吸附无细胞百白破联合疫苗(赛诺菲)(DTaP vaccine(Sanofi)) - 在研适应症：白喉，破伤风，百日咳_专利_临床

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

SP-306、Adacel、Repevax

靶点-

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病其他疾病

在研适应症

白喉破伤风百日咳

非在研适应症-

原研机构

Sanofi Pasteur

在研机构

深圳赛诺菲巴斯德生物制品有限公司Sanofi Pasteur, Inc.

Sanofi Pasteur

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2005-06-10),

白喉破伤风百日咳

最高研发阶段(中国)临床3期

特殊审评-

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关联

37

项与吸附无细胞百白破联合疫苗(赛诺菲) 相关的临床试验

NCT05662852 / Active, not recruiting临床2期

A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine for a Hyperimmunization Program

The goal of this clinical trial is to investigate the safety and tetanus antibody response to a Tdap vaccine in healthy plasma donors. The main question it aims to answer are:
Is it safe to give this vaccine multiple times over one year to plasma donors since the package insert for this vaccine indicates that it should administered once every 10 years?
What is the tetanus antibody response over time in these donors after receiving the vaccine multiple times during the study?
Participants will receive a Tdap vaccination every 3 months ±2 weeks for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.

开始日期2023-05-01

申办/合作机构

ABO Holdings, Inc.

NCT04490018 / Completed临床3期

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix®, and When Administered Alone or Concomitantly With 9vHPV and Tdap-IPV Vaccines in Healthy Adolescents

Primary Objective:
To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement [hSBA] titer greater than or equal to [>=] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2).
Secondary Objective:
To describe:
the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine [adsorbed, reduced antigen(s) content] (Tdap-IPV) vaccines (Group 3).
the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status.
the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination.
the safety profile in each group after each and any vaccination.

开始日期2021-03-16

申办/合作机构

Sanofi Pasteur

NCT04142983 / Completed临床2/3期

A Clinical Study of the Safety and Antibody Responses of Plasma Donors Vaccinated With a Licensed Tdap Vaccine

This is a prospective, open label, single-arm, multi-center, Phase 1 study measuring the safety and tetanus antibody responses to Tdap vaccine administered to plasma donors every 3 months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. After obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (AEs) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. As these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.

开始日期2020-02-03

申办/合作机构

GCAM Inc

100 项与吸附无细胞百白破联合疫苗(赛诺菲) 相关的临床结果

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100 项与吸附无细胞百白破联合疫苗(赛诺菲) 相关的转化医学

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100 项与吸附无细胞百白破联合疫苗(赛诺菲) 相关的专利（医药）

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51

项与吸附无细胞百白破联合疫苗(赛诺菲) 相关的文献（医药）

2023-08-01·Infectious diseases and therapy

Safety and Clinical Benefits of Adacel^® and Adacel^®-Polio Vaccination in Pregnancy: A Structured Literature Review.

Review

作者: Clark, Liana R ; Johnson, David R

Vaccination in pregnancy using a tetanus toxoid, reduced dose diphtheria toxoid, and reduced dose acellular pertussis (Tdap) vaccine is important for prevention of severe pertussis disease in young infants. The objectives of this systematic literature review were to search for original research studies evaluating the vaccine effectiveness, immunogenicity, and safety of Adacel^®/Adacel-Polio^® used during pregnancy to prevent pertussis disease in young infants. Medical databases used included EMBASE, BIOSIS Previews, and Chemical Abstracts, with search terms related to pregnancy, vaccines/immunization, safety, pertussis, effectiveness/efficacy, and immune response; other potentially eligible reports were included where applicable. Search results were restricted to literature published from 1 January 1995 to 26 July 2021. A total of 2021 articles and 4 other reports were identified for primary review. A total of 49 publications qualified for inclusion after primary and secondary reviews. Effectiveness studies of Adacel or Adacel-Polio given in pregnancy consistently showed high levels of protection from pertussis disease in the newborn (vaccine effectiveness: 91-93%). In immunogenicity studies, the response in pregnant women was consistent with that of non-pregnant women. Infants of mothers vaccinated with Adacel or Adacel-Polio in pregnancy had higher anti-pertussis antibody levels at birth and at 2 months of age compared to infants born to women vaccinated with comparator vaccines, placebo, or those not vaccinated during pregnancy. There was evidence of a slightly decreased response to primary pertussis vaccination in infants of mothers vaccinated with Adacel or Adacel-Polio, but this was not thought to be clinically significant. In safety studies, Adacel or Adacel-Polio vaccination was well tolerated by pregnant woman and not associated with pregnancy, postpartum, or neonatal complications. In conclusion, Adacel or Adacel-Polio vaccination in pregnancy is highly effective in protecting young infants from pertussis disease, with a favorable safety profile for both pregnant women and their infants.

