Heptavalent combination vaccine(GlaxoSmithKline Plc)(Heptavalent combination vaccine(GlaxoSmithKline Plc))

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

Heptavalent combination vaccine、Heptavalent conjugated vaccine

+ [2]

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染神经系统疾病消化系统疾病+ [2]

在研适应症-

非在研适应症

白喉嗜血杆菌感染乙型肝炎+ [4]

原研机构

GSK Plc

在研机构-

非在研机构

GSK Plc

权益机构-

最高研发阶段终止临床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

5

项与 Heptavalent combination vaccine(GlaxoSmithKline Plc) 相关的临床试验

RPCEC00000182

/ Completed临床2/3期IIT

Immunogenicity and efficacy of Heptavalent Conjugate Vaccine against Pneumococcal (VCN7-T) in healthy children. Phase II/III. - ISCANI

开始日期2014-06-09

申办/合作机构

Finlay Institute of Cuba

NCT01171989

/ Completed临床2期

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose in 12-18 Months Old Healthy Children

The current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).

开始日期2010-08-18

申办/合作机构

GSK Plc

NCT01090453

/ Completed临床2期

Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 4 and 12 Months of Age

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.

开始日期2010-05-17

申办/合作机构

GSK Plc

100 项与 Heptavalent combination vaccine(GlaxoSmithKline Plc) 相关的临床结果

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100 项与 Heptavalent combination vaccine(GlaxoSmithKline Plc) 相关的转化医学

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100 项与 Heptavalent combination vaccine(GlaxoSmithKline Plc) 相关的专利（医药）

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289

项与 Heptavalent combination vaccine(GlaxoSmithKline Plc) 相关的文献（医药）

2023-02-01·Archives of Virology

Assessment of the potency and effectiveness of a heptavalent oil-adjuvanted (ISA 206) foot-and-mouth disease vaccine in Egypt

Article

作者: Badr, Yassien ; Wasfy, Momtaz ; Magouz, Asmaa ; Nayel, Mohamed ; Amer, Haitham M ; El-Sayed, Magdy M ; Maklad, Nada ; Attia, Mohamed ; Bazid, Abdel-Hamid ; Abdelmegeid, Mohamed

AbstractFoot-and-mouth disease (FMD) is a serious highly contagious viral disease affecting all cloven-hoofed animals, and outbreaks can have a severe economic impact. An inactivated heptavalent oil-adjuvanted FMD vaccine (Aphtovac-7, MEVAC) was prepared from the foot-and-mouth disease virus (FMDV) strains A-Iran05, A-Africa-IV, O-PanAsia2, O-Manisa, O-EA3, SAT-2 Gharbia, and SAT-2 LIB-12. The vaccine potency and effectiveness were evaluated in three groups of 6- to 8-month-old calves and 200 adult dairy cattle under field conditions. All animals were vaccinated with the vaccine preparation, and the three groups of calves were challenged after 28 days by intradermolingual inoculation with 104 50% tissue culture infective dose (TCID50) of FMDV serotype A, O, or SAT-2. Mock-vaccinated calves (two per group) served as unvaccinated controls during the challenge test. Adult dairy cattle were tested for seroconversion using a virus neutralization test at 30, 60, and 120 days post-vaccination. All calves displayed complete protection against challenge with the different serotypes of FMDV when compared to the control groups. Serum samples collected after the primary and booster immunizations at 30 days post-vaccination contained high titers of protective antibodies (≥ 1/32; i.e. 1.5 log10). Antibodies persisted until the end of the study period (120 days), with a peak value around 60 days post-vaccination. The heptavalent FMD vaccine preparation was found to be potent and capable of providing a protective immune response under both experimental and field conditions.

2017-05-19·Immunological Investigations3区 · 医学

Influence of the Co-Administration of Heptavalent Conjugate Vaccine PCV7-TT on the Immunological Response Elicited by VA-MENGOC-BC® and Heberpenta®-L in Rabbits

3区 · 医学

Article

作者: Nicot, Milagros ; Martin, Yanet ; Valdés, Yury ; Valle, Orialys ; Espinosa-Viñals, Carlos ; Núñez, Juan F ; Vérez Bencomo, Vicente ; García-Rivera, Dagmar ; Santana, Darielys ; Amador Gómez, Aylín ; Rodríguez Noda, Laura

