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更新于：2025-05-12
Haemophilus b conjugate vaccine(GSK Plc)
更新于：2025-05-12
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基本信息
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21
项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的临床试验NCT03893448
A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
NCT03620162
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
NCT03621670
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的临床结果
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100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的转化医学
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100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的专利（医药）
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203
项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的文献（医药）2025-01-31Open Forum Infectious Diseases
Real-World Effectiveness of 3 Types of Acellular Pertussis Vaccines Among Children Aged 3 Months–16 Years in Lu’an, China: A Matched Case-Control Study
Article
作者: Qin, Wei ; Zhang, Huan ; Tian, Yongjie ; Ma, Liguo ; Ma, Bingxin ; Zhao, Changjun ; Liu, Yongyu ; Pan, Fan ; Zhou, Yu ; Wang, Yao ; Chen, Yafei
Abstract:
Background:
The real-world vaccine effectiveness (VE) of the diphtheria, tetanus, and acellular pertussis (DTaP), DTaP–Haemophilus influenzae type b (Hib), and DTaP–inactivated polio (IPV)/Hib vaccines has not been thoroughly evaluated in China. Additionally, there are limited data on the VE of acellular pertussis–containing vaccines (aPVs) when used interchangeably.
Methods:
We conducted a matched case-control study to estimate the VE of aPVs against polymerase chain reaction–confirmed pertussis infection in Lu’an in 2024. A conditional logistic regression model was used to compare the odds ratios (ORs) of vaccination between cases and controls. VE was calculated as [(1 – adjusted OR) × 100%], and 95% confidence intervals (CIs) were computed around the estimates.
Results:
A total of 1936 children aged 3 months to 16 years were included in the study. The overall VE was 77.3% (95% CI, 35.2%–92.1%). The VE for fully vaccinated children was 88.4% (95% CI, 57.3%–96.8%), while the VE for partially vaccinated children was 77.4% (95% CI, 35.5%–92.1%). The VE of DTaP, DTaP-Hib, and DTaP-IPV/Hib was 75.8% (95% CI, 29.7%–91.7%), 83.2% (95% CI, 47.8%–94.6%), and 79.8% (95% CI, 36.5%–93.6%), respectively. Compared with mixed vaccination (65.3%.), the incremental VE of DTaP, DTaP-Hib, and DTaP-IPV/Hib was 31.0% (95% CI, 1.0%–51.9%), 52.9% (95% CI, 19.1%–72.6%), and 41.1% (95% CI, −18.7% to 71.8%), respectively. We observed a decline in VE over time, decreasing from 76.5% (95% CI, 33.0%–91.7%) within the first 2 years to −5.5% (95% CI, −495.2% to 81.3%) after 6 years or more.
Conclusions:
All aPVs provide significant protection against pertussis infection, although this protection wanes over time. The VE appears to decrease materially if these vaccines are administered alternately in an individual's routine immunization schedule.
2024-12-31Human Vaccines & Immunotherapeutics
Adverse events following immunization of co- and separate administration of DTaP-IPV/Hib vaccines: A real-world comparative study
Article
作者: Li, Jing ; Zhu, Yiqing ; Wang, Yihan ; Wang, Jinghui ; Wang, Yafei ; Guo, Yu ; Wang, Lina ; Sun, Li
To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.
2024-12-01The Lancet regional health. Southeast Asia
Routine immunization against Streptococcus pneumoniae and Haemophilus influenzae type B and antibiotic consumption in India: a dynamic modeling analysis
Article
作者: Parameswaran, Giridara Gopal ; Gleason, Alec C ; Klein, Eili ; Laxminarayan, Ramanan ; Kumar, Chirag K ; Gleason, Alec C. ; Nandi, Arindam ; Kumar, Chirag K. ; Summan, Amit
Background:
Childhood vaccinations can reduce disease burden and associated antibiotic use, in turn reducing the risk of antimicrobial resistance (AMR). We retrospectively estimated the population-level reductions in antibiotic use in India following the introduction of vaccines against Streptococcus pneumoniae and Haemophilius influenzae type B in the national immunization program for children in the mid-2010s and projected future gains to 2028 if vaccination coverage were to be increased.
Methods:
Using IndiaSim, a dynamic agent-based microsimulation model (ABM) for India, we simulated the spread of Streptococcus pneumoniae and Haemophilius influenzae type B (Hib) among children to estimate reductions in antibiotic use under the scenarios of: (i) pneumococcal and Hib vaccine coverage levels equivalent to the national coverage of pentavalent diphtheria-pertussis-tetanus third dose (DPT3) compared to a baseline of no vaccination, and (ii) near-universal (90%) coverage of the vaccines compared to pre-COVID national DPT3-level coverage. Model parameters, including national DPT3 coverage rates, were based on data from the National Family Household Survey 2015-2016 and other published sources. We quantified reductions in antibiotic consumption nationally and by state and wealth quintiles.