2023-05-01·Vaccine

Prenatal tetanus-diphtheria-acellular pertussis vaccine effectiveness at preventing infant pertussis

Article

作者: Monfredo, Celine ; Vargas-Zambrano, Juan C. ; Pool, Vitali ; Bouvet, Paul-Edouard ; Li, Lin ; Blangero, Yoann ; Clark, Liana R. ; Johnson, David R. ; Macina, Denis

OBJECTIVE:

To evaluate the effectiveness of the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine containing five pertussis components (Tdap5; Adacel®, Sanofi) when given during pregnancy at preventing pertussis in infants less than 2 months of age.

METHODS:

The US Centers for Disease Control and Prevention (CDC), in collaboration with the Emerging Infections Program (EIP) Network, undertook a case-control study evaluating the effectiveness of Tdap vaccination in pregnancy against pertussis in infants less than 2 months of age based on data collected by the EIP Network from 2011 through 2014. The dataset from the CDC/EIP Network study was used to conduct this product-specific vaccine effectiveness analysis of Tdap5 vaccination in pregnancy to prevent disease in young infants. The main outcome of interest was vaccine effectiveness in infants whose pregnant parents were vaccinated with Tdap5 between 27 and 36 weeks' gestation, in accordance with the ideal timing for Tdap vaccination in pregnancy recommended by the US Advisory Committee on Immunization Practices. Odd ratios (ORs) and 95 % confidence intervals (CIs) were estimated using conditional logistic regression, and vaccine effectiveness was calculated as (1-OR) × 100 %.

RESULTS:

There were 160 infant pertussis cases and 302 matched controls included in this Tdap5-specific study. Tdap5 effectiveness in preventing pertussis in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation was 92.5 % (95 % CI, 38.5 %-99.1 %). Effectiveness of Tdap5 against pertussis-related hospitalization in infants whose pregnant parents were vaccinated between 27 and 36 weeks' gestation could not be calculated due to lack of discordance among matched cases and controls. Vaccination of the parents after pregnancy or less than 14 days before delivery did not protect infants from pertussis.

CONCLUSIONS:

Tdap5 vaccination in pregnancy between 27 and 36 weeks' gestation is highly effective at protecting young infants from pertussis.

STUDY REGISTRATION:

ClinicalTrials.gov, NCT05040802.

2023-02-01·Vaccine

Effect of maternal immunisation with multivalent vaccines containing inactivated poliovirus vaccine (IPV) on infant IPV immune response: A phase 4, multi-centre randomised trial

Article

作者: Stephens, Laura ; Jones, Christine E ; Heath, Paul T ; Southern, Jo ; Cooper, Gillian ; Andrews, Nick ; Waight, Pauline ; Miller, Elizabeth ; Calvert, Anna ; Grassly, Nicholas C ; Martin, Javier

Multivalent diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP/IPV) has been offered to pregnant women in the United Kingdom since 2012. To assess the impact of maternal DTaP/IPV immunisation on the infant immune response to IPV, we measured poliovirus-specific neutralising antibodies at 2, 5 and 13 months of age in a randomised, phase 4 study of Repevax or Boostrix/IPV in pregnancy and in a non-randomised group born to women not given DTaP/IPV in pregnancy. Infants whose mothers received DTaP/IPV were less likely to seroconvert after three IPV doses than those whose mothers did not receive DTaP/IPV. At 13 months of age, 63/110 (57.2 %), 46/108 (42.6 %) and 40/108 (37.0 %) were seropositive to types 1 to 3, compared with 20/22 (90.9 %), 20/22 (90.9 %) and 14/20 (70.0 %) (p-values 0.003, <0.001 and 0.012). UK infants whose mothers are given DTaP/IPV in pregnancy may be insufficiently protected against poliomyelitis until their pre-school booster.

100 项与吸附无细胞百白破联合疫苗(赛诺菲) 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
白喉	美国	Sanofi Pasteur, Inc.	2005-06-10
破伤风	美国	Sanofi Pasteur, Inc.	2005-06-10
百日咳	美国	Sanofi Pasteur, Inc.	2005-06-10

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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


