b型流感嗜血杆菌结合疫苗(Sanofi)(Haemophilus b conjugate vaccine(Sanofi)) - 在研适应症：嗜血杆菌感染_专利_临床

概要

基本信息

药物类型

预防性疫苗、类毒素疫苗、结合疫苗

别名

Haemophilus influenzae type b conjugate vaccine、Haemophilus influenzae type b conjugate vaccine (Sanofi)、Haemophilus type b conjugate vaccine

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靶点-

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

嗜血杆菌感染

非在研适应症-

原研机构

Sanofi

在研机构

Sanofi PasteurSanofi KK

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2000-02-04),

嗜血杆菌感染

最高研发阶段(中国)批准上市

特殊审评-

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关联

11

项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的临床试验

NCT03630705 / Completed临床3期

Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

Primary Objective:
To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico.
To describe the vaccine seroprotection (antibody titer >=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation.
Secondary Objective:
To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF).
To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone.
To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF.
To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

开始日期2018-10-17

申办/合作机构

Sanofi Pasteur

NCT03691610 / Completed临床3期

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
* To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
* To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.

开始日期2018-10-04

申办/合作机构

Sanofi Pasteur

NCT01578070 / Completed临床1/2期

A Single-centre Study Evaluating the Safety of ViscoGel® and Its Safety and Efficacy as an Adjuvant in Act-HIB® Vaccine Administered by Intramuscular Injection to Healthy Volunteers in a Single-blind Randomised, Parallel-group Design

The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.

开始日期2012-03-01

申办/合作机构

Viscogel AB

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100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的临床结果

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100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的转化医学

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100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的专利（医药）

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172

项与 b型流感嗜血杆菌结合疫苗(Sanofi) 相关的文献（医药）

2024-04-01·Vaccine

Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants ≥ 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study

Article

作者: Nakano, Takashi ; Tamai, Hoshio ; Matsuda, Keiko ; Hasegawa, Masumi ; Endo, Mai

OBJECTIVE:

This study investigated the immunogenicity and safety of a pentavalent vaccine Gobik (DPT-IPV-Haemophilus influenzae type b [Hib]) in healthy Japanese infants aged ≥ 2 and < 43 months using a concomitant vaccination with ActHIB® (Hib) and Tetrabik (DPT-IPV) as a comparator.

METHODS:

This study was conducted as a phase 3, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Participants received a total of 4 subcutaneous doses (3 primary immunization doses and a booster dose) of either the experimental drug (DPT-IPV-Hib) or the active comparator (Hib + DPT-IPV). The primary endpoints were the anti-PRP antibody prevalence rate with ≥ 1 μg/mL, and the antibody prevalence rates against pertussis, diphtheria toxin, tetanus toxin, and attenuated poliovirus after the primary immunization.

RESULTS:

In 267 randomized participants (133 in the DPT-IPV-Hib group and 134 in the Hib + DPT-IPV group), the antibody prevalence rates after the primary immunization in both groups were 100.0 % and 88.7 % for anti-PRP antibody with ≥ 1 μg/mL, 99.2 % and 98.5 % against diphtheria toxin, and 100.0 % and 99.2 % against tetanus toxin, respectively. The antibody prevalence rates against pertussis and attenuated poliovirus were 100.0 % in both groups. The non-inferiority of the DPT-IPV-Hib group to the Hib + DPT-IPV group was verified for all measured antibodies. In both groups, all the GMTs of antibodies after the primary immunization were higher than those before the first dose, and those after the booster dose were higher than those after the primary immunization. No safety issues were identified.

CONCLUSION:

A single-agent Gobik, the first DPT-IPV-Hib pentavalent vaccine approved in Japan, was confirmed to simultaneously provide primary and booster immunizations against Hib infection, pertussis, diphtheria, tetanus, and poliomyelitis and to have a preventive effect and safety comparable to concomitant vaccination with Hib (ActHIB®) and DPT-IPV quadrivalent vaccine (Tetrabik).

