b型流感嗜血杆菌结合 (成都生物制品研究所)(Haemophilus influenza type b conjugate vaccine(Chengdu Institute of Biological Products))

概要

基本信息

药物类型

预防性疫苗、结合疫苗

别名

Haemophilus Influenza Type b Conjugate Vaccine、b型流感嗜血杆菌结合疫苗（成都生物制品研究所）

靶点-

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

嗜血杆菌感染

非在研适应症-

原研机构

成都生物制品研究所有限责任公司

在研机构

成都生物制品研究所有限责任公司

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2013-06-03),

嗜血杆菌感染

最高研发阶段(中国)批准上市

特殊审评-

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关联

2

项与 b型流感嗜血杆菌结合 (成都生物制品研究所) 相关的临床试验

IRCT201008084536N1 / CompletedN/A

Study for Safety , immunogenicity and efficacy of intramuscular administration of Haemophilus Influenzae type b conjugate vaccine manufactured by Masoondarou Co. (MAS-HibVAC®) in 50 children and compare with foreign sample

开始日期2012-04-20

申办/合作机构-

NCT01404962 / Completed临床4期

A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea

This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.

开始日期2011-08-01

申办/合作机构-

100 项与 b型流感嗜血杆菌结合 (成都生物制品研究所) 相关的临床结果

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100 项与 b型流感嗜血杆菌结合 (成都生物制品研究所) 相关的转化医学

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100 项与 b型流感嗜血杆菌结合 (成都生物制品研究所) 相关的专利（医药）

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14

项与 b型流感嗜血杆菌结合 (成都生物制品研究所) 相关的文献（医药）

2023-08-01·Vaccine: X

A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India

Article

作者: Marthak, Kiran ; Sharma, Hitt ; Desai, Shivani ; Rao, Harish ; Pujari, Pramod ; Parekh, Sameer ; Shewale, Sunil ; Shaligram, Umesh ; Patel, Akash ; Gairola, Sunil

BackgroundTo assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and Haemophilus influenza type B conjugate adsorbed vaccine (DTaP-IPV + Hib), manufactured by Serum Institute of India Pvt. Ltd. (SIIPL)'s, the current first-in-human Phase 1 study was conducted in healthy adults.MethodsVaccine was administered as a single 0.5 mL dose intramuscularly into deltoid muscle of 24 healthy adults aged 18-45 years, who were then followed prospectively for one month for safety outcomes.ResultsAll 24 participants completed the study in compliance with protocol. Four solicited adverse events were reported in three participants during the study; all adverse events were mild and recovered completely. No deaths, unsolicited adverse events, or serious adverse events were reported.ConclusionSIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population.Clinical Trial Registration: CTRI/2017/07/009034.

2017-01-01·Vaccine3区 · 医学

Extensive swelling of the limb and systemic symptoms after a fourth dose of acellular pertussis containing vaccines in England in children aged 3–6 years

3区 · 医学

Article

作者: Southern, Jo ; Waight, Pauline A ; Miller, Elizabeth ; Andrews, Nick

Extensive limb swelling (ESL) after a booster dose of acellular pertussis (aP) containing vaccine can cause concern and has the potential to be confused with cellulitis. In the United Kingdom aP-containing vaccine was introduced for primary immunisation at 2, 3 and 4months of age in 2004, with the first cohorts eligible to receive a fourth dose in 2007 at school entry. We assessed the frequency of ESL (here defined as swelling >100mms diameter) in 973 children receiving a fourth dose of one of four aP vaccines given combined with inactivated polio, tetanus and either low dose diphtheria (TdaP/IPV) or high dose diphtheria (DTaP/IPV) vaccine; 2 of the 3 DTaP/IPV vaccines also contained Haemophilus influenza b conjugate vaccine (Hib). Post-vaccination symptoms and local reactions were recorded in 7-day diaries or by a telephone follow up if no diary was returned. Local swellings >50mm diameter were reported by 2.2% TdaP/IPV recipients compared with 6.6-11.1% of DTaP/IPV recipients; the corresponding proportions for redness >50mms was 7.0% for TdaP/IPV and 13.3-17.7% for DTaP/IPV recipients. Among the latter, the addition of Hib did not affect the frequency or size of local reactions. Pain at the injection site and systemic symptoms did not differ between the four vaccine groups. A history of atopy was not associated with development of local swelling or redness. A total of 13 children (1.3%) experienced an ESL, three after TdaP/IPV. ESLs resolved without systemic upset within a few days and were usually painless; medical advice was only sought for two children. Parents should be informed about the possible occurrence of an ESL with the pre-school aP-containing booster vaccine but can be reassured that it is a benign and transient condition.

