DTwP-HepB-Hib vaccine(Novartis Pharma AG)(DTwP-HepB-Hib vaccine(Novartis Pharma AG)) - 在研适应症：白喉，嗜血杆菌感染，乙型肝炎_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

DTP-HepB-Hib、DTwP-HepB-Hib、DTwP-HepB-Hib vaccine

+ [1]

靶点-

作用机制

免疫刺激剂

治疗领域

感染消化系统疾病呼吸系统疾病+ [1]

在研适应症

白喉嗜血杆菌感染乙型肝炎+ [2]

非在研适应症-

原研机构

Novartis Pharma AG

在研机构-

非在研机构

Novartis Vaccines & Diagnostics SLCrucell Holdings, Inc.

最高研发阶段批准上市

首次获批日期

韩国 (2006-03-01),

白喉嗜血杆菌感染乙型肝炎+ [2]

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 DTwP-HepB-Hib vaccine(Novartis Pharma AG) 相关的临床试验

NCT01470287 / Completed临床3期

A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age

This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.

开始日期2011-12-01

申办/合作机构-

CTRI/2011/07/001906 / Completed临床1期

An Open Labeled, Non comparative, Phase I Study to Evaluate the Safety and tolerability of a Fully Liquid Pentavalent DTwP-HepB-Hib Vaccine (My FiveTM, Panacea Biotec Ltd.) in Healthy Subjects 15 ? 18 months of age.

开始日期2011-07-21

申办/合作机构

Panacea Biotec Ltd.

100 项与 DTwP-HepB-Hib vaccine(Novartis Pharma AG) 相关的临床结果

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100 项与 DTwP-HepB-Hib vaccine(Novartis Pharma AG) 相关的转化医学

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100 项与 DTwP-HepB-Hib vaccine(Novartis Pharma AG) 相关的专利（医药）

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49

项与 DTwP-HepB-Hib vaccine(Novartis Pharma AG) 相关的文献（医药）

2024-12-31·Human Vaccines & Immunotherapeutics

Childhood vaccination trends during 2019 to 2022 in Tanzania and the impact of the COVID-19 pandemic

Article

作者: Mbwambo, Mbonea Erick ; Manyanga, Daudi Peter ; Tinuga, Florian ; Nyaki, Honesti ; Sangeda, Raphael Zozimus ; Mariki, Harrison ; James, Daniel ; Mwenesi, Mwendwa E

The COVID-19 pandemic has significantly disrupted healthcare systems at all levels globally, notably affecting routine healthcare services, such as childhood vaccination. This study examined the impact of these disruptions on routine childhood vaccination programmes in Tanzania. We conducted a longitudinal study over four years in five Tanzanian regions: Mwanza, Dar es Salaam, Mtwara, Arusha, and Dodoma. This study analyzed the trends in the use of six essential vaccines: Bacille Calmette-Guérin (BCG), bivalent Oral Polio Vaccine (bOPV), Diphtheria Tetanus Pertussis, Hepatitis-B and Hib (DTP-HepB-Hib), measles-rubella (MR), Pneumococcal Conjugate Vaccine (PCV), and Rota vaccines. We evaluated annual and monthly vaccination trends using time-series and regression analyses. Predictive modeling was performed using an autoregressive integrated moving average (ARIMA) model. A total of 32,602,734 vaccination events were recorded across the regions from 2019 to 2022. Despite declining vaccination rates in 2020, there was a notable rebound in 2021, indicating the resilience of Tanzania's immunization program. The analysis also highlighted regional differences in vaccination rates when standardized per 1000 people. Seasonal fluctuations were observed in monthly vaccination rates, with BCG showing the most stable trend. Predictive modeling of BCG indicated stable and increasing vaccination coverage by 2023. These findings underscore the robustness of Tanzania's childhood immunization infrastructure in overcoming the challenges posed by the COVID-19 pandemic, as indicated by the strong recovery of vaccination rates post-2020. We provide valuable insights into the dynamics of vaccination during a global health crisis and highlight the importance of sustained immunization efforts to maintain public health.

2023-12-04·West African journal of medicine

FACTORS INFLUENCING ANTI-POLYRIBOSYLRIBITOL PHOSPHATE TITRES IN YOUNG NIGERIAN CHILDREN PRIMED WITH DTWP-HEPB-HIB VACCINE.

作者: Shwe, David Danjuma ; Ebisike, Kelechi Joseph ; Yilgwan, Christopher Sabo ; Ozhe, Sunday Ikukpla'si ; Isaac, Johnson Ajeh ; Ocheke, Isaac Ejembi

