Hib CRM197 vaccine conjugate(Pfizer)(Hib CRM197 vaccine conjugate(Pfizer))

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

HibTITER

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

感染

在研适应症-

非在研适应症

嗜血杆菌感染

原研机构

Pfizer Inc.

在研机构-

非在研机构

Mitsubishi Tanabe Pharma Corp.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Hib CRM197 vaccine conjugate(Pfizer) 相关的临床试验

NCT02140047 / Completed临床2期

Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)

The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.

开始日期2014-04-01

申办/合作机构

Mitsubishi Tanabe Pharma Corp.

NCT01732198 / Unknown status临床2期

A Phase 2, Multicenter, Randomized, Double-Blind, Immunogenicity, Reactogenicity, and Safety Study of NU300 Booster Dose Compared to ActHIB®, Both Co-administered With Prevnar 13® at 12-15 Months of Age, in Healthy Toddlers Who Have Received a Primary Series of a Licensed Hib Vaccine and Prevnar 13®

Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® over a 28 day period following the injection compared to a single booster of ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.
Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection.

开始日期2013-03-01

申办/合作机构

Nuron Biotech, Inc.

100 项与 Hib CRM197 vaccine conjugate(Pfizer) 相关的临床结果

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100 项与 Hib CRM197 vaccine conjugate(Pfizer) 相关的转化医学

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100 项与 Hib CRM197 vaccine conjugate(Pfizer) 相关的专利（医药）

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21

项与 Hib CRM197 vaccine conjugate(Pfizer) 相关的文献（医药）

2018-05-01·International Journal of Hygiene and Environmental Health2区 · 医学

The risk of neurodevelopmental disorders following Thimerosal-containing Hib vaccine in comparison to Thimerosal-free Hib vaccine administered from 1995 to 1999 in the United States

2区 · 医学

Article

作者: Geier, David A ; Kern, Janet K ; Geier, Mark R ; Homme, Kristin G

Investigators postulated that early-life exposure to organic mercury (Hg) significantly increases the risk of childhood neurodevelopmental disorders (NDs). The Vaccine Adverse Event Reporting System database was utilized to conduct a hypothesis testing case-control study by evaluating 3486 total adverse event reports reported following Haemophilus influenza type b (Hib) vaccination. Exposed subjects received a Thimerosal-containing formulation (HIBTITER™, Wyeth-Lederle), while unexposed subjects received a Thimerosal-free formulation (PEDVAXHIB™, Merck). Subjects were included if they received either of these two Hib vaccine formulations between 1995 and 1999. Cases were defined as adverse event reports with a reported outcome of autism, developmental delay, psychomotor delay, or NDs in general. Cases with reported outcomes of febrile convulsions, pyrexia, or injection site pain, all of which have no biologically plausible relation to Hg exposure, were also examined. Controls were defined as adverse event reports without any mention of the specific case outcome examined. Cases of reported autism (odds ratio (OR) = 2.75, p < 0.02), developmental delay (OR = 5.39, p < 0.01), psychomotor disorder (OR = 2.38, p < 0.03), and neurodevelopmental disorder in general (OR = 2.70, p < 0.001) were each significantly more likely than their respective controls to receive Thimerosal-containing Hib vaccine than Thimerosal-free Hib vaccine. Significant effects for neurodevelopmental disorder in general were observed for males (OR = 2.52, p < 0.005), but not females when separated by gender. For the outcomes that had no biologically plausible relation to Hg exposure, the cases were no more likely than their respective controls to receive Thimerosal-containing Hib vaccine than Thimerosal-free Hib vaccine. This study provides suggestive evidence of an association between Thimerosal and neurodevelopmental outcomes and provides support for carrying out additional well-designed studies examining the association between Thimerosal-containing vaccines and a wide range of neurodevelopmental outcomes.