2015-06-01·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Evaluation of safety of haemophilus influenza type b(Hib) conjugate vaccine in postmarketing based on the immunization information management system].

Article

作者: Zhang, Jinlin ; Gao, Jun ; Wang, Zhiguo ; Yu, Jing ; Ma, Fubao ; Kang, Guodong

OBJECTIVETo analyze the occurrence feature of adverse events following immunization (AEFI) of Hib conjugate vaccine (HibCV) and to evaluate the safety of HibCV in postmarketing.METHODS2008-2013 HibCV AEFI data were collected through national AEFI information management system, which were downloaded in March 18, 2014.The demographic information and inoculation quantity of HibCV were from Immunization information management system in Jiangsu province. The incidence rate and 95% CI value of AEFI, common vaccine reaction and rare vaccine reaction following immunization of HibCV were calculated. The differences in the incidence rate of common vaccine reaction and rare vaccine reaction among sex, months of age, and number of injections were compared by means of (χ² tests.RESULTSA total of 6.16 million doses of vaccine were administered in Jiangsu province during 2008-2013, and 4 718 vaccinees reported having adverse event, for a rate of 76.60/100 000 (95% CI: 74.42/100 000-78.79/100 000). The incidence rate of common vaccine reaction and rare vaccine reaction was 71.10/100 000 (95% CI: 68.99/100 000-73.20/100 000) and 5.16/100 000 (95% CI: 4.60/100 000-5.73/100 000), respectively. The main symptoms of common vaccine reactions were fever, swelling, indurations and gastrointestinal reactions. The incidence rates of them were 40.54/100 000, 35.09/100 000, 12.94/100 000 and 0.36/100 000 in turn. The main symptoms of rare vaccine reactions were anaphylactic rashes and angioedema, the incidence rates of which were 4.77/100 000 and 0.15/100 000 respectively. 91.39% (4 002/4 379) of common vaccine reactions and 88.36% (281/318) of rare vaccine reactions happened within 1 d after vaccination. Anaphylactic shock (3 cases) and laryngeal edema (1 case) all happened within 1 d after vaccination. The incidence rate of common vaccine reactions among boys (79.72/100 000, 2 641/3 313 071) was higher than that of girls (61.07/100 000, 1 738/2 846 001) (χ² = 74.92, P < 0.001). The incidence rate of common vaccine reactions among children aged ≥ 12 month-old (86.82/100 000, 2 200/2 533 949) was higher than that among children aged 2-11 month-old (60.11/100 000, 2 179/3 625 123) (χ² = 149.79, P < 0.001). The incidence rate of common vaccine reactions in children vaccinated the first dose (78.93/100 000, 2 666/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (61.59/100 000, 1 713/2 781 458) (χ² = 64.59, P < 0.001). The incidence rate of rare vaccine reactions in children vaccinated the first dose (6.69/100 000, 226/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (3.31/100 000, 92/2 781 458) (χ² = 33.82, P < 0.001).CONCLUSIONThe safety of HibCV among children was relative good. However, the surveillance should still focus on the anaphylactoid reactions of anaphylactic shock and laryngeal edema after HibCV immunization.

100 项与 b型流感嗜血杆菌结合 (成都生物制品研究所) 相关的药物交易

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