• Title/Summary/Keyword: geometric safety

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The Safety and Immunogenicity of a Trivalent, Live, Attenuated MMR Vaccine, PriorixTM (MMR(Measles-Mumps-Rubella) 약독화 생백신인 프리오릭스주를 접종한 후 안전성과 유효성의 평가에 관한 연구)

  • Ahn, Seung-In;Chung, Min-Kook;Yoo, Jung-Suk;Chung, Hye-Jeon;Hur, Jae-Kyun;Shin, Young-Kyu;Chang, Jin-Keun;Cha, Sung-Ho
    • Clinical and Experimental Pediatrics
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    • v.48 no.9
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    • pp.960-968
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    • 2005
  • Purpose : This multi-center, open-label, clinical study was designed to evaluate the safety and immunogenicity of a trivalent, live, attenuated measles-mumps-rubella(MMR) vaccine, $Priorix^{TM}$ in Korean children. Methods : From July 2002 to February 2003, a total of 252 children, aged 12-15 months or 4-6 years, received $Priorix^{TM}$ at four centers : Han-il General Hospital, Kyunghee University Hospital, St. Paul's Hospital at the Catholic Medical College in Seoul, and Korea University Hospital in Ansan, Korea. Only subjects who fully met protocol requirements were included in the final analysis. The occurrence of local and systemic adverse events after vaccination was evaluated from diary cards and physical examination for 42 days after vaccination. Serum antibody levels were measured prior to and 42 days post-vaccination using IgG ELISA assays at GlaxoSmithKline Biologicals (GSK) in Belgium. Results : Of the 252 enrolled subjects, a total of 199 were included in the safety analysis, including 103 from the 12-15 month age group and 96 from the 4-6 year age group. The occurrence of local reactions related to the study drug was 10.1 percent, and the occurrence of systemic reactions was 6.5 percent. There were no episodes of aseptic meningitis or febrile convulsions, nor any other serious adverse reaction. In immunogenicity analysis, the seroconversion rate of previously seronegative subjects was 99 percent for measles, 93 percent for mumps and 100 percent for rubella. Both age groups showed similar seroconversion rates. The geometric mean titers achieved, 42 days pos-tvaccination, were : For measles, in the age group 12-15 months, 3,838.6 mIU/mL [3,304.47, 4,458.91]; in the age group 4-6 years, 1,886.2 mIU/mL [825.83, 4,308.26]. For mumps, in the age group 12-15 months, 956.3 U/mL [821.81, 1,112.71]; in the age group 4-6 years, 2,473.8 U/mL [1,518.94, 4,028.92]. For rubella, in the age group 12-15 months, 94.5 IU/mL [79.56, 112.28]; in the age group 4-6 years, 168.9 IU/mL [108.96, 261.90]. Conclusion : When Korean children in the age groups of 12-15 months or 4-6 years were vaccinated with GlaxoSmithKline Biologicals' live attenuated MMR vaccine ($Priorix^{TM}$), adverse events were limited to those generally expected with any live vaccine. $Priorix^{TM}$ demonstrated excellent immunogenicity in this population.

Immunogenicity and Safety of a Combined Hepatitis B and Haemophilus influenzae Type b Conjugate(PRP-OMP) Vaccine(ComvaxTM; Merck & Co.) in Korean Infants (한국 영아에서 B형 간염과 PRP-OMP의 혼합백신(ComvaxTM; MSD사)의 면역원성 및 안전성)