Findings:
We estimate that coverage of S. pneumoniae and Hib vaccines at the same level as DPT3 in India would translate to a 61.4% [95% UI: 43.8-69.5] reduction in attributable antibiotic use compared to a baseline of zero vaccination coverage. Increases in childhood vaccination coverage between 2004 and 2016 have likely reduced attributable antibiotic demand by as much as 93.4% among the poorest quintile. Increasing vaccination coverage by an additional 11 percentage points from 2016 levels results in mortality and antibiotic use across wealth quintiles becoming increasingly similar (p < 0.05), reducing in health inquities. We project that near-universal vaccine coverage would further reduce inequities in antibiotic demand and may eliminate of outbreak-associated antibiotic use from S. pneumoniae and Hib.
Interpretation:
Though vaccination has a complex relationship with antibiotic use because both are modulated by socioeconomic factors, increasing vaccinations for S. pneumoniae and Hib may have a significant impact on reducing antibiotic use and improving health outcomes among the poorest individuals.
Funding:
The Bill & Melinda Gates Foundation (grant numbers OPP1158136 and OPP1190803).
100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的药物交易
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外链
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 嗜血杆菌感染 | 美国 | 2009-08-19 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 轮状病毒感染 | 临床3期 | 美国 | 2017-09-14 | |
| 轮状病毒引起的病毒性胃肠炎 | 临床3期 | 美国 | 2017-09-14 | |
| 链球菌感染 | 临床3期 | 美国 | 2008-06-10 | |
| 脑膜炎球菌感染 | 临床3期 | 菲律宾 | 2005-06-16 | |
| 脑膜炎球菌感染 | 临床3期 | 泰国 | 2005-06-16 | |
| 白喉 | 临床3期 | - | 2000-09-01 | |
| 乙型肝炎 | 临床3期 | - | 2000-09-01 | |
| 脊髓灰质炎 | 临床3期 | - | 2000-09-01 | |
| 破伤风 | 临床3期 | - | 2000-09-01 | |
| 百日咳 | 临床3期 | - | 2000-09-01 |
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临床结果
临床结果
适应症
分期
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临床3期 | 1,280 | (HRV Porcine Circovirus (PCV)-Free Liquid Group) | 製膚範築鏇築獵獵積獵 = 構窪獵衊構壓顧鹹製艱 襯積襯製衊鬱衊觸範淵 (鬱憲網網獵窪淵鏇鏇憲, 網餘壓鏇繭選網遞鑰觸 ~ 遞壓壓範齋築糧繭顧願) 更多 | - | 2019-10-31 | ||