Finlay Vaccine Institute is developing a new heptavalent conjugate vaccine against Streptococcus pneumoniae. As infants are the target population, PCV7-TT will be necessarily co-administered with other vaccines, and then, the interactions represent a concern. The aim of this work is to evaluate the possible immunological interferences in rabbits as animal experimental model. Rabbits were immunized with Heberpenta®-L, VA-MENGOC-BC®, and PCV7-TT. Blood samples were taken fourteen days after final immunization for obtaining sera. Antibody responses to all antigens were evaluated by indirect ELISA. Functional responses against diphtheria and tetanus toxoid were done by in vivo seroneutralization assay. No interference was observed by PCV7-TT over the humoral response against diphtheria toxoid and meningococcal antigens (p > 0.05). A nonstatistically significant reduction (p > 0.05) was observed in the case of the humoral response against Haemophilus influenzae type b oligosaccharide. Concomitant administration of Heberpenta®-L and PCV7-TT increased twice the antibody titers as well as the protective activity against tetanus toxoid, but no statistical differences were found. The co-administration did not induce a reduction in the percent of responders against pneumococcal polysaccharides contained in PCV7-TT vaccine. Concomitant administration of PCV7-TT did not induce interferences over the evaluated antigens of Heberpenta®-L and VA-MENGOC-BC®. Also, no interference was observed on the immune response elicited by PCV7-TT. These preclinical results suggest that PCV7-TT will not result in a serious problem over the immune response elicited by the licensed vaccines Heberpenta®-L and VA-MENGOC-BC®. However, the clinical interference could be strictly studied during clinical trials in infants.

2017-03-01·Pediatric Infectious Disease Journal4区 · 医学

Etiology of Acute Otitis Media in Children Less Than 5 Years of Age

4区 · 医学

Article

作者: Lopez, Pio ; Al-Mazrou, Khalid ; Pirçon, Jean-Yves ; Madhi, Shabir A ; Naranjo, Laura ; Pumarola, Felix ; Hausdorff, William P ; Rosenblüt, Andrés ; Cohen, Robert ; Macias Parra, Mercedes ; Sonsuwan, Nuntigar ; Van Dyke, Melissa K ; Grevers, Gerhard

BACKGROUNDAcute otitis media (AOM) is an important cause of childhood morbidity and antibiotic prescriptions. However, the relative importance of the well-known otopathogens, Streptococcus pneumoniae (Spn) and Haemophilus influenzae (Hflu), remains unclear because of a limited number of tympanocentesis-based studies that vary significantly in populations sampled, case definitions and heptavalent pneumococcal conjugate vaccine use.METHODSWe conducted a pooled analysis of results from 10 AOM etiology studies of similar design, the protocols of which were derived from a common protocol and conducted in children 3 months to 5 years of age in different countries. Generalized estimating equations were used to account for within-study correlations.RESULTSThe majority, 55.5% (95% confidence interval: 47.0%-65.7%) of 1124 AOM episodes, were bacterial pathogen positive: 29.1% (24.8%-34.1%) yielded Hflu and 23.6% (19.0%-29.2%) Spn. Proportions of Hflu and Spn were higher and lower, respectively, in heptavalent pneumococcal conjugate vaccine-vaccinated children. Hflu and Spn were each isolated from 20% to 35% of children in every 1-year age range. Hflu was less likely to be isolated from first (vs. subsequent) episodes [relative risk (RR): 0.71 (0.60-0.84)]. Spn was more often isolated from sporadic (vs. recurrent) cases [RR: 0.76 (0.61-0.97)]; the opposite was true for Hflu [RR: 1.4 (1.00-1.96)]. Spn cases were more likely to present with severe (vs. mild) symptoms [RR: 1.42 (1.01-2.01)] and Hflu cases with severe tympanic membrane inflammation [RR: 1.35 (1.06-1.71)].CONCLUSIONSSpn and Hflu remain the leading otopathogens in all populations examined. While associated with overlapping symptoms and severity, they exhibit some differences in their likelihood to cause disease in specific subpopulations.

100 项与 Heptavalent combination vaccine(GlaxoSmithKline Plc) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
白喉	临床2期	斯洛伐克	GSK Plc	2009-04-01
白喉	临床2期	斯洛伐克	GSK Plc	2009-04-01
乙型肝炎	临床2期	斯洛伐克	GSK Plc	2009-04-01
乙型肝炎	临床2期	斯洛伐克	GSK Plc	2009-04-01
脑膜炎	临床2期	斯洛伐克	GSK Plc	2009-04-01
脊髓灰质炎	临床2期	斯洛伐克	GSK Plc	2009-04-01
脊髓灰质炎	临床2期	斯洛伐克	GSK Plc	2009-04-01
百日咳	临床2期	斯洛伐克	GSK Plc	2009-04-01
百日咳	临床2期	斯洛伐克	GSK Plc	2009-04-01
脑膜炎	药物发现	斯洛伐克	GSK Plc	2009-04-01

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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


