A Phase-III multicentric randomized open label, active Controlled study to evaluate the Immunogenicity and Safety of BBILs combination of DTwPHib (Comvac4) vaccine in comparison with Reference Vaccine Comvac3â?¢ BioHib in healthy infants of 6 to 7 weeks age - Comvac4

开始日期2017-01-25

申办/合作机构

Bharat Biotech International Ltd.

100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的临床结果

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100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的转化医学

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100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的专利（医药）

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项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的文献（医药）

2018-04-01·Vaccine3区 · 医学

A randomized, open label trial to evaluate and compare the immunogenicity and safety of a novel liquid hexavalent DTwP-Hib/Hep B-IPV (EasySix™) to licensed combination vaccines in healthy infants

3区 · 医学

Article

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

Immunogenicity and safety of a newly developed liquid DTwP-Hib/HepB-IPV hexavalent vaccine (EasySix™) was evaluated and compared with administration of commercially licensed Pentavac SD® (DTwP-HepB/Hib) and Imovax Polio® vaccine in an open-label, randomized multi-centric trial. 284 participants, aged 6-10weeks, randomized in a 1:1 allocation, received three doses of test or comparator vaccines, administered 4weeks apart. Immunogenicity of the vaccines was determined by measuring the baseline and post-vaccination antibody responses and comparing the proportions of subjects achieving seroprotection against the vaccine antigens; safety was evaluated in terms of solicited (local and systemic) and unsolicited incidences in the follow up phase. Post-vaccination, seroprotection was achieved against all six vaccine antigens in both vaccine groups. The seroresponse rate as well as geometric mean titers of antibody for all vaccine components were comparable between EasySix™ and Pentavac SD®-Imovax Polio® group. Both vaccines had similar reactogenicity profiles and were well tolerated; all adverse events resolved completely without any sequelae. Only one serious adverse event was reported that completely resolved; it was regarded unconnected to the vaccine administered. This study demonstrated that immunogenicity and safety profiles of EasySix™ vaccine, manufactured by Panacea Biotec Ltd, are non-inferior to the commercially available vaccines.CLINICAL TRIAL REGISTRATIONCTRI/2015/02/005578.

2015-09-01·Biologicals4区 · 生物学

Patterns of binding of aluminum-containing adjuvants to Haemophilus influenzae type b and meningococcal group C conjugate vaccines and components

4区 · 生物学

Article

作者: Crane, Dennis T ; Amir, Saba Erum ; Bolgiano, Barbara ; Otto, Robert B D ; Burkin, Karena

The basis of Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroup C (MenC) glycoconjugates binding to aluminum-containing adjuvants was studied. By measuring the amount of polysaccharide and protein in the non-adsorbed supernatant, the adjuvant, aluminum phosphate, AlPO4, was found to be less efficient than aluminum hydroxide, Al(OH)3 at binding to the conjugates, at concentrations relevant to licensed vaccine formulations and when equimolar. At neutral pH, binding of TT conjugates to AlPO4 was facilitated through the carrier protein, with only weak binding of AlPO4 to CRM197 being observed. There was slightly higher binding of either adjuvant to tetanus toxoid conjugates, than to CRM197 conjugates. This was verified in AlPO4 formulations containing DTwP-Hib, where the adsorption of TT-conjugated Hib was higher than CRM197-conjugated Hib. At neutral pH, the anionic Hib and MenC polysaccharides did not appreciably bind to AlPO4, but did bind to Al(OH)3, due to electrostatic interactions. Phosphate ions reduced the binding of the conjugates to the adjuvants. These patterns of adjuvant adsorption can form the basis for future formulation studies with individual and combination vaccines containing saccharide-protein conjugates.

2013-08-01·Pediatric Infectious Disease Journal4区 · 医学

Antibody Persistence and Booster Vaccination of a Fully Liquid Hexavalent Vaccine Coadministered With Measles/Mumps/Rubella and Varicella Vaccines at 15–18 Months of Age in Healthy South African Infants

4区 · 医学

Article

作者: Santos-Lima, Eduardo ; Groome, Michelle ; Madhi, Shabir A ; Cutland, Clare ; Koen, Anthonet

OBJECTIVETo assess antibody persistence and booster immunogenicity and safety of a new, fully liquid, hexavalent DTaP-IPV-Hep B-PRP-T vaccine.METHODSPhase III, open-label, 2-center trial. Infants previously primed at 6, 10, 14 weeks of age with DTaP-IPV-Hep B-PRP-T either without (group 1: N = 218) or with hepatitis B at birth (group 3: N = 130) or control DTwP-Hib, hepatitis B and oral poliovirus vaccine vaccines (group 2: N = 219) received the same vaccine(s) as booster (except hepatitis B for group 2) at 15-18 months of age, coadministered with measles/mumps/rubella and varicella vaccines (MMR+V). All participants had received measles vaccine at 9 months of age. Antibodies were measured prebooster and 1 month postbooster vaccination. Safety was evaluated from parental reports. Analyses were descriptive.RESULTSAntibody persistence (seroprotection and concentration) at 15-18 months of age was high for each valence and similar in each group, except for Hep B (highest in group 3 [extra dose of hepatitis B]) and PRP (highest in group 2). Postbooster seroprotection (D, T, IPV, Hep B, PRP) and seroconversion (pertussis toxin and filamentous hemagglutinin) rates were high and similar in each group (excluding Hep B in group 2 [no booster]); geometric mean antibody levels increased markedly in all groups. The response to MMR+V was similar in each group. All vaccines were well tolerated.CONCLUSIONSA booster dose of the new DTaP-IPV-Hep B-PRP-T vaccine at 15-18 months of age is highly immunogenic and safe compared with licensed comparators, following primary series administration in the Expanded Program on Immunization schedule, with or without a hepatitis B vaccine at birth and coadministered with MMR+V.

