GRC28 Study Team. Safety and immunogenicity of trivalent inactivated influenza vaccine in infants: a randomized double-blind placebo-controlled study
ABSTRACT Infants less than 6 months of age are at high risk for influenza disease and influenza-related complications, but no vaccine is licensed for this population.
A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6 to 12 weeks of age. Subjects received 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone, sanofi pasteur; N = 915) or placebo (N = 460) 1 month apart in combination with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following vaccination, and unsolicited adverse events for 28 days. Hemagglutination-inhibition antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose.
No significant differences were seen between TIV and placebo groups for any safety outcome. Fever > or =38 degrees C within 3 days of vaccination was seen in 11.2% versus 11.7% of TIV versus placebo recipients. Serious adverse events within 28 days were reported in 1.9% of TIV and 1.5% of placebo recipients. Antibody responses to childhood vaccines were similar in both groups. Increased influenza-specific antibody responses in TIV recipients compared with placebo recipients were seen against all 3 strains in TIV recipients (P < 0.001), with better responses to influenza A strains noted. Reciprocal geometrical mean titer to H1N1, H3N2, and B were 33, 95, and 11 in TIV recipients versus 7, 9, and 5 for placebo recipients. Over 90% of TIV recipients had antibody > or =1:40 for at least 1 vaccine strain and 49.6% for 2 strains, versus 16.4% and 0.9% in placebo-recipients.
TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.
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ABSTRACT: This paper presents a coded block adaptive neural network system using a radical-partitioned structure for large-volume Chinese characters recognition. Using the coded block adaptive neural network system with a radical-partitioned structure, 1,000 frequently-used Chinese characters have been successfully trained in 139.2 hours using an 18 MIPs computer. According to the simulation results, the coded block system with a radical-partitioned structure provides an acceptable learning time, a good recognition rate, and an excellent expansion capability for large-volume Chinese characters recognition.Neural Networks 09/1992; DOI:10.1016/S0893-6080(05)80143-1 · 2.08 Impact Factor
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ABSTRACT: Rational drug design based on molecular targets is starting to revolutionize cancer care. To maximize its potential for patients, a concomitant leveraging of molecular knowledge for selection of patients to future and current therapeutic options is paramount. The terms "individualized", "personalized", or "precision therapy" are currently used to describe these efforts. Here, we summarize current knowledge for selection of systemic targeted and cytotoxic therapy for patients with non-small-cell lung cancer. Based on this knowledge, we present a potential decision algorithm to best select patients for currently available therapies, which include the treatment options single-agent erlotinib or gefitinib, the ALK inhibitor crizotinib, double agent gemcitabine and platinum, double agent platinum and pemetrexed, and as a default option a taxane combined with a non-platinum drug, for instance a vinca alkaloid. The addition of bevacizumab to double-agent chemotherapy is also discussed. Currently available data on predictive biomarkers are largely based on subgroup or companion biomarker analyses of patient cohorts or clinical trials. Current and emerging markers must be incorporated prospectively into the design of clinical trials that test novel and established agents to better understand their clinical utility and to refine selection parameters and marker interactions. Future development will lead to increasing complexity in clinical decision making with substantial anticipated benefits to patients including increased therapeutic efficacy, reduced toxicity, and better quality of life.Drug resistance updates: reviews and commentaries in antimicrobial and anticancer chemotherapy 11/2010; 13(6):196-204. DOI:10.1016/j.drup.2010.10.001 · 8.82 Impact Factor
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