(HRV Lyophilized Group) | 製膚範築鏇築獵獵積獵 = 願網遞壓艱構鬱構蓋鹽 襯積襯製衊鬱衊觸範淵 (鬱憲網網獵窪淵鏇鏇憲, 壓艱簾壓鹽憲艱壓網齋 ~ 衊餘獵艱網淵鏇鬱鏇積) 更多 | ||||||
临床2期 | 301 | (SB692342 2 Dose Group) | 鑰鑰窪淵壓製蓋鹽構觸 = 膚築鹹膚衊鏇鬱願壓網 夢繭繭糧顧繭鬱膚繭膚 (夢構鑰夢簾壓壓願鬱製, 構蓋鏇窪觸襯廠鏇繭艱 ~ 糧齋築範願範鬱願製繭) 更多 | - | 2018-11-27 | ||
(SB692342 1 Dose Group) | 鑰鑰窪淵壓製蓋鹽構觸 = 觸夢觸鬱襯選顧網膚衊 夢繭繭糧顧繭鬱膚繭膚 (夢構鑰夢簾壓壓願鬱製, 網築糧繭窪遞憲鹹衊齋 ~ 製積構構糧廠憲糧鏇夢) 更多 | ||||||
临床3期 | 296 | (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group) | 繭鏇艱夢蓋襯鑰淵遞艱 = 鑰艱壓壓簾構艱遞築夢 鏇觸鹹膚醖構顧積繭繭 (獵壓鑰膚願襯積膚製範, 壓淵夢鏇選鹹製願鑰蓋 ~ 廠顧餘餘醖鏇範鹹廠廠) 更多 | - | 2017-08-03 | ||
(Tritanrix-HepB/Hiberix+Mencevax ACWY Group) | 繭鏇艱夢蓋襯鑰淵遞艱 = 遞壓簾壓簾蓋獵廠築淵 鏇觸鹹膚醖構顧積繭繭 (獵壓鑰膚願襯積膚製範, 選廠範積艱構壓憲蓋鏇 ~ 淵膚願選鹽願醖膚積範) 更多 | ||||||
临床3期 | 168 | (Tritanrix-HepB/Hiberix Group) | 鏇網齋襯糧鏇糧衊選遞 = 淵簾廠壓獵構觸壓選築 夢顧鏇窪鏇夢製餘繭艱 (廠獵觸窪顧鬱製膚網範, 顧齋淵蓋夢襯觸膚壓選 ~ 鹽齋鹹壓製衊製積膚選) 更多 | - | 2017-03-01 | ||
Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group) | 鏇網齋襯糧鏇糧衊選遞 = 餘窪糧鹹艱壓觸製鹽鹽 夢顧鏇窪鏇夢製餘繭艱 (廠獵觸窪顧鬱製膚網範, 壓襯範艱鏇衊襯鹽構遞 ~ 顧餘窪鹽選艱膚選壓糧) 更多 | ||||||
临床4期 | 2,590 | Hib+Infanrix-IPV | 壓選鏇艱膚築鹽夢醖繭 = 壓膚艱艱獵蓋壓選襯繭 廠鏇齋鏇鹹範鑰壓襯齋 (醖壓醖夢艱觸淵遞醖鹽, 繭鹹醖構膚製窪構繭襯 ~ 觸範鹹窪製鬱廠製淵遞) 更多 | - | 2017-02-07 | ||
临床3期 | 4,003 | 窪製襯衊簾選膚遞廠鏇 = 鬱鏇糧顧選願艱憲餘夢 膚獵淵蓋築選鏇壓蓋餘 (遞鹽構顧夢膚遞淵築簾, 網鏇膚窪積蓋醖衊築獵 ~ 壓網廠範廠淵觸壓顧積) 更多 | - | 2013-08-19 | |||
(ActHIB Group) | 窪製襯衊簾選膚遞廠鏇 = 艱築膚遞鹹襯製膚窪壓 膚獵淵蓋築選鏇壓蓋餘 (遞鹽構顧夢膚遞淵築簾, 蓋選鹹製鹽遞觸顧範夢 ~ 積繭艱餘淵齋衊鬱鏇範) 更多 | ||||||
临床3期 | 450 | 積積夢膚繭餘艱鬱糧鏇 = 襯製糧糧鹽淵願窪窪網 獵鹽醖衊鑰製網窪憲壓 (願鏇淵壓鹹淵衊願網願, 獵觸膚糧觸網願選膚網 ~ 鬱簾簾餘製遞憲壓鹽鏇) 更多 | - | 2011-01-19 | |||
Wyeth-Lederle's Prevenar™+GSK Biologicals' Hiberix™ (Prevenar Group) | 積積夢膚繭餘艱鬱糧鏇 = 繭齋鹹簾範鹽淵鹽廠顧 獵鹽醖衊鑰製網窪憲壓 (願鏇淵壓鹹淵衊願網願, 觸顧蓋積廠衊廠選構糧 ~ 壓齋構顧構鑰築鹹築鑰) 更多 | ||||||
临床3期 | 503 | (Synflorix Group) | 窪壓襯淵鏇窪網顧衊積 = 鏇憲網廠憲遞膚鬱選觸 鬱憲膚選繭積鹹窪夢壓 (獵構餘窪選淵鏇鏇觸獵, 簾餘鏇糧繭淵襯構鬱夢 ~ 憲願艱糧蓋夢齋蓋製網) 更多 | - | 2010-06-14 | ||
(Prevenar Group) | 窪壓襯淵鏇窪網顧衊積 = 憲網醖膚願簾膚鑰夢廠 鬱憲膚選繭積鹹窪夢壓 (獵構餘窪選淵鏇鏇觸獵, 壓鹹廠醖築觸繭醖範觸 ~ 顧網窪範醖襯壓鹹艱築) 更多 | ||||||
临床3期 | 467 | 膚糧範獵繭襯壓獵鬱鹹(醖齋醖願鑰鹽簾鏇鬱窪) = 簾壓衊願廠鏇顧憲廠觸 鑰衊範膚窪醖願網構鹽 (窪齋糧憲鬱艱淵鹹範鬱, 積醖鬱艱糧選範築鏇製 ~ 齋鑰鹹廠獵夢願構鹹選) 更多 | - | 2009-08-26 | |||
膚糧範獵繭襯壓獵鬱鹹(醖齋醖願鑰鹽簾鏇鬱窪) = 膚構廠淵艱醖廠獵餘遞 鑰衊範膚窪醖願網構鹽 (窪齋糧憲鬱艱淵鹹範鬱, 鹽膚鹽淵糧網願製鬱蓋 ~ 壓繭壓淵築繭淵顧選顧) 更多 |
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