DTwP-Hib vaccine (Serum Institute of India)(DTwP-Hib vaccine (Serum Institute of India)) - 在研适应症：破伤风，嗜血杆菌感染，白喉_专利_临床

概要

基本信息

药物类型

联合疫苗、预防性疫苗

别名

Quadrovax、Quadrovax PFS、Quadrovax SD

靶点-

作用机制

免疫遗传刺激剂

治疗领域

感染呼吸系统疾病其他疾病

在研适应症

破伤风嗜血杆菌感染白喉+ [1]

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-

最高研发阶段批准上市

首次获批日期

印度 (2007-12-08),

百日咳

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 DTwP-Hib vaccine (Serum Institute of India) 相关的临床试验

CTRI/2020/01/022898 / Completed临床1期IIT

A single centre open label phase-I study to evaluate the safety and reactogenicity of single dose of BE’s liquid quadrivalent DTwP-Hib vaccine administered intramuscularly to 16-24 month old healthy Indian toddlers. - None

开始日期2020-01-27

申办/合作机构-

CTRI/2010/091/001125 / Completed临床1/2期

A PHASE I/II (PILOT) RANDOMIZED SINGLE BLIND TRIAL TO COMPARE THE SAFETY AND IMMUNOGENECITY OF TETRABHAY DTwP-H COMBINATION VACCINE WITH SHANTETRA TM IN HEALTHY CHILDREN

开始日期2010-09-08

申办/合作机构-

100 项与 DTwP-Hib vaccine (Serum Institute of India) 相关的临床结果

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100 项与 DTwP-Hib vaccine (Serum Institute of India) 相关的转化医学

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100 项与 DTwP-Hib vaccine (Serum Institute of India) 相关的专利（医药）

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22

项与 DTwP-Hib vaccine (Serum Institute of India) 相关的文献（医药）

2022-12-30·Human Vaccines & Immunotherapeutics

Safety and immunogenicity of a combined DTacP-sIPV-Hib vaccine in animal models

Article

作者: Zhao, Yuxiu ; Yang, Xiaoming ; Zhang, Yuntao ; Wu, Chongyang ; Wang, Hui ; Dong, Yuan ; Liu, Yingwei ; Li, Shihui ; Yu, Shouzhi ; Li, Wanli ; Huang, Yunchao ; Yang, Baifeng ; Wei, Xiaoli ; Zhang, Yadan ; Guo, Yancen

The DTacP-sIPV-Hib combination vaccine can replace the single-component acellular pertussis, diphtheria, tetanus, polio, and Haemophilus influenzae type B vaccines. In this study, we evaluated the safety and immunogenicity of a newly developed DTacP-sIPV-Hib combination vaccine in animal models. We used 40 mice and 46 cynomolgus monkeys to evaluate acute and long-term toxicity. Thirty-six guinea pigs were used for sensitization assessment. For immunogenicity assessment, 50 NIH mice and 50 rats were equally randomized to receive 3 doses of 3 different batches of the tested vaccine at an interval of 21 d, or physiological saline solution (0.5 mL). Orbital blood was collected at an interval of 21 d post inoculation to detect related antibody titers or neutralizing antibody titers against poliovirus. Gross autopsy and histopathological examination revealed no abnormal toxicity or irritation in mice and cynomolgus monkeys. Sensitization assessment in guinea pigs indicated the lack of evident allergic symptoms in the high- and low-dose vaccine groups within 30 min after repeated stimulation. The DTacP-sIPV-Hib combination vaccine induced significant immune responses in mice, rats, and cynomolgus monkeys, with 100% seroconversion rates after 3 doses. The DTacP-sIPV-Hib combination vaccine is safe and immunogenic in animal models. Three doses of the vaccine elicited satisfactory antibody responses in mice, rats, and cynomolgus monkeys.

2017-09-02·Human Vaccines & Immunotherapeutics3区 · 医学

A randomized, open-label clinical trial to evaluate immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Easyfour®-TT) with Quadrovax® in Indian infants

3区 · 医学

Article

作者: Sharma, Sunil ; Panwar, Sachin ; Chilkoti, Deepak Chandra ; Behera, Beauty ; Paliwal, Charu ; Gupta, Anu ; Mohanty, Lalitendu ; Singh, Anit

An open-label, randomized, multi-center trial was conducted to compare the immunogenicity and safety of an indigenously developed tetravalent DTwP-Hib vaccine, Easyfour®-TT with a commercially available vaccine, Quadrovax®. A total of 244 infants in good health, aged 6-10 weeks, were randomized in a 1:1 allocation to receive three doses of the test or comparator vaccine. Immunogenicity of the vaccines was determined by measuring the baseline and post-vaccination antibody response against the vaccine antigens; safety was evaluated in terms of local and systemic reactions (solicited and unsolicited) reported during the trial. Similar levels of seroprotection/seroresponse were achieved, 4 weeks after receiving 3 doses of Easyfour®-TT and Quadrovax®, and the antibody response of Easyfour®-TT was found non-inferior to Quadrovax®, against all four vaccine antigens. Both vaccines were well tolerated and had similar reactogenicity profiles, with a significantly lower occurrence of local (redness at injection site) and systemic reactions (irritability post-vaccination) with Easyfour®-TT vaccine as compared to Quadrovax® (p < 0.05). All adverse events resolved completely with no sequelae. All through the study, only one serious adverse event was observed that completely resolved upon treatment and was deemed unrelated to the vaccine administered. This study demonstrated that Easyfour®-TT vaccine was safe and immunogenic.CLINICAL TRIAL REGISTRATION NUMBERCTRI/2014/12/005326 (registered with the Clinical Trial Registry of India (CTRI)).

2015-09-01·Archives de Pédiatrie4区 · 医学

Réaction locale étendue à un vaccin pentavalent

4区 · 医学

Article

作者: Gébus, M ; Plantaz, D ; Bost-Bru, C ; Michard-Lenoir, A P ; Barbier, C

Injection site reactions (ISRs) are quite common side effects defined by a local adverse drug reaction directly caused by a vaccine. Twenty-four hours after an intramuscular injection (in the deltoid muscle) of the diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, Haemophilus influenza type b (DTPCa-Hib) combined vaccine, a 3-year-old boy developed fever. A few hours later, local redness and swelling appeared at the injection site, with rapid extension to the entire limb, it was pain-free, and no other clinical anomalies were present. The patient received intravenous antibiotics for suspected cellulitis. The progression was favorable in 12h (apyrexia and decreased limb swelling), allowing the intravenous antibiotic treatment to be discontinued. Since the child was in excellent general health and recovery was fast, an ISR was diagnosed. Extensive limb swelling is frequent, mostly after the fourth dose of DTPCa-Hib. Deltoid muscle injection of DTP vaccine increases the risk of ISR compared to injection in the thigh, before the age of 3 years. The introduction of acellular pertussis vaccine decreased the risk of general side effects but may increase the risk of ISR. These reactions disappear with symptomatic treatment and do not contraindicate the product.

100 项与 DTwP-Hib vaccine (Serum Institute of India) 相关的药物交易

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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
破伤风	印度	Serum Institute of India Pvt Ltd.	2008-01-24
嗜血杆菌感染	印度	Serum Institute of India Pvt Ltd.	2008-01-22
白喉	印度	Serum Institute of India Pvt Ltd.	2007-12-12
百日咳	印度	Serum Institute of India Pvt Ltd.	2007-12-08