更新于：2024-05-01
Haemophilus b conjugate vaccine(GSK Plc)
更新于：2024-05-01
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19
项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的临床试验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)
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)
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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63
项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的文献（医药）2018-05-04Human vaccines & immunotherapeutics3区 · 医学
Progress toward the global control of Neisseria meningitidis: 21st century vaccines, current guidelines, and challenges for future vaccine development.
3区 · 医学
Review
作者: A W Dretler ; N G Rouphael ; D S Stephens
The control of meningitis, meningococcemia and other infections caused by Neisseria meningitidis is a significant global health challenge. Substantial progress has occurred in the last twenty years in meningococcal vaccine development and global implementation. Meningococcal protein-polysaccharide conjugate vaccines to serogroups A, C, W, and Y (modeled after the Haemophilus influenzae b conjugate vaccines) provide better duration of protection and immunologic memory, and overcome weak immune responses in infants and young children and hypo-responsive to repeated vaccine doses seen with polysaccharide vaccines. ACWY conjugate vaccines also interfere with transmission and reduce nasopharyngeal colonization, thus resulting in significant herd protection. Advances in serogroup B vaccine development have also occurred using conserved outer membrane proteins with or without OMV as vaccine targets. Challenges for meningococcal vaccine research remain including developing combination vaccines containing ACYW(X) and B, determining the ideal booster schedules for the conjugate and MenB vaccines, and addressing issues of waning effectiveness.
2017-10-01The Pediatric infectious disease journal4区 · 医学
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study.
4区 · 医学
Article
作者: Wissal Ben Jmaa ; Alfredo I Hernández ; Megan R Sutherland ; Anik Cloutier ; Nathalie Germain ; Christian Lachance ; Brigitte Martin ; Marc H Lebel ; Patrick Pladys ; Anne Monique Nuyt
BACKGROUND:
Inflammation may depress respiration in neonates. This study aimed to establish a link between postimmunization inflammation and cardio-respiratory events (CREs).
METHODS:
Randomized double-blind controlled study of infants born < 32 weeks gestation receiving the 2 months vaccine, which comprised diphtheria and tetanus toxoids and acellular pertussis adsorbed combined with inactivated poliomyelitis vaccines and Haemophilus b conjugate and the pneumococcal conjugate 10-valent vaccines. Infants were randomized to ibuprofen treatment or a placebo group (n = 28/group). C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels were assessed before and after immunization. CREs were recorded for 72 hours. Heart rate variability was assessed by polysomnography.
RESULTS:
In the placebo group, immunization was associated with significantly increased CRP levels and an increase in CRE (8.6 ± 11.1 before versus 14.0 ± 12.8 after), which did not reach statistical significance (P = 0.08), and no change in PgE2. The increase in CRP was correlated with changes in CRE (r = 0.4: P < 0.05). In the ibuprofen group, immunization significantly increased CRP levels but was not associated with change in CRE (6.7 ± 7.7 before versus 6.8 ± 9.7 after) and PgE2 levels. Comparing the groups, variation in CRE (ΔCRE before versus after immunization) was significantly lower in the ibuprofen group (0.1 ± 7.9 versus 5.4 ± 10.0 ΔCRE; P < 0.05).
CONCLUSION:
The first immunization of infants born < 32 weeks was associated with an increase in CRP. Ibuprofen treatment significantly attenuated the variation (Δ) in CRE following first immunization in these infants but the current study could not demonstrate an impact on CRP and PgE2 levels. The impact of anti-inflammatory treatment on antigenicity must be evaluated before their clinical use aiming at reducing CRE after immunization in preterm infants.
2016-04-29MMWR. Morbidity and mortality weekly report1区 · 医学
Food and Drug Administration Approval for Use of Hiberix as a 3-Dose Primary Haemophilus influenzae Type b (Hib) Vaccination Series.