IntroductionRecent research suggests that variation in vaccine-induced immune responses is influenced by genetic, nutritional, environmental, and vaccine-related factors, with significant vaccine design and programmatic policy implications. Haemophilus influenzae type b (Hib) Conjugate Vaccine (HCV) stimulates the production of antiPolyribosylribitol phosphate (anti-PRP) antibodies, which confer long-term protection against invasive Hib disease and nasopharyngeal colonization by Hib at titre levels ≥1μg/mL and ≥5μg/mL respectively. This study investigated the influence of these factors on the protective anti-PRP levels in children aged 6-23 months in Obi L.G.A. of Nasarawa State, Nigeria.MethodsThe study was a cross-sectional, two-stage household-level cluster survey involving 267 children who had completed the E.P.I. schedule of HCV-containing DTwP-HepB-Hib. Validated questionnaires were used for enrolment and relevant clinical and laboratory evaluations including anti-PRP, ABO/Rhesus antigens, and Haemoglobin genotype assays were conducted. Regression analyses were performed using Stata to explore the correlation between sociodemographic/vaccine-related factors, nutritional status, genotype, ABO/Rhesus antigens, and protective anti-PRP titres.ResultsBivariate analysis showed that age, breastfeeding practice, household size/under-five number, nutritional, socioeconomic, Measles/Yellow fever vaccination, and Rhesus statuses were significantly associated with anti-PRP titre. However, multivariate analysis revealed that age between 6-11 months (AOR=3.12,95%CI=1.15-8.50), households with less than three under-fives (AOR=2.33,95%CI=1.14-4.78), middle socioeconomic class (AOR=3.15,95%CI=1.42-6.98), wasting (AOR=2.27,95%CI=1.23-4.22) and Measles/Yellow fever vaccination (AOR=2.90,95%CI=1.38-6.07) were significantly correlated with protective anti-PRP titres.ConclusionResults indicate that the family and socioeconomic milieu influence anti-PRP titre, and Measles/Yellow fever vaccines may have a beneficial non-specific effect on HCV-induced seroprotection in Nigerian children.

2023-06-01·Vaccine

Immunogenicity of the pentavalent DTwP-HB-Hib vaccine (Shan-5) used in the Thai Expanded Program on Immunization compared to the hexavalent DTaP-HB-Hib-IPV and DTwP-HB-Hib (Quinvaxem) vaccines administered to infants at 2, 4, 6 months of age

Article

作者: Sarawanangkoor, Nasiri ; Thongmee, Thanunrat ; Posuwan, Nawarat ; Srimuan, Donchida ; Wanlapakorn, Nasamon ; Phanphanit, Kanchana ; Pruetarat, Napa ; Poovorawan, Yong ; Thatsanathorn, Thaksaporn

BACKGROUNDThe pentavalent DTwP-HB-Hib (Shan-5) vaccine was first introduced into the Thailand Expanded Program on Immunization (EPI) in 2019. The Shan-5 vaccine is administered to infants at 2, 4, and 6 months of age, after initial vaccination with monovalent hepatitis B (HepB) and Bacillus Calmette-Guérin (BCG) vaccines at birth. This study compared the immunogenicity of the HepB, diphtheria, tetanus, and Bordetella pertussis antigens incorporated in the EPI Shan-5 vaccine versus the optional pentavalent (DTwP-HB-Hib) Quinvaxem and hexavalent (DTaP-HB-Hib-IPV) Infanrix-hexa vaccine.METHODSThree-dose Shan-5-vaccinated children were prospectively enrolled at the Regional Health Promotion Centre 5, Ratchaburi province, Thailand, between May 2020 and May 2021. Blood sampling was performed at months 7 and 18. The levels of HepB surface antibody (anti-HBs), anti-diphtheria toxoid (DT) IgG, anti-tetanus toxoid (TT) IgG, and anti-pertussis toxin (PT) IgG were evaluated using commercially available enzyme-linked immunoassays.RESULTSAnti-HBs levels of ≥10 mIU/mL were achieved in 100 %, 99.2 %, and 99.2 % of infants in the Shan-5 EPI group, hexavalent group and Quinvaxem group one month after four dose immunization (at 0, 2, 4, 6 months of age), respectively. The geometric mean concentrations of the EPI Shan-5 and hexavalent groups were comparable but were higher than those of the Quinvaxem group. At one month after primary vaccination (month 7), infants in the Shan-5 EPI group had significantly higher levels of anti-DT IgG, anti-TT IgG, and anti-PT IgG than infants in the hexavalent and Quinvaxem groups.CONCLUSIONSThe immunogenicity of the HepB surface antigen in the EPI Shan-5 vaccine was similar to that achieved by the hexavalent vaccine, but was higher than that achieved by the Quinvaxem vaccine. The Shan-5 vaccine is highly immunogenic and generates robust antibody responses after primary immunization.

100 项与 DTwP-HepB-Hib vaccine(Novartis Pharma AG) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J07CA11	-

研发状态

批准上市

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适应症	国家/地区	公司	日期
白喉	韩国	-	2006-03-01
嗜血杆菌感染	韩国	-	2006-03-01
乙型肝炎	韩国	-	2006-03-01
破伤风	韩国	-	2006-03-01
百日咳	韩国	-	2006-03-01

未上市

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3期	越南	Crucell Holdings, Inc.	2010-04-01
嗜血杆菌感染	临床3期	越南	Crucell Holdings, Inc.	2010-04-01
乙型肝炎	临床3期	越南	Crucell Holdings, Inc.	2010-04-01
破伤风	临床3期	越南	Crucell Holdings, Inc.	2010-04-01
百日咳	临床3期	越南	Crucell Holdings, Inc.	2010-04-01