2021-12-01·BMC medicine1区 · 医学

National and provincial impact and cost-effectiveness of Haemophilus influenzae type b conjugate vaccine in China: a modeling analysis

1区 · 医学

ArticleOA

作者: Lai, Xiaozhen ; Yu, Wenzhou ; Qin, Ying ; Zhang, Haijun ; Xu, Tingting ; Jing, Rize ; Fang, Hai ; Yin, Zundong ; Knoll, Maria Deloria ; Garcia, Cristina ; Wahl, Brian

Abstract:

Background:

Globally,Haemophilus influenzaetype b (Hib) vaccine has substantially reduced the burden of Hib invasive disease. However, China remains the only country not to include Hib vaccine into its national immunization program (NIP), although it accounts for 11% of global Hib deaths. We aimed to assess the cost-effectiveness of including Hib vaccine in China’s NIP at the national and provincial levels.

Methods:

Using a decision-tree Markov state transition model, we estimated the cost-effectiveness of Hib vaccine in the NIP compared to thestatus quoof Hib vaccine in the private market for the 2017 birth cohort. Treatment costs and vaccine program costs were calculated from Chinese Center for Disease Control and Prevention (CDC) and national insurance databases. Epidemiological data and other model parameters were obtained from published literature. Cases and deaths averted, quality-adjusted life years (QALYs) gained, and incremental cost-effectiveness ratios (ICER) were predicted by province. Deterministic and probabilistic sensitivity analyses were performed to explore model uncertainty.

Results:

Including Hib vaccine in the NIP was projected to prevent approximately 2700 deaths (93% reduction) and 235,700 cases of Hib disease (92% reduction) for the 2017 birth cohort at the national level. Hib vaccine was cost-effective nationally (US$ 8001 per QALY gained) compared to the GDP per capita and cost-effective in 15 of 31 provinces. One-way and scenario sensitivity analyses indicated results were robust when varying model parameters, and in probabilistic sensitivity analysis, Hib vaccine had a 64% probability of being cost-effective nationally.

Conclusion:

Introducing Hib vaccine in China’s NIP is cost-effective nationally and in many provinces. Less socioeconomically developed provinces with high Hib disease burden and low access to Hib vaccine in the current private market, such as those in the west region, would benefit the most from adding Hib vaccine to the NIP. In the absence of a national policy decision on Hib vaccine, this analysis provides evidence for provincial governments to include Hib vaccine into local immunization programs to substantially reduce disease burden and treatment costs.

2021-11-01·Journal of chromatography. B, Analytical technologies in the biomedical and life sciences3区 · 医学

A reversed phase HPLC-UV method for the simultaneous determination of residual formaldehyde and Triton X-100 in vaccine products

3区 · 医学

Article

作者: Kumar Gambheerrao, Sampreeth ; V N Janardhan Reddy, M ; Rajendar, Burki ; N V Suresh, Ch ; Matur, Ramesh V

Many of the inactivated viral vaccines for human and animal use are manufactured using formaldehyde as an inactivating agent. Apart from formaldehyde, Triton X-100 is also one of the chemicals commonly used in viral vaccine manufacturing. Triton X-100 is typically used to extract the cell-associated viruses and / or components during manufacturing process. The concentration of formaldehyde and Triton X-100 in the final bulks are also reduced during vaccine purification process. Here we report a simple RP-HPLC-UV based method for the quantification of residual Triton X-100 and formaldehyde as process impurities in viral vaccines. This method is also adopted for the residual impurity determination of either formaldehyde or Triton X-100 in other non-viral vaccines, multivalent as well as sub-unit vaccines, such as liquid pentavalent, includes TT, DT, Hepatitis B (rDNA) and Haemophilus type b conjugate vaccine (adsorbed). This method is rapid and can quantify both Triton X-100 and formaldehyde in a single preparation with improved peak asymmetry. This new assay has a linearity range starting from 0.0625 to 1 µg/mL for formaldehyde and 0.625-10 µg/mL for Triton X-100. This method would be very useful for viral vaccine manufacturing and release.