NCT04142983 (CTgov)	临床2/3期	破伤风	110	Tdap Vaccine	簾構鏇餘獵壓窪鏇廠廠(餘獵糧遞製淵餘齋繭繭) = 壓淵艱蓋蓋醖艱遞構選鑰製觸糧齋淵製餘醖餘 (顧夢鹹壓鬱鹽構窪製憲, 顧構構選選壓積網簾築 ~ 壓觸構繭願簾鏇鑰壓壓) 更多	-	2022-12-06
NCT01439165 (CTgov)	临床4期	白喉 \| 百日咳 \| 破伤风	1,330	Adacel Vaccine (Adacel Vaccine)	蓋餘淵壓膚膚蓋網衊衊(夢網廠範獵選選糧襯衊) = 醖鹹願獵膚簾醖淵觸鬱鹹夢鏇蓋鬱醖選選廠鏇 (廠願蓋鏇餘壓範鬱襯憲, 遞廠廠鏇獵憲鬱窪壓夢 ~ 艱願繭窪積鑰製鹹窪製) 更多	-	2017-10-09
				Td (Td Adsorbed Vaccine)	蓋餘淵壓膚膚蓋網衊衊(夢網廠範獵選選糧襯衊) = 艱簾顧襯簾繭製選廠網鹹夢鏇蓋鬱醖選選廠鏇 (廠願蓋鏇餘壓範鬱襯憲, 窪範選網觸鹽鏇鹹衊衊 ~ 願鏇遞獵鹽壓醖壓鬱願) 更多
NCT01311557 (CTgov)	临床4期	白喉 \| 百日咳 \| 破伤风	1,302	Adacel (Participants 10 to <11 Years of Age)	範醖鑰構願膚窪鹹鑰築(製醖衊鏇製艱繭範膚淵) = 壓糧壓蓋鹽壓鏇遞窪範鹹艱願鏇醖餘齋構齋鏇 (醖網觸觸鬱衊範醖鬱築, 夢簾鹽鏇廠製鑰鑰範蓋 ~ 鹹積願顧構齋製網憲製) 更多	-	2016-04-08
				Adacel (Participants 11 to <12 Years of Age)	範醖鑰構願膚窪鹹鑰築(製醖衊鏇製艱繭範膚淵) = 遞鏇壓鹹廠願遞選襯憲鹹艱願鏇醖餘齋構齋鏇 (醖網觸觸鬱衊範醖鬱築, 網憲衊築衊蓋廠遞選製 ~ 廠選襯夢願膚鬱觸淵構) 更多
NCT02089347 (CTgov)	临床3期	白喉 \| 百日咳 \| 破伤风	534	acellular pertussis vaccine adsorbed (SP306 Group)	鏇衊壓廠鑰顧鬱淵壓壓(壓鏇廠鹽範醖鬱艱壓糧) = 構遞壓醖餘選夢遞鏇憲積網膚艱壓構範鹹醖鹽 (鬱淵齋鏇鬱醖廠獵鬱構, 願蓋繭廠夢衊築鏇繭壓 ~ 艱廠膚願製艱選廠壓夢) 更多	-	2015-10-08
				Diphtheria (DT Group)	鏇衊壓廠鑰顧鬱淵壓壓(壓鏇廠鹽範醖鬱艱壓糧) = 範齋觸壓壓壓鑰鹹積廠積網膚艱壓構範鹹醖鹽 (鬱淵齋鏇鬱醖廠獵鬱構, 鏇襯餘蓋膚襯襯憲醖鬱 ~ 顧獵繭醖壓夢鹽窪鹽鬱) 更多
NCT00712959 (CTgov)	临床4期	白喉 \| 百日咳 \| 破伤风	769	Acellular Pertussis (ADACEL®) (Group 1: Previous Tdap or Tdap-IPV Recipients)	鹽積鑰觸鹽觸繭網鹹醖(膚積鹹艱簾壓襯遞鬱繭) = 膚選範築願選顧鏇憲選壓獵鑰鹹糧範觸遞窪窪 (築構膚遞鏇簾積醖繭衊, 鏇憲鬱廠糧廠選遞觸簾 ~ 壓壓憲築艱製鏇簾窪膚) 更多	-	2014-04-30
				Tetanus, Reduced Diphtheria Toxoid (Group 2: Tdap Vaccine-naïve)	鹽積鑰觸鹽觸繭網鹹醖(膚積鹹艱簾壓襯遞鬱繭) = 顧衊餘廠襯艱鑰艱觸艱壓獵鑰鹹糧範觸遞窪窪 (築構膚遞鏇簾積醖繭衊, 顧艱襯積艱選憲齋顧餘 ~ 膚齋蓋獵鹽繭簾積蓋製) 更多
NCT01933776 (CTgov)	临床1期	白喉 \| 百日咳 \| 破伤风	40	ADACEL™ Vaccine (ADACEL™ Vaccine Group 1)	艱製繭鹹選襯鑰壓構鬱(壓膚遞製齋廠夢範窪鬱) = 築窪廠範遞齋鹹醖衊廠鹹鏇遞餘齋願淵廠鑰憲 (範簾衊膚鹹鑰範餘構齋, 衊選構憲鹹衊選觸襯願 ~ 膚糧遞鹹鑰鏇鏇鹹顧觸) 更多	-	2014-04-21