  • Chung, Eun Hee;Ma, Sang Hyuck;Hong, Young Jin;Kim, Kyung Hyo;Kim, Jong-Hyun;Lee, Jin A;Lee, Hoan Jong
    • Pediatric Infection and Vaccine
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    • v.13 no.2
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    • pp.163-173
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    • 2006
  • Purpose : To reduce the number of injections necessary to vaccinate young infants, various combined vaccines have been developed. The $Comvax^{TM}$ manufactured by Merck & Co. is a combination of Hepatitis B and PRP-OMP conjugate Haemophilus influenzae Type b vaccine. The purpose of this study is to evaluate the immunogenicity and safety of $Comvax^{TM}$ in Korean infants. Methods : The infants who were vaccinated at 0 months of age with Hepatitis B vaccine, were recruited for this study after parental informed consent was obtained. The subjects were vaccinated with $Comvax^{TM}$ at 2 and 4 months of age. At each visit, infants were also immunized with DTaP, inactivated poliovirus vaccine, and pneumococcal vaccine when indicated. The serum anti-PRP and anti-HBs were measured at 2 months after the 1st dose(4 months age), and the 2nd dose(6 months age) by the ELISA and chemiluminescent microparticle immunoassay method, respectively. The local and systemic adverse reactions of vaccination were monitored for 3 consecutive days after each immunization. Results : Among sixty-five healthy infants(35 male infants) enrolled in this study; fifty eight(32 male infants) completed the scheduled immunizations. The geometric mean titers (GMTs) of anti-PRP at 2 months after the 1st dose and the 2nd dose were 1.96 ${\mu}g/mL$ (95% CI; 1.38~2.78) and 10.02 ${\mu}g/mL$ (95% CI; 7.04~14.26), respectively. Anti-PRP ${\geq}1.0$ ${\mu}g/mL$, was obtained in 63.2%(95% CI; 53.75~72.65) after 1 dose, and 96.6%(95% CI; 93.05~100) after 2 doses. The GMTs of anti-HBs were 38.32 mIU/mL(95% CI; 22.42~65.51), and 101.17 mIU/mL(95% CI; 65.94~155.25) at 2 month after the 1st dose and 2nd dose of $Comvax^{TM}$, respectively. Anti-HBs ${\geq}10$ mIU/mL was observed in 73.7%(95% CI; 65.07~82.33) after 1 dose and 94.8%(95% CI; 90.45~99.15) after 2 doses. Most of the adverse reactions after vaccination were mild. Irritability, the most common systemic reaction, was observed in 24.8%, followed by drowsiness(19.2%), poor feeding(19.2%) and fever(7.2%). Among the local reactions tenderness was observed in 25.6%, redness(${\geq}5$ mm) in 19.2% and swelling(${\geq}5$ mm) in 4.8%. Conclusion : The $Comvax^{TM}$ vaccine was highly immunogenic for PRP and safe in Korean infants. Although the hepatitis B vaccine component was administered at 0, 2, 4 months, this study showed good immunogenicity against HBsAg.

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Electrode Characteristics of K+ Ion-Selective PVC Membrane Electrodes with AC Impedance Spectrum (AC 임피던스 분석법을 이용한 K+ 이온선택성 PVC막 전극 특성)

  • Kim, Yong-Ryul;An, Hyung-Hwan;Kang, An-Soo
    • Applied Chemistry for Engineering
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    • v.9 no.6
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    • pp.870-877
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    • 1998
  • With impedance spectrum measurements, impedance was studied in the interface between sample solutions for $K^+-ion$ selective PVC membrane electrode containing neutral carriers [dibenzo-18-crown-6 (D18Cr6) and valinomycine (Val)]. Response characteristics of electrode were examined by measuring AC impedance spectra that were resulted from the chemical structure and the content of carrier, variation of plasticizer, membrane thickness, doping of base electrolytes, and concentration variation of sample solution. Transport characteristics of PVC membrane electrode were also studied. It was found that the equivalent circuit for the membrane in $K^+$ solution could be expressed by a series combination of solution resistance and a parallel circuit consisting of the bulk resistance and geometric capacitance of the membrane system. But the charge transfer resistance and Warburg resistance were overlapped a little in the low concentration and low frequency ranges. The carrier, D18Cr6 was best for electrode and impedance characteristics, and ideal electrode characteristics were appeared especially in case of doping of the base electrolyte[potassium tetraphenylborate(TPB)]. The optimum carrier content was about 3.23 wt% in case of D18Cr6 and Val. DBP was best as a plasticizer. As membrane thickness decreased the impedance characteristics was improved, but electrode characteristics were lowered for membrane thickness below the optimum. In the case of D18Cr6, the selectivity coefficients by the mixed solution method for the $K^+$ ion were the order of $NH_4{^+}>Ca^{2+}>Mg^{2+}>Na^+$.

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Airborne Concentrations of Welding Fume and Metals of Workers Exposed to Welding Fume (용접사업장 근로자의 흄 및 금속 노출농도에 대한 평가와 혈중 금속 농도)