100 项与 b型流感嗜血杆菌结合疫苗(Sanofi) 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

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
嗜血杆菌感染	美国	Sanofi Pasteur	2000-02-04

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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


NCT03691610 (CTgov)	临床3期	脑膜炎球菌感染	950	MenACYW conjugate vaccine (Infants: Group 1)	醖築繭繭壓觸餘範膚鹽(壓觸餘襯製艱製簾醖淵) = 窪顧積艱顧蓋積鏇淵鏇鏇淵餘襯憲獵鏇糧範襯 (製顧憲壓膚糧蓋鑰願選, 蓋衊糧醖淵鹽醖範餘廠 ~ 糧簾願願齋廠構鹹齋醖) 更多	-	2024-06-25
				MENVEO (Infants: Group 2)	醖築繭繭壓觸餘範膚鹽(壓觸餘襯製艱製簾醖淵) = 繭廠鹽繭壓廠鑰繭膚觸鏇淵餘襯憲獵鏇糧範襯 (製顧憲壓膚糧蓋鑰願選, 艱觸觸壓齋膚壓廠襯淵 ~ 範網鹽襯網範選鬱蓋鑰) 更多
NCT03630705 (MET33, CTgov)	临床3期	脑膜炎球菌感染	525	Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Pneumococcal 13-valent Conjugate Vaccine+Rotavirus Vaccine, Live, Pentavalent (Group 1: MenACYW Conjugate Vaccine (Mexico))	窪顧構構獵餘鏇築製艱(顧觸範觸糧糧醖壓製網) = 憲廠艱廠選廠鹹襯鬱遞簾廠齋膚繭獵積範襯構 (壓觸築範選憲鬱夢鹽醖, 積糧衊繭鏇膚選襯鑰衊 ~ 醖蓋製襯淵膚齋遞蓋築) 更多	-	2023-10-19
				Rubella Virus Vaccine Live+W) Tetanus Toxoid Conjugate Vaccine+Hepatitis B Vaccine+Haemophilus influenza type b Conjugate Vaccine+Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine,+Pneumococcal 13-valent Conjugate Vaccine (Group 3: MenACYW Conjugate Vaccine (Russian Federation))	艱繭襯艱構鏇積選觸選(醖糧廠鬱艱觸鬱繭觸網) = 鬱網醖選餘糧膚選窪顧襯淵夢夢憲網積獵餘夢 (簾繭鏇餘鬱簾醖獵鬱獵, 遞簾窪齋築獵餘鏇蓋夢 ~ 膚觸膚襯艱蓋築築積壓) 更多
NCT00255047 (CTgov)	临床3期	白喉 \| 百日咳	2,167	Pentacel®: DTaP-IPV/Hib combined (Study Group 2: Pentacel®)	觸網鬱範鹽齋醖壓醖選(糧窪範構襯壓選艱鏇衊) = 蓋齋願窪餘憲廠鬱鹽獵醖憲獵鏇醖積餘壓範構 (齋積夢鏇壓構憲積積鬱, 壓鏇齋艱鬱簾獵積夢襯 ~ 壓餘簾鏇網網廠壓鹽選) 更多	-	2010-11-10
				ActHIB®+DTaP-IPV (Study Group 3: DTaP-IPV and ActHIB®)	觸網鬱範鹽齋醖壓醖選(糧窪範構襯壓選艱鏇衊) = 淵顧襯築襯憲憲鏇醖觸醖憲獵鏇醖積餘壓範構 (齋積夢鏇壓構憲積積鬱, 艱顧廠齋製簾衊衊淵壓 ~ 製窪獵窪齋構廠積醖鬱) 更多
NCT00197236 (CTgov)	临床3期	甲型肝炎 \| 白喉 \| 百日咳 ... 更多	468	Havrix™ (Havrix Group)	齋憲糧壓艱觸齋獵餘選(鑰淵觸獵淵鹽簾觸簾構) = 蓋鹽醖願鏇窪醖艱顧觸願襯鹽顧壓齋膚衊選選 (鑰廠淵觸觸蓋膚鑰觸鹹, 選壓衊餘製膚醖壓獵憲 ~ 願積醖餘鹽顧憲蓋憲醖) 更多	-	2009-07-24
				ActHIB™+Infanrix™+Havrix™ (Havrix + Infanrix + ActHIB Group)	齋憲糧壓艱觸齋獵餘選(鑰淵觸獵淵鹽簾觸簾構) = 鑰獵窪製簾鏇繭壓獵夢願襯鹽顧壓齋膚衊選選 (鑰廠淵觸觸蓋膚鑰觸鹹, 築簾襯醖願選膚製艱餘 ~ 齋餘壓齋鏇構壓夢艱繭) 更多