Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India)(Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India)) - 在研适应症：乙型肝炎，嗜血杆菌感染，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、结合疫苗

别名

DTPwHBHib vaccine、Diphtheria Tetanus Pertussis Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed Serum Institute of India、Pentavac PFS

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

乙型肝炎嗜血杆菌感染百日咳+ [2]

非在研适应症-

原研机构

Serum Institute of India Pvt Ltd.

在研机构

Serum Institute of India Pvt Ltd.

非在研机构

The Company for Vaccine & Biological Production No. 1

最高研发阶段批准上市

首次获批日期

印度 (2008-11-25),

破伤风

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India) 相关的临床试验

NCT03931239 / CompletedN/A

An Open Label, Multicentric, Bridging Study to Assess the Safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Manufactured by Serum Institute of India Pvt. Ltd in Vietnamese Infants Aged 6-12 Weeks, Given as a 3-dose Regime, With 4 Week Intervals Between the Doses

The objective of this study is to evaluate safety and tolerability of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine Adsorbed in Vietnamese infants aged 6-12 weeks. This is an open label, single group, bridging study.

开始日期2018-03-01

申办/合作机构

The Company for Vaccine & Biological Production No. 1

[+1]

NCT02409095 / Terminated临床4期

A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Healthy Infants In India

This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment.
It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.

开始日期2015-01-01

申办/合作机构

Serum Institute of India Pvt Ltd.

[+1]

NCT02097472 / Completed临床1/2期IIT

A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers

The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV).
Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.

开始日期2014-04-01

申办/合作机构

Program for Appropriate Technology in Health

100 项与 Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India) 相关的临床结果

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100 项与 Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India) 相关的转化医学

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100 项与 Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India) 相关的专利（医药）

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28

项与 Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India) 相关的文献（医药）

2024-12-01·Vaccine

A randomized, active-controlled, multi-centric, phase-II clinical study to assess safety and immunogenicity of a fully liquid DTwP-HepB-IPV-Hib hexavalent vaccine (HEXASIIL®) in Indian toddlers

Article

作者: Ravi, M.D. ; Ramanan, Padmasani Venkat ; Pujari, Pramod ; Gautam, Manish ; Shewale, Sunil ; Gairola, Sunil ; Agarwal, Anurag ; Jaganathan, K S ; Jaganathan, K.S. ; Desai, Shivani ; Kumar, Rakesh ; Dogar, Vikas ; Sharma, Hitt ; Parekh, Sameer ; Sharma, Inderjit ; Kamath, Veena ; Lalwani, Sanjay ; Ravi, M D ; Kawade, Anand

BACKGROUNDCombination vaccines are effective in simplifying complex vaccination schedules involving multiple vaccines. A fully liquid hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)- hepatitis B (HepB)-inactivated poliovirus (IPV)-Haemophilus influenzae b (Hib) vaccine (HEXASIIL®), manufactured by Serum Institute of India Pvt. Ltd. was tested for safety and immunogenicity following booster vaccination.METHODSThis was a phase-II/III, open label, multicentric, controlled trial in toddlers (phase II) and infants (phase III) in India. This manuscript presents results of phase II. Healthy toddlers aged 12-24 months were randomized (1:1) to receive a 0.5 ml booster dose of HEXASIIL® or comparator Pentavac SD + Poliovac, intramuscularly and followed for 28 days for safety assessment. Blood samples were collected pre-vaccination and 28 days post-vaccination to assess immunogenicity. Descriptive summary statistics were provided for safety and immunogenecity analyses.RESULTSA total of 223 subjects were randomized. One subject droped out prior to dosing, due to consent withdrawal. Thus, 222 subjects received study vaccine (110 HEXASIIL® and 112 comparator). Frequency of solicited adverse events was comparable between HEXASIIL® and comparator (85.5 % vs 90.2 %). Most local and systemic solicited AEs were mild to moderate in severity. All events resolved completely without any sequelae and none led to subject discontinuation. No vaccine related serious AE was reported. Post vaccination, seroprotection rates against tetanus, Hib and polio type 1 and 3 were 100 % in both the groups. Seroprotection rates for diphtheria (99.1 % vs 100 %) and polio type 2 (98.2 % vs 100 %) were observed in HEXASIIL® and comparator group, respectively. For Hepatitis B, seroprotection was >99 % in both groups. Seroconversion observed for Bordetella Pertussis (94.5 % vs 95.4 %) and Pertussis Toxin (77.1 % vs 87.2 %) in HEXASIIL® and comparator group, respectively.CONCLUSIONHEXASIIL® vaccine was found to be safe and immunogenic in toddlers and supported its further clinical development in infants. Clinical Trial Registration - CTRI/2019/11/022052.