  • Choi, Ho-Chun;Kim, Kangyoon;An, Sun-Hee;Park, Wha-Me;Kim, So-Jin;Lee, Young-Ja;Chang, Kyou-Chull
    • Journal of Korean Society of Occupational and Environmental Hygiene
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    • v.9 no.1
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    • pp.56-72
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    • 1999
  • Airborne concentrations of welding fumes in which 13 different metals such as Al, Cd, Cr, Cu, Fe, Mn, Mo, Ni, Pb, Si, Sn, Ti, and Zn were analyzed were measured at 18 factories including automobile assembly and manufactures, steel heavy industries and shipyards. Air samples were collected by personal sampler at each worker's worksite(n=339). Blood levels of Cd, Cu, Fe, Mn, Pb and Zn were also measured from samples taken from 447 welders by atomic absorption spectrometry and compared with control values obtained from 127 non-exposed workers. The results were as follows ; 1. Among various welding types, $CO_2$ welding 70.2 % were widely used, shielded metal arc welding(SMAW) 22.1 % came next, and rest of them were metal inert gas(MIG) welding, submerged arc welding(SAW), spot welding(SPOT) and tungsten inert gas(TIG) welding. 2. Welding fume concentration was $0.92mg/m^3$($0.02{\sim}15.33mg/m^3$) at automobile assembly and manufactures, $4.10mg/m^3$($0.02{\sim}70.75mg/m^3$) at steel heavy industries and $5.59mg/m^3$($0.30{\sim}91.16mg/m^3$) at shipyards, respectively, showing significant difference among industry types. Workers exposed to high concentration of welding fumes above Korean Permissible Exposure Limit(KPEL) amounted to 7.9 % and 12.5 %, in $CO_2$ welding and in SMAW at automobile assembly and manufactures and 62.7 % in $CO_2$ welding, and 12.5 % in SMAW at shipyards, and 66.2 % in $CO_2$ welding and 70.6 % in SMAW at steel heavy industries. 3. Geometric mean of airborne concentration of each metal released from welding fumes was below one 10th of KPEL in all welding types. Percentage of workers, however, exposed to airborne concentration of metals above KPEL amounted to 16.8 % in Mn and 7.6 % in Fe in $CO_2$ welding; 37.5 % in Cu in SAW, 30 % in Cu in TIG; and 25 % in Pb in SPOT welding. As a whole, 76 Workers(22.4%) were exposed to high concentration of any of the metals above KPEL. 4. There were differences in airborne concentration of metals such as Al, Cd, Cr, Cu. Fe. Mn, Mo, Ni, Pb, Si, Sn, Ti and Zn by industry types. These concentrations were higher in shipyards and steel heavy industries than in automobile assembly and manufactures. Workers exposed to higher concentration of Pb above KPEI amounted to 7.4 % of workers(7/94) in automobile assembly and manufactures. In shipyards, 19.2 % of workers(19/99) were over-exposed to Mn and 7.1 % (7/99) to Fe above KPEL. In steel heavy industries, 14.4 %(21/146), 7.5 %(11/146) and 13 %(19/146) were over-exposed to Mn, Fe and Cu, respectively. As a whole, 76 out of 339 workers(22.4%) were exposed to any of the metals above KPEL. 5. Blood levels of Cd, Cu, Fe, Mn, Pb, and Zn in welders were $0.11{\mu}g/100m{\ell}$, $0.84{\mu}g/m{\ell}$, $424.4{\mu}g/m{\ell}$, $1.26{\mu}g/100m{\ell}$, $5.01{\mu}g/100m{\ell}$ and $5.68{\mu}g/m{\ell}$, respectively, in contrast to $0.09{\mu}g/100m{\ell}$, $0.70{\mu}g/m{\ell}$, $477.2{\mu}g/m{\ell}$, $0.73{\mu}g/100m{\ell}$, $3.14{\mu}g/100m{\ell}$ and $6.15{\mu}g/m{\ell}$ in non-exposed control groups, showing significantly higher values in welders but Fe and Zn.

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Developing a Traffic Accident Prediction Model for Freeways (고속도로 본선에서의 교통사고 예측모형 개발)

  • Mun, Sung-Ra;Lee, Young-Ihn;Lee, Soo-Beom
    • Journal of Korean Society of Transportation
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    • v.30 no.2
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    • pp.101-116
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    • 2012
  • Accident prediction models have been utilized to predict accident possibilities in existing or projected freeways and to evaluate programs or policies for improving safety. In this study, a traffic accident prediction model for freeways was developed for the above purposes. When selecting variables for the model, the highest priority was on the ease of both collecting data and applying them into the model. The dependent variable was set as the number of total accidents and the number of accidents including casualties in the unit of IC(or JCT). As a result, two models were developed; the overall accident model and the casualty-related accident model. The error structure adjusted to each model was the negative binomial distribution and the Poisson distribution, respectively. Among the two models, a more appropriate model was selected by statistical estimation. Major nine national freeways were selected and five-year dada of 2003~2007 were utilized. Explanatory variables should take on either a predictable value such as traffic volumes or a fixed value with respect to geometric conditions. As a result of the Maximum Likelihood estimation, significant variables of the overall accident model were found to be the link length between ICs(or JCTs), the daily volumes(AADT), and the ratio of bus volume to the number of curved segments between ICs(or JCTs). For the casualty-related accident model, the link length between ICs(or JCTs), the daily volumes(AADT), and the ratio of bus volumes had a significant impact on the accident. The likelihood ratio test was conducted to verify the spatial and temporal transferability for estimated parameters of each model. It was found that the overall accident model could be transferred only to the road with four or more than six lanes. On the other hand, the casualty-related accident model was transferrable to every road and every time period. In conclusion, the model developed in this study was able to be extended to various applications to establish future plans and evaluate policies.