rays were analyzed by at least two physicians. Cumulative incidence of first episodes of VA-LRTI was estimated using the Kalbfleisch and Prentice method, and compared using Fine-and Gray models. Results 1576 patients were included (568 in SARS-CoV-2, 482 in influenza, and 526 in no viral infection groups). VA-LRTI incidence was significantly higher in SARS-CoV-2 patients (287, 50.5%), as compared to influenza patients (146, 30.3%, adjusted sub hazard ratio (sHR) 1.60 (95% confidence interval (CI) 1.26 to 2.04)) or patients with no viral infection (133, 25.3%, adjusted sHR 1.7 (95% CI 1.2 to 2.39)). Gram-negative bacilli were responsible for a large proportion (82% to 89.7%) of VA-LRTI, mainly Pseudomonas aeruginosa , Enterobacter spp., and Klebsiella spp. Conclusions The incidence of VA-LRTI is significantly higher in patients with SARS-CoV-2 infection, as compared to patients with influenza pneumonia, or no viral infection after statistical adjustment, but residual confounding may still play a role in the effect estimates.

In adults 65 to 79 years of age, there appeared to be fewer hospitalizations for influenza or pneumonia with high-dose influenza vaccine than with the standard dose, with a similar incidence of serious adverse events.

BackgroundAdalimumab has been used in patients with moderately to severely active rheumatoid arthritis (RA) for over 10 years and has a well-established safety profile across multiple indications.ObjectiveTo update adverse events (AEs) of special interest from global adalimumab clinical trials in patients with RA.MethodsThis analysis includes 15 132 patients exposed to adalimumab in global RA clinical trials. AEs of interest included overall infections, laboratory abnormalities and AEs associated with influenza vaccination. Pregnancy outcome data were collected from the Adalimumab Pregnancy Registry.ResultsSerious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient-years, respectively. Two patients experienced hepatitis B reactivation. No significant laboratory abnormalities were reported with adalimumab-plus-methotrexate compared with placebo-plus-methotrexate. Influenza-related AEs occurred in 5% of vaccinated patients compared with 14% of patients not vaccinated during the study. Relative risk of major birth defects and spontaneous abortions in adalimumab-exposed women were similar between that of unexposed women with RA and healthy women.ConclusionsThis analysis confirms and expands the known safety profile of adalimumab and reports no additional safety risk of laboratory abnormalities, hepatitis B reactivation and pregnancy outcomes, including spontaneous abortions and birth defects. The benefits of influenza vaccination are reinforced.Trial registration numbersNCT00195663, NCT00195702, NCT00448383, NCT00049751, NCT00234845, NCT00650390, NCT00235859, NCT00647920, NCT00649545, NCT00647491, NCT00649922, NCT00538902, NCT00420927, NCT00870467, NCT00650156, NCT00647270, NCT01185288, NCT01185301.

Influenza A viruses are believed to spread between humans through contact, large respiratory droplets and small particle droplet nuclei (aerosols), but the relative importance of each of these modes of transmission is unclear. Volunteer studies suggest that infections via aerosol transmission may have a higher risk of febrile illness. Here we apply a mathematical model to data from randomized controlled trials of hand hygiene and surgical face masks in Hong Kong and Bangkok households. In these particular environments, inferences on the relative importance of modes of transmission are facilitated by information on the timing of secondary infections and apparent differences in clinical presentation of secondary infections resulting from aerosol transmission. We find that aerosol transmission accounts for approximately half of all transmission events. This implies that measures to reduce transmission by contact or large droplets may not be sufficient to control influenza A virus transmission in households. Influenza A viruses spread through contact, large and small respiratory droplets (aerosols), but the relative importance of these modes of transmission is unclear. Cowling et al . model data from community trials of face masks and hand hygiene and find that aerosol transmission accounts for half of influenza occurrences.

In a study over two influenza seasons, a high-dose recombinant influenza vaccine was 15% more effective than a standard-dose vaccine in preventing PCR-confirmed influenza in adults between 50 and 64 years of age.

In this randomized trial conducted over the 2019–2024 influenza seasons, baloxavir resulted in a significantly lower incidence of transmission of influenza virus from patients to household contacts than placebo.

Influenza infection causes significant morbidity in pregnant woman and neonates. In this randomized study of 340 pregnant women in Bangladesh, influenza vaccination during pregnancy was found to decrease laboratory-proven influenza infection in neonates by 63% and febrile respiratory illness in the mothers by more than a third. In pregnant women in Bangladesh, influenza vaccination during pregnancy was found to decrease laboratory-proven influenza infection in neonates by 63% and febrile respiratory illness in the mothers by more than a third. Infection with influenza virus is associated with serious illness and hospitalization among pregnant women 1 – 3 and young infants, including neonates. 4 – 6 Maternal influenza infection has been associated with an increased risk of maternal hospitalization, fetal malformation, and other illnesses. 7 , 8 Influenza infection in young infants often prompts hospitalization and can predispose the infants to bacterial pneumonia or otitis media. 9 , 10 Studies from North America 11 and Hong Kong 12 have shown high rates of hospitalization among infants with influenza, especially those under 6 months of age. 13 The rate of hospitalization for such infants is higher than that for other high-risk groups. A . . .

A novel intranasal influenza vaccine named Ganwu® was approved in 2020 for children aged 3–17 years in China. This study aimed to conduct a phase IV clinical trial to assess the effectiveness and safety of this vaccine. We conducted a multicenter, randomized, double-blind, placebo-controlled phase IV clinical trial to evaluate the effectiveness and safety of Ganwu® vaccine in children aged 3–17 years in China during 2023 to 2024 influenza season. The influenza-like illnesses (ILIs) were monitored in the vaccine and placebo groups during a follow-up period of seven months, and nasopharyngeal specimens from ILI cases were collected for laboratory confirmation of influenza virus. Primary endpoints included vaccine effectiveness against laboratory-confirmed influenza and ILI, with comprehensive safety monitoring throughout the study period. The trial enrolled 6000 participants, randomly allocated in a 1:1 ratio to receive either Ganwu® or placebo. The vaccine's effectiveness in preventing laboratory-confirmed influenza was 46.8 % (95 % confidence interval [CI] 25.8 %–61.9 %), with specific effectiveness rates of 30.4 % against A/H1N1, 55.1 % against A/H3N2, and 84.6 % against B/Victoria. Laboratory-confirmed influenza was significantly less frequent in the vaccine group (hazard ratio 0.53, 95 % CI 0.38–0.74). Effectiveness of Ganwu® vaccine against ILI was 15.2 % (95 % CI -2.3 %–29.7 %). Safety assessments demonstrated comparable incidence of solicited adverse events (AE) between groups, with the incidence of grade three or higher AEs below 1 %. Among 12 reported serious AEs, none were attributed to vaccination. Ganwu® vaccine provided moderate protection against laboratory-confirmed influenza among children with good safety profile.