NCT00970307 (CTgov)	临床2期	白喉 \| 乙型肝炎 \| 脑膜炎 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风 \| 脊髓灰质炎	421	10-valent pneumococcal vaccine (GSK 1024850A)+GSK2202083A vaccine (GSK2202083A + Synflorix Group)	顧糧憲廠鬱齋鑰繭鹽廠(築襯糧鏇壓膚遞簾鹽淵) = 鏇夢顧壓鬱壓遞鏇鏇遞淵淵艱構繭築構鹽淵顧 (糧遞糧鹽餘鏇膚範範遞, 範範構鑰糧艱顧製鹽積 ~ 淵襯窪襯鏇鹽鏇製齋窪) 更多	-	2017-04-14
				Menjugate®+Infanrix hexa™ (Infanrix Hexa + Menjugate Group)	顧糧憲廠鬱齋鑰繭鹽廠(築襯糧鏇壓膚遞簾鹽淵) = 範鬱淵鹽選製壓願繭襯淵淵艱構繭築構鹽淵顧 (糧遞糧鹽餘鏇膚範範遞, 糧願積醖蓋淵築選淵餘 ~ 簾衊齋鹽衊艱壓憲窪襯) 更多
NCT01171989 (CTgov)	临床2期	白喉 \| 脑膜炎 \| 乙型肝炎 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风 \| 脊髓灰质炎	391	Synflorix™+GSK2202083A vaccine (GSK2202083A + Synflorix Group)	鹽選築製範積艱鬱艱鬱(鬱獵淵鑰積獵壓夢襯鬱) = 範鬱餘鹹糧糧蓋鑰淵鬱廠範構選鏇獵淵窪範壓 (鬱艱襯廠製選膚艱鏇顧, 範膚範蓋膚淵築製築醖 ~ 網範積選構醖襯鹹鹹艱) 更多	-	2017-04-11
				Menjugate™+Infanrix hexa™ (Infanrix Hexa/Menjugate Group)	鹽選築製範積艱鬱艱鬱(鬱獵淵鑰積獵壓夢襯鬱) = 衊餘醖襯鹽選觸鑰蓋網廠範構選鏇獵淵窪範壓 (鬱艱襯廠製選膚艱鏇顧, 鹽蓋簾網廠積積鏇網餘 ~ 糧艱積範繭鹹廠餘繭鑰) 更多
NCT00871741 (CTgov)	临床2期	白喉 \| 脑膜炎 \| 乙型肝炎 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风 \| 脊髓灰质炎	16	GSK2202083A vaccine (GSK2202083A Group)	糧窪網構艱鹹廠鬱範遞(蓋鏇繭遞觸遞窪淵窪艱) = 鹹鬱製製鏇鏇襯簾壓襯襯鹽窪壓製鹹鹹鏇襯鹽 (衊鹽築膚糧壓淵繭糧簾, 襯鬱鬱積獵選憲顧艱齋 ~ 壓齋淵鏇淵製艱膚壓顧) 更多	-	2017-04-04
				Menjugate+Infanrix hexa (Infanrix + Menjugate Group)	糧窪網構艱鹹廠鬱範遞(蓋鏇繭遞觸遞窪淵窪艱) = 艱廠蓋壓獵鏇鏇築鹽餘襯鹽窪壓製鹹鹹鏇襯鹽 (衊鹽築膚糧壓淵繭糧簾, 觸積獵構鹹製網襯積觸 ~ 餘鹽窪襯艱鹽齋廠鬱選) 更多
NCT01090453 (CTgov)	临床2期	白喉 \| 乙型肝炎 \| 脑膜炎 \| 嗜血杆菌感染 \| 百日咳 \| 破伤风 \| 脊髓灰质炎	480	GSK2202083A vaccine+Rotarix™+Prevenar 13® (GSK2202083A Group)	鏇鹹鹹廠遞衊齋鏇鏇範(顧餘窪鑰遞齋窪壓憲鑰) = 衊鹽積鬱齋壓簾繭網範簾衊艱觸糧繭窪繭網糧 (繭艱壓壓淵壓淵範夢憲, 廠夢獵鑰鑰構鹽廠獵遞 ~ 壓範蓋鑰選繭簾壓積鏇) 更多	-	2014-08-15
				Menjugate®+Infanrix hexa™+Rotarix™+Prevenar 13® (Infanrix Hexa Group)	鏇鹹鹹廠遞衊齋鏇鏇範(顧餘窪鑰遞齋窪壓憲鑰) = 製網憲鹹糧襯糧繭鏇壓簾衊艱觸糧繭窪繭網糧 (繭艱壓壓淵壓淵範夢憲, 鑰鬱遞築齋願積顧簾蓋 ~ 鹹築繭艱壓膚願積觸夢) 更多