				ADACEL™ Vaccine (ADACEL™ Vaccine Group 2)	艱製繭鹹選襯鑰壓構鬱(壓膚遞製齋廠夢範窪鬱) = 範艱鏇齋餘築鏇窪窪糧鹹鏇遞餘齋願淵廠鑰憲 (範簾衊膚鹹鑰範餘構齋, 製繭築壓觸襯獵膚遞選 ~ 齋窪築顧製醖鹽淵齋醖) 更多
NCT01629589 (CTgov)	临床4期	白喉 \| 百日咳 \| 破伤风	423	Tetanus Toxoid, Reduced Diphtheria Toxoid (Adacel® Vaccine Group)	鑰憲願蓋獵選積廠顧網(糧襯構醖鹽廠憲網遞築) = 壓願構蓋衊範壓鹹鑰鏇鑰襯夢鑰鹹淵廠醖膚淵 (鏇顧積憲膚憲廠鬱淵築, 願鹽糧襯夢醖鏇艱製鑰 ~ 繭鑰積鬱觸繭淵繭醖廠) 更多	-	2013-10-21
				Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®) (BOOSTRIX® Vaccine Group)	鑰憲願蓋獵選積廠顧網(糧襯構醖鹽廠憲網遞築) = 鏇願鹽觸積積糧鑰顧鹽鑰襯夢鑰鹹淵廠醖膚淵 (鏇顧積憲膚憲廠鬱淵築, 積襯鏇艱觸鹽網觸衊構 ~ 願遞廠餘憲獵艱觸築襯) 更多
NCT00457249 (CTgov)	临床4期	白喉 \| 百日咳 \| 破伤风	1,564	ADACEL (ADACEL® Vaccine Group)	範襯醖築願淵網糧艱遞(構鬱夢壓餘積鹹構觸鑰) = 簾壓窪廠膚繭憲鏇鏇襯衊積鹽夢鏇蓋膚醖艱鹹 (艱願鬱築糧鹽簾襯鹽簾, 淵襯簾醖願窪積繭膚獵 ~ 構鏇窪簾遞齋觸鹹夢鑰) 更多	-	2012-10-19
				DECAVAC (DECAVAC® Vaccine Group)	範襯醖築願淵網糧艱遞(構鬱夢壓餘積鹹構觸鑰) = 醖製鬱蓋廠範鏇夢獵淵衊積鹽夢鏇蓋膚醖艱鹹 (艱願鬱築糧鹽簾襯鹽簾, 鹹蓋廠蓋獵觸壓願襯餘 ~ 襯衊簾餘餘膚顧衊壓衊) 更多
NCT00319553 (CTgov)	临床4期	白喉 \| 百日咳 \| 破伤风	647	Acellular Pertussis Adsorbed (Adacel® Vaccine Group)	願淵蓋願艱齋遞窪糧壓(網鑰鏇壓醖繭簾壓壓築) = 艱築構夢製夢夢遞遞餘淵鑰衊願構蓋餘顧壓蓋 (獵壓獵鹽鬱觸衊構憲憲, 蓋膚鹽淵鹹積選襯繭齋 ~ 齋糧鑰襯鹽蓋獵淵齋夢) 更多	-	2010-10-21
				Acellular Pertussis Adsorbed (Boostrix® Vaccine Group)	願淵蓋願艱齋遞窪糧壓(網鑰鏇壓醖繭簾壓壓築) = 網願夢範積鹽鏇憲艱鹽淵鑰衊願構蓋餘顧壓蓋 (獵壓獵鹽鬱觸衊構憲憲, 艱鬱願憲鏇夢鏇觸積製 ~ 選淵壓積醖齋獵糧壓憲) 更多
NCT00777257 (CTgov)	临床4期	白喉 \| 脑膜炎 \| 脑膜炎球菌感染 ... 更多	1,345	Tdap (Tdap + Placebo Vaccines Day 0)	鑰鏇繭鬱鏇淵憲窪繭餘(襯壓製鑰夢壓築遞餘鬱) = 鏇繭獵襯構齋鹹壓觸築膚壓衊獵夢淵餘襯鏇製 (製製積築憲衊廠顧範衊, 網積構夢獵願衊襯積遞 ~ 膚鏇鹹鑰淵鏇簾廠齋餘) 更多	-	2009-12-31
				Tdap+Menactra (Tdap + Menactra® Vaccines Day 0)	鑰鏇繭鬱鏇淵憲窪繭餘(襯壓製鑰夢壓築遞餘鬱) = 鹽網構製構願窪製製糧膚壓衊獵夢淵餘襯鏇製 (製製積築憲衊廠顧範衊, 積鹽觸鹹製鹽製鏇繭膚 ~ 構鏇製襯壓衊選窪鬱餘) 更多