项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 相关的新闻（医药）

2024-01-30

·生物制品圈

世卫组织预认证（PQ）疫苗优先列表，优推联苗、RSV、轮状疫苗等

截至2023年12月，我国共有10个疫苗产品11个规格通过预认证，且有十余个候选疫苗计划在未来提交预认证申请。《预认证疫苗优先列表》由世卫组织与联合国儿童基金会和泛美卫生组织循环基金协商后设立，标明各种疫苗的世卫组织PQ优先级别。世卫组织每两年更新一次列表，按照高、中、低和无四个优先级别对预计在两年期结束前可供应的疫苗进行分类。疫苗的优先次序指导世卫组织将有限的预认证资源集中用于优先疫苗，并支持国家免疫计划实现其目标。上一版本的优先列表为2018-2022年。2023年11月，世卫组织更新了2024-2026年度预认证疫苗优先列表如下。在此分享给中国疫苗企业，可选择高中优先级疫苗申请PQ。高优先级疫苗1.霍乱疫苗2.登革热四价疫苗3.六联苗：全细胞百白破-乙型肝炎-b型流感嗜血杆菌-脊髓灰质炎灭活疫苗（DTwP-HepB-Hib-IPV）4.人类乳头瘤病毒(HPV)疫苗5.疟疾疫苗6.麻疹-风疹(MR)二联疫苗7.麻疹-腮腺炎-风疹(MMR)三联疫苗 8.脑膜炎球菌ACWY群结合疫苗9.脑膜炎球菌ACWYX群结合疫苗10.肺炎链球菌结合疫苗11.新型口服单价2型脊髓灰质炎(nOPV2)疫苗12.轮状病毒疫苗13.呼吸道合胞病毒(RSV)疫苗14.伤寒结合疫苗15.黄热疫苗中优先级疫苗1.卡介苗2.埃博拉疫苗3.甲肝疫苗4.乙肝疫苗5.戊肝疫苗6.麻疹疫苗7.口服二价1,3型脊髓灰质炎活疫苗 (bOPV1,3) 8.口服单价1型脊髓灰质炎活疫苗(mOPV1)9.狂犬疫苗10.水痘疫苗11.基孔肯雅病毒疫苗低优先级疫苗1.儿童白喉-破伤风(DT)疫苗2.成人白喉-破伤风(Td)疫苗3.基于DTwP的四联混合全液体(DTwP-Hep B-Hib)疫苗4.无细胞百白破-Hep B-Hib-IPV六联疫苗5.季节性流感NH和SH疫苗 *6.乙型脑炎疫苗 7.含A群脑膜炎球菌的结合疫苗8.肺炎链球菌多糖疫苗9.脊髓灰质炎灭活疫苗(IPV)10.Sabin 株脊髓灰质炎灭活-疫苗(sIPV)11.口服单价2型脊髓灰质炎活疫苗(mOPV2)12.口服单价3型脊髓灰质炎活疫苗(mOPV3)13.口服三价脊髓灰质炎活疫苗(tOPV)*如果使用生产速度更快的技术平台，则优先级可提升为中等。无优先级疫苗1.白喉-破伤风-全细胞百日咳(DTwP)疫苗2.白喉-破伤风-无细胞百日咳(DTaP)疫苗3.DTwP+Hib(液体-冻干)四联疫苗4.DTwP-Hib(全液体)四联疫苗5.DTwP-Hep B四联疫苗6.基于DTwP的五联疫苗(液体-冻干)(DTwP-Hep B+Hib)7.b型流感嗜血杆菌(Hib)疫苗8.应急储备用甲型H1N1流感疫苗9.含脑膜炎球菌CW群结合疫苗10.脑膜炎球菌AC群多糖疫苗11.脑膜炎球菌ACWY群多糖疫苗12.风疹疫苗13.破伤风类毒素(TT)疫苗14.伤寒多糖疫苗如果产品开发工作已经完成并能满足公共卫生需求，本双年度期间考虑以下潜在的候选疫苗：1.COVID-19疫苗2.新型OPV1、3与2型的联合疫苗 3.猴痘疫苗4.结核病(TB)疫苗5.志贺氏菌疫苗6.B群链球菌疫苗7.s19-IPV疫苗识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

疫苗临床研究

100 项与 Diphtheria tetanus pertusis-hepatitis B vaccine(Bharat Biotech International Ltd.) 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

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适应症	国家/地区	公司	日期
白喉	印度	Bharat Biotech International Ltd.	2016-02-19
乙型肝炎	印度	Bharat Biotech International Ltd.	2016-02-19
破伤风	印度	Bharat Biotech International Ltd.	2016-02-19
百日咳	印度	Bharat Biotech International Ltd.	2016-02-19