吸附白喉类毒素(财団法人坂大微生物病研究会)(Adsorbed Diphtheria Toxoid(Research Fdn for Microbial Diseases of Osaka University))

概要

基本信息

药物类型

联合疫苗、预防性疫苗、类毒素疫苗

别名-

靶点-

作用机制-

治疗领域

感染

在研适应症

白喉

非在研适应症-

原研机构

Research Fdn for Microbial Diseases of Osaka University

在研机构

Mitsubishi Tanabe Pharma Corp.Research Fdn for Microbial Diseases of Osaka University

非在研机构-

最高研发阶段批准上市

首次获批日期

日本 (2006-08-04),

白喉

最高研发阶段(中国)-

特殊审评-

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关联

2

项与吸附白喉类毒素(财団法人坂大微生物病研究会) 相关的临床试验

EUCTR2015-005844-32-Outside-EU/EEA / Unknown statusN/A

One-, Three-, Five- and Ten-Year Data on the Long-Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adolescents 11–14 Years of Age

开始日期-

申办/合作机构

Sanofi Pasteur, Inc.

EUCTR2015-005843-15-Outside-EU/EEA / Unknown statusN/A

One-, Three-, Five-, Eight- and Ten-Year Data on the Long- Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adults and Adolescents

开始日期-

申办/合作机构

Sanofi Pasteur, Inc.

100 项与吸附白喉类毒素(财団法人坂大微生物病研究会) 相关的临床结果

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100 项与吸附白喉类毒素(财団法人坂大微生物病研究会) 相关的转化医学

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100 项与吸附白喉类毒素(财団法人坂大微生物病研究会) 相关的专利（医药）

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770

项与吸附白喉类毒素(财団法人坂大微生物病研究会) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Antenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization and risk of serogroup 19 IPD in children: An indirect cohort study

Article

作者: Brousseau, Nicholas ; Thibault, Melina ; Deceuninck, Geneviève ; Quach, Caroline

The tetanus-diphtheria-acellular pertussis (Tdap) vaccine has been indicated for pregnant women in Quebec, Canada since 2018. Recent literature suggests maternal Tdap interferes with the pneumococcal vaccine response in children exposed in utero because of maternally transferred anti-diphtheria antibodies, a phenomenon known as blunting. Using an indirect cohort study, we investigated whether maternal Tdap vaccination could alter the protection of PCV vaccines against serotype 19A/F IPD (conjugated to diphtheria toxoid in PCV10). Thirty-seven immunized IPD cases (serotype 19A/F) and 90 immunized IPD controls (non-vaccine serotypes) were analyzed using multivariate logistic regression. Our analyses did not identify antenatal Tdap exposure as a risk factor for IPD in vaccinated children, with and odds ratio close to the null (odds ratio = 0.82, 95%CI = 0.32-2.07). As this study is the first to assess the impact of maternal immunization on pneumococcal disease risk, future investigations involving a larger number of cases should be conducted to confirm or infirm our findings.

2024-05-01·American Journal of Perinatology

Routine Maternal Vaccine Uptake during the COVID-19 Pandemic

Article

作者: Miao, Di ; Ratan, Bani M. ; Cotter, Savannah ; Taylor, Lauren ; Grace, Rebecca

Objective This study examines the impact of the coronavirus disease 2019 (COVID-19) pandemic on influenza and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine uptake in a pregnant, low-income population. Study Design This retrospective cohort study included women initiating prenatal care before (May–November 2019) or during the COVID-19 pandemic (May–November 2020) at two large Medicaid clinics. All patients entered prenatal care before 20 weeks and delivered full-term. Medical records were reviewed for vaccine uptake and demographic data. Multivariate logistic regression analysis was used to compare vaccination rates prior to and during the COVID-19 pandemic. Additional analysis was performed to identify association of demographic factors with vaccine uptake. IRB approval was obtained for this study. Results A total of 939 patients met inclusion criteria, with 462 initiating care prior to and 477 initiating care during the COVID-19 pandemic. Influenza vaccination uptake was 78% (362/462) in the prepandemic group, significantly decreasing to 61% (291/477) in the pandemic group (p <0.01, odds ratio [OR] = 0.38, confidence interval [CI]: 0.26–0.53). Tdap vaccination uptake was 85% (392/462) in the prepandemic group, significantly decreasing to 76% (361/477) in the pandemic group (p <0.01, OR = 0.56, CI: 0.40–0.79). The decrease in influenza vaccine uptake was most significant in non-Hispanic Black patients, decreasing from 64% (73/114) in the prepandemic group to 35% (35/101) in the pandemic group (p <0.01, OR = 0.30, CI: 0.17–0.52), while there was no significant difference in age or parity in relation to vaccination status. Conclusion Routine vaccination uptake significantly decreased during the COVID-19 pandemic in a low-income population of pregnant women, with decrease more pronounced on influenza vaccine than on Tdap vaccine uptake, especially in non-Hispanic Black patients. Key Points

2023-12-31·Expert Review of Vaccines

Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India

Article

作者: Parekh, Sameer ; Mahantashetti, N ; Somshekhar, A ; Shewale, Sunil ; Rao, Harish ; Kawade, Anand ; Desai, Shivani ; Ginsburg, Amy Sarah ; Ghosh, Apurba ; James, Saji ; Munshi, Renuka ; Shaligram, Umesh ; Ravi, Mandyam ; Gautam, Manish ; Balsubramaniam, Sundaram ; Pujari, Pramod ; Varughese, P ; Oswal, Jitendra ; Rao, Venkateshwar ; Gairola, Sunil ; Sharma, Hitt J

BACKGROUNDThis study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap).RESEARCH DESIGN AND METHODSIn this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment.RESULTSNo significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination.CONCLUSIONSBooster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.

100 项与吸附白喉类毒素(财団法人坂大微生物病研究会) 相关的药物交易

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