2023-01-01·Science in One Health

Human health implications of emerging diseases and the current situation in India's vaccine industry

Review

作者: Jena, Anway Kumar ; Behera, Bhaskar ; Bhattacharya, Manojit ; Behera, Jiban Kumar ; Mishra, Pabitra

Emerging diseases are infectious diseases that pose significant threat to human health, causing millions of deaths and disabilities in the upcoming days. Periodic epidemics of new infections and old reinfections increase the global burden of disease prevalence. They can be caused by new pathogens or evolving ones, which change human behavior and environmental factors. Researchers have studied the dynamic connections between microbes, hosts, and the environment, but new infectious diseases like coronavirus disease 2019 (COVID-19), re-emerging diseases, and deliberately disseminated diseases persist despite earlier hopes of elimination. With heavy privatesector investments, Indian pharmacology now provides core Expanded Programme on Immunization vaccines to United Nations International Children's Emergency Fund, producing previously unattainable vaccines for diseases like meningitis, hepatitis B, pneumococcal conjugate, rotavirus, influenza A (H1N1), and COVID-19. India's vaccine sector has emerged, among the oriented leaders of the Bharat Biotech, Serum Institute of India, Panacea Biotech and Biological E. Specifically, the technology transferred from Western countries has benefited the sector, which produces 1.3 billion doses annually. The Serum Institute is the world's largest manufacturer of vaccines, providing measles and diphtheria-tetanus-pertussis vaccines to United Nations. The Serum Institute has developed several vaccines, including Nasovac, MenAfriVac, Pentavac, and an inactivated polio vaccine. India's success in vaccinations can be attributed to attractive investment conditions, government assistance, international alliances, and rising domestic technical talent. Despite its booming economy and technical advances, India's disproportionate share of the world's child mortality rate remains unchanged. However, the growing production and distribution of vaccinations in developing nations has initiated a new era, leading to a worldwide decline in childhood death and disease.

2022-09-15·Molecular Biology of the Cell

Cardiac inducing colonies halt fibroblast activation and induce cardiac/endothelial cells to move and expand via paracrine signaling

Article

作者: Mahapatra, Samiksha ; Gallicano, Vaughn E. ; Gallicano, G. Ian ; Sharma, Michael V. R. ; Brownson, Breanna

Cardiac inducing colonies generated from germline stem cells secrete at least 18 paracrine factors that promote a full spectrum of events involved in cardiac regeneration. Events include preventing fibroblast activation (scarring), myocyte movement, and myocyte cell cycle up-regulation.

100 项与 Adsorbed Hib-DTP-hepatitis B vaccine (Serum Institute of India) 相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
乙型肝炎	印度	Serum Institute of India Pvt Ltd.	2009-01-09
嗜血杆菌感染	印度	Serum Institute of India Pvt Ltd.	2008-12-18
百日咳	印度	Serum Institute of India Pvt Ltd.	2008-12-15
白喉	印度	Serum Institute of India Pvt Ltd.	2008-12-14
破伤风	印度	Serum Institute of India Pvt Ltd.	2008-11-25

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	药物发现	越南	The Company for Vaccine & Biological Production No. 1	-
嗜血杆菌感染	药物发现	越南	The Company for Vaccine & Biological Production No. 1	-
乙型肝炎	药物发现	越南	The Company for Vaccine & Biological Production No. 1	-
破伤风	药物发现	越南	The Company for Vaccine & Biological Production No. 1	-
百日咳	药物发现	越南	The Company for Vaccine & Biological Production No. 1	-