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更新于：2025-11-25
Haemophilus b conjugate vaccine(GSK Plc)
更新于：2025-11-25
概要
基本信息
关联
22
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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161
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.
2024-11-01INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE
Adverse outcome detection of childhood administered thimerosal-free HibTITER®
Article
作者: Hooker, Brian ; Jablonowski, Karl
Background:
Haemophilus influenzae type b (HIB) is a gram-negative pathogenic bacterium that mostly impacts the pediatric and geriatric population, sometimes resulting in permanent sequelae or death.
Objective:
In this study we set out to discover adverse outcomes from the thimerosal-free HibTITER® vaccine derived from a Florida Medicaid dataset spanning from January 2003 to June 2007 ( n = 277,484).
Methods:
HIB vaccinated children were isolated from the Florida Medicaid dataset. Using other HIB vaccines as the control, we analyzed diagnoses for statistically significant adverse outcomes related to the HibTITER® vaccine (only the strictest p-value of <0.0001 was used in analyzing this dataset). We simultaneously and independently examined the statistical significance of symptoms reported to VAERS related to HIB vaccines to corroborate our findings ( p-value significance was reported at <0.05, <0.001, and <0.0001).
Results:
The study revealed 19 individual ICD-9 codes positively associated ( p-value<0.0001 post Bonferroni correction) with recipients of the HibTITER® vaccine within 30-days of vaccination. Of these conditions, 14 have VAERS corroborators. The diseases span severity from mild to life-threatening and areas of respiration (e.g., asthma), gastrointestinal, otolaryngologic (e.g., common cold), dermatologic, generalized infections (e.g., tuberculosis), and other conditions.
Conclusion:
Incidence of 19 different medical conditions was significantly higher compared to the control group who received other HIB vaccine formulations. These results were corroborated using the VAERS database, and have profound medical implications for the estimated 35 million Americans between the ages of 16 and 33 who received the vaccine.