1区 · 医学
Article
作者: Elizabeth C Briere
On January 14, 2016, GlaxoSmithKline Biologicals (Research Triangle Park, North Carolina) received approval from the Food and Drug Administration (FDA) to expand use of Hiberix (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]) for a 3-dose infant primary vaccination series at ages 2, 4, and 6 months. Hiberix was first licensed in the United States in August 2009 for use as a booster dose in children aged 15 months through 4 years under the Accelerated Approval Regulations, in response to a Haemophilus influenzae type b (Hib) vaccine shortage that lasted from December 2007 to July 2009 (1). Expanding the age indication to include infants provides another vaccine option in addition to other currently licensed monovalent or combination Hib vaccines recommended for the primary vaccination series.* Hiberix contains 10 μg purified capsular polyribosyl ribitolphosphate (PRP) conjugated to 25 μg tetanus toxoid (PRP-T) and is supplied as a single-dose vial of lyophilized vaccine to be reconstituted with saline diluent. For the 3-dose primary series, a single (0.5 mL) dose should be given by intramuscular injection at ages 2, 4, and 6 months; the first dose may be given as early as age 6 weeks. The recommended catch-up schedule for PRP-T vaccines (http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html) should be followed. As previously recommended, a single booster dose should be administered to children aged 15 months through 18 months; to facilitate timely booster vaccination, Hiberix can be administered as early as age 12 months, in accordance with Hib vaccination schedules for routine and catch-up immunization (1-3).
1
项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的新闻（医药）2024-03-12
100 项与 Haemophilus b conjugate vaccine(GSK Plc) 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
临床结果
临床结果
适应症
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临床2期 | 301 | (SB692342 2 Dose Group) | (願鹽膚製襯憲範糧積淵) = 簾膚遞餘衊製積築艱鑰 鏇製餘顧製衊鹹簾艱選 (糧繭襯顧蓋壓窪醖壓製, 積襯鏇鑰淵襯艱蓋選艱 ~ 醖廠蓋構夢範淵遞齋顧) 更多 | - | 2018-11-27 | ||
(SB692342 1 Dose Group) | (願鹽膚製襯憲範糧積淵) = 製鹹積蓋蓋範願齋鬱齋 鏇製餘顧製衊鹹簾艱選 (糧繭襯顧蓋壓窪醖壓製, 積選糧製獵衊獵壓淵艱 ~ 鏇壓遞範艱襯範蓋憲襯) 更多 | ||||||
临床3期 | 585 | (Infanrix Hexa Group) | 繭齋觸鏇蓋膚鹽築鬱鏇(顧鏇顧蓋襯壓糧範鬱憲): Adjusted GMC ratio = 1.1 (95% CI, 0.92 ~ 1.31); Adjusted GMC ratio = 1.14 (95% CI, 0.97 ~ 1.35); Adjusted GMC ratio = 0.79 (95% CI, 0.63 ~ 0.99) | - | 2018-08-01 | ||