2005-12-01·Vaccine3区 · 医学

Immunogenicity and effectiveness of Haemophilus influenzae type b conjugate vaccine in HIV infected and uninfected African children

3区 · 医学

Article

作者: Locadiah Kuwanda ; Rosalia Mothupi ; Keith P. Klugman ; Shabir A. Madhi ; Leena Saarinen ; Helena Käyhty ; Clare Cutland

The quantitative (anti-Hib capsular polysaccharide antibody concentrations; anti-HibPS) and qualitative (bactericidal activity and avidity) aspects in immune responses to Haemophilus influenzae type b polyribosyl ribitol phospshate-CRM(197) conjugate vaccine (HibCV; HibTiter) were evaluated in 66 HIV infected children not receiving anti-retroviral therapy and 127 HIV uninfected children. Surveillance was conducted for invasive Hib disease in a cohort of 39,865 (approximately 6.4% of whom were HIV infected) children from March 1998 to June 2004. HIV infected children had lower anti-HibPS geometric mean antibody concentrations 1 month post-immunisation than HIV uninfected children (P<0.00001) and were less likely to have anti-HibPS antibody concentrations of >or=1.0 microg/ml (RR 0.54; 95% CI 0.43-0.69). A lower proportion of HIV infected children than HIV uninfected children (RR 0.78; 95% CI 0.66-0.93) had measurable anti-Hib serum bactericidal activity (SBA) and the HibPS antibody concentration required for 50% killing of Hib bacteria was greater among HIV infected than HIV uninfected children (P=0.001). The estimated risk of HibCV failure was 35.1-fold greater (95% CI 14.6-84.6) amongst HIV infected than HIV uninfected children.

2005-02-01·Vaccine3区 · 医学

Double-blind study comparing the immunogenicity of a licensed DTwPHib-CRM197 conjugate vaccine (Quattvaxem™) with three investigational, liquid formulations using lower doses of Hib-CRM197 conjugate

3区 · 医学

Article

作者: Pantaleo Nacci ; Alessandra Veronese ; Eda Tamm ; Sirli Meriste ; Simonetta Viviani ; Mario Contorni

We performed a double-blind clinical study to evaluate the safety and immunogenicity of four formulations of a DTwPHib full liquid vaccine, three of which contained fractional doses of the 10 microg-dose of CRM197-Hib conjugate vaccine. A total of 261 infants were enrolled and randomised to receive at 3, 4 and 5 months of age, in a double-blind fashion, one of the four DTwPHib vaccine formulations containing 10, 5, 2.5 or 1.25 microg of CRM197-Hib conjugate. Post-immunization reactions were similar in the four vaccine groups, they were mild, transient and resolved without sequelae. The seroconversion rates to anti-PRP titres > or = 0.15 microg/mL were 100%, 98%, 97% and 98% in the groups 10, 5, 2.5 and 1.25 microg, respectively. The seroconversion rates to anti-PRP titres > or =1 microg/mL were 95%, 97%, 88% and 90%, again respectively. Anti-PRP GMTs were 18, 17, 7.82 and 6.94 microg/mL, respectively. All subjects were protected against tetanus and diphtheria, and >80% seroconverted to pertussis. High, and similar, levels of anti-PRP GMTs were elicited by the formulations with 10 and 5 microg of CRM197-Hib conjugate. Although the formulations with 2.5 and 1.25 microg of CRM197-Hib elicited lower levels of anti-PRP GMTs, they were immunogenic and are possible candidates for further development.

100 项与 Hib CRM197 vaccine conjugate(Pfizer) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
嗜血杆菌感染	临床2期	日本	Mitsubishi Tanabe Pharma Corp.	2014-04-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02140047 (CTgov)	临床2期	嗜血杆菌感染	154	Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-Low)	蓋蓋鏇觸繭蓋鹽憲齋膚(淵鹹衊鹹齋鹽鏇構壓淵) = 壓鑰憲壓壓積鑰蓋鏇鏇鑰簾蓋築廠築鑰鬱範窪 (積積蓋鏇範餘顧願繭繭, 襯艱顧艱網鑰廠簾鹹壓 ~ 鏇遞襯簾餘艱夢衊繭窪) 更多	-	2024-09-19
				Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate+DPT-IPV (MT-2301-High)	蓋蓋鏇觸繭蓋鹽憲齋膚(淵鹹衊鹹齋鹽鏇構壓淵) = 壓壓鹹廠醖憲壓鹹願糧鑰簾蓋築廠築鑰鬱範窪 (積積蓋鏇範餘顧願繭繭, 觸鹽獵鏇餘網簾窪醖齋 ~ 選膚範選淵願繭鬱鑰鹽) 更多