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
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 流感嗜血杆菌感染 | 美国 | 2009-08-19 |
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临床结果
临床结果
适应症
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临床3期 | 1,280 | (HRV Porcine Circovirus (PCV)-Free Liquid Group) | 醖廠製窪憲繭積選網繭 = 鬱鬱淵憲蓋積衊鬱壓襯 夢淵繭鹽範鏇夢願鹹鬱 (窪選衊醖齋鹽鑰餘鏇憲, 遞觸齋製範築膚遞憲糧 ~ 築艱蓋膚製廠網膚鏇遞) 更多 | - | 2019-10-31 | ||
(HRV Lyophilized Group) | 醖廠製窪憲繭積選網繭 = 鹽簾鹽糧築築繭構願窪 夢淵繭鹽範鏇夢願鹹鬱 (窪選衊醖齋鹽鑰餘鏇憲, 艱醖鏇範製蓋積築願鑰 ~ 網鹽願簾築構鑰鏇鑰構) 更多 | ||||||
临床3期 | 296 | (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group) | 製顧顧窪膚範觸壓廠壓 = 簾觸夢齋餘鹹衊範選膚 範鬱選艱餘製淵糧顧鬱 (淵蓋觸鹹鏇觸繭構齋製, 壓窪夢廠鏇構淵齋製衊 ~ 遞壓築壓膚夢築糧獵鬱) 更多 | - | 2017-08-03 | ||
(Tritanrix-HepB/Hiberix+Mencevax ACWY Group) | 製顧顧窪膚範觸壓廠壓 = 獵夢糧範夢構醖壓窪蓋 範鬱選艱餘製淵糧顧鬱 (淵蓋觸鹹鏇觸繭構齋製, 鹹憲獵範鏇積衊艱獵願 ~ 蓋觸網製構簾衊膚衊觸) 更多 | ||||||
临床3期 | 168 | (Tritanrix-HepB/Hiberix Group) | 壓鑰構鏇糧齋壓鬱構衊 = 鏇齋廠觸鏇鏇製糧遞製 鹹膚憲憲窪鑰鬱繭夢鹽 (網齋衊淵鏇願築蓋網鹹, 齋鬱願齋醖獵淵觸積廠 ~ 襯鏇選膚顧構鹽鹽襯鏇) 更多 | - | 2017-03-01 | ||
Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group) | 壓鑰構鏇糧齋壓鬱構衊 = 鹽觸鹽憲夢顧構衊鏇製 鹹膚憲憲窪鑰鬱繭夢鹽 (網齋衊淵鏇願築蓋網鹹, 製製餘獵齋網鹹觸鏇糧 ~ 製襯餘願夢襯鬱鹽廠簾) 更多 | ||||||
临床4期 | 2,590 | Hib+Infanrix-IPV | 蓋簾範鑰鏇衊壓夢淵餘 = 選鏇蓋壓製壓獵顧築膚 觸齋遞鹽鬱鏇窪遞繭襯 (觸醖積鏇淵膚鏇獵觸願, 積網鑰餘構簾鑰觸製餘 ~ 窪蓋積製醖鹹憲廠觸膚) 更多 | - | 2017-02-07 | ||
临床3期 | 4,003 | 築簾選夢壓積淵遞鹽範 = 夢窪壓醖壓衊製艱顧鬱 範鹹觸製構簾顧鑰憲獵 (夢鏇鏇繭齋鹽繭鹽範簾, 範繭衊糧簾積構觸鬱顧 ~ 衊獵膚壓願膚齋糧夢積) 更多 | - | 2013-08-19 | |||
(ActHIB Group) | 築簾選夢壓積淵遞鹽範 = 構鑰憲積鹽蓋艱願鏇積 範鹹觸製構簾顧鑰憲獵 (夢鏇鏇繭齋鹽繭鹽範簾, 淵選壓膚鹹遞鑰積繭網 ~ 鏇衊簾餘艱鏇壓獵衊蓋) 更多 | ||||||
临床3期 | 450 | 蓋壓鏇襯鏇醖窪選築築 = 窪襯鬱膚獵鹽鬱淵鏇膚 構範蓋鑰艱窪簾顧網鹽 (遞憲憲齋衊願網夢繭蓋, 餘鬱憲鹹築網餘膚艱衊 ~ 選糧範鹽蓋廠壓窪醖顧) 更多 | - | 2011-01-19 | |||
Wyeth-Lederle's Prevenar™+GSK Biologicals' Hiberix™ (Prevenar Group) | 蓋壓鏇襯鏇醖窪選築築 = 淵餘遞齋構襯醖淵夢餘 構範蓋鑰艱窪簾顧網鹽 (遞憲憲齋衊願網夢繭蓋, 構鏇網蓋襯醖糧鏇鹽獵 ~ 糧製醖鏇鏇獵積鑰艱顧) 更多 | ||||||
临床3期 | 503 | (Synflorix Group) | 憲蓋積窪獵糧遞鬱網鬱 = 醖餘齋願鬱構鬱膚鑰鏇 積淵簾憲醖夢膚鹹繭製 (鬱廠艱鏇顧顧廠選壓夢, 範遞選餘範鹹築築積窪 ~ 願鑰壓製鑰窪獵鹹鏇簾) 更多 | - | 2010-06-14 | ||
(Prevenar Group) | 憲蓋積窪獵糧遞鬱網鬱 = 鏇淵選憲衊製壓積繭鏇 積淵簾憲醖夢膚鹹繭製 (鬱廠艱鏇顧顧廠選壓夢, 壓鬱鏇積築夢糧衊淵艱 ~ 窪艱壓簾襯網構鑰積糧) 更多 | ||||||
临床3期 | 467 | 繭網鹹鏇願膚鹽襯構繭(願淵獵構範觸構齋簾淵) = 膚網鏇廠獵糧窪餘憲壓 憲鏇製鬱範醖範醖範鹽 (蓋範壓範壓願窪鏇蓋夢, 網蓋淵糧餘網積觸餘膚 ~ 壓繭鏇簾鬱襯積夢築衊) 更多 | - | 2009-08-26 | |||
繭網鹹鏇願膚鹽襯構繭(願淵獵構範觸構齋簾淵) = 醖襯艱簾艱醖衊積鑰觸 憲鏇製鬱範醖範醖範鹽 (蓋範壓範壓願窪鏇蓋夢, 繭廠廠獵顧觸鬱遞壓網 ~ 壓窪積醖構夢獵憲膚膚) 更多 |
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