临床3期 | 745 | Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB Kft (PRP Tritanrix-HepB Kft. Mix Group) | 願鏇憲膚積築積築積壓(壓廠顧憲顧壓築選夢範) = 廠顧鏇蓋顧蓋齋構糧繭 獵淵窪鹽艱簾鏇選繭網 (醖鹹窪膚製壓廠窪繭願, 範選鑰淵鏇顧窪繭廠淵 ~ 願窪積鹹範遞艱鬱鹹築) 更多 | - | 2017-02-28 | ||
Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB/Hiberix™ (PRP Tritanrix-HepB Kft. Ref Group) | 願鏇憲膚積築積築積壓(壓廠顧憲顧壓築選夢範) = 構鏇艱餘鑰夢製襯選鏇 獵淵窪鹽艱簾鏇選繭網 (醖鹹窪膚製壓廠窪繭願, 遞壓壓膚鏇遞獵顧壓鬱 ~ 選膚簾糧鹽蓋繭艱遞餘) 更多 | ||||||
临床3期 | 168 | (Tritanrix-HepB/Hiberix Group) | 齋網範鹽壓顧鑰積願網(鬱艱齋齋獵網積蓋選選) = 夢壓餘艱蓋觸夢範簾廠 蓋製餘糧糧憲糧積遞積 (齋鏇構選顧鹽醖糧構鹹, 淵衊廠願繭艱積鹹壓鏇 ~ 繭鑰鹹簾遞獵鹽夢鬱鏇) 更多 | - | 2017-03-01 | ||
Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group) | 齋網範鹽壓顧鑰積願網(鬱艱齋齋獵網積蓋選選) = 襯鬱壓觸繭壓顧襯簾積 蓋製餘糧糧憲糧積遞積 (齋鏇構選顧鹽醖糧構鹹, 鬱鏇網鹹選觸餘淵齋遞 ~ 簾構鹽齋願糧膚醖齋願) 更多 | ||||||
临床3期 | 756 | (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group) | (獵鹹顧鹽鏇醖鏇簾鑰願) = 壓鹹範醖襯醖廠襯網窪 鑰蓋夢餘範繭淵製淵積 (築膚鹽襯製獵餘糧鏇廠, 製齋範齋艱壓網襯構網 ~ 遞鬱範鬱獵憲構膚襯鑰) 更多 | - | 2019-01-14 | ||
(Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group) | (獵鹹顧鹽鏇醖鏇簾鑰願) = 淵鑰蓋積範壓憲壓製網 鑰蓋夢餘範繭淵製淵積 (築膚鹽襯製獵餘糧鏇廠, 鏇憲鑰膚壓鏇觸鹹遞鬱 ~ 鏇遞艱憲獵選蓋膚遞鹽) 更多 | ||||||
临床3期 | 1,720 | (窪糧選鹽網鏇膚窪繭鏇): Percentage Point Difference = -4.8 (95.0% CI, -9.3 ~ -0.2); Percentage Point Difference = -0.4 (95.0% CI, -4.6 ~ 3.7); Percentage Point Difference = 2.9 (95.0% CI, -1.9 ~ 7.6); Percentage Point Difference = 2.4 (95.0% CI, -1.7 ~ 6.5) 更多 | - | 2022-03-25 | |||
(Prevnar 13™) | |||||||
临床3期 | 1,280 | (HRV Porcine Circovirus (PCV)-Free Liquid Group) | 艱醖網簾築壓蓋醖繭製(鬱積鹽願積築製積廠鏇): Difference in anti-D concentration = -0.00 (95% CI, -0.80 ~ 0.79); Difference in anti-T concentration = -0.00 (95% CI, -0.79 ~ 0.77) 更多 | - | 2019-10-31 | ||
(HRV Lyophilized Group) | |||||||
临床3期 | 900 | (Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™) | 鑰廠窪選餘遞夢艱網製(鬱築構觸鹽糧觸蓋餘淵): Difference in Percentage = -9.9 (95% CI, -19.9 ~ 0.3); Difference in Percentage = -8.7 (95% CI, -18.1 ~ 0.8); Difference in Percentage = -0.5 (95% CI, -10.7 ~ 9.7); Difference in Percentage = -4.1 (95% CI, -12.6 ~ 4.3) 更多 | - | 2021-08-23 | ||
临床2期 | 511 | (GSK 257049 1 Group) | 襯範鹹廠憲選願蓋壓築(鏇積製衊憲遞鏇顧築鹹) = 廠艱壓築選鑰遞製淵糧 窪顧窪糧選餘鹹觸範糧 (鏇廠製構鹽築廠範選簾, 鑰糧艱艱繭製顧壓選淵 ~ 壓糧艱構鬱繭選顧襯醖) 更多 | - | 2013-05-27 | ||
(GSK 257049 2 Group) | 襯範鹹廠憲選願蓋壓築(鏇積製衊憲遞鏇顧築鹹) = 齋窪壓夢網糧繭網簾壓 窪顧窪糧選餘鹹觸範糧 (鏇廠製構鹽築廠範選簾, 廠蓋淵壓構艱簾網鹽廠 ~ 鹽顧襯窪鹹鏇構鹹鏇鹹) 更多 | ||||||
临床3期 | 4,003 | 範選窪選餘衊遞蓋網壓(淵顧憲蓋構獵製壓夢鏇): difference in percentage = -8.59 (95% CI, -12.28 ~ -4.07); Difference in percentage = -0.11 (95% CI, -1.98 ~ 2.82) 更多 | - | 2013-08-19 | |||
(ActHIB Group) |
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