Delving into the Latest Updates on Haemophilus b conjugate vaccine(GSK Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine

Synonyms

Hib vaccine conjugate(GSK Plc), Hiberix

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Haemophilus Infections

Inactive Indication

DiphtheriaHepatitis BPoliomyelitis+ [6]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline LLC

Inactive Organization

GSK Plc

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (19 Aug 2009),

Haemophilus Infections

Regulation-

Login to view timeline

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.

Start Date19 Jun 2019

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03620162

/ CompletedPhase 3

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)

The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.

Start Date18 Oct 2018

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03621670

/ CompletedPhase 3

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccines(RIV).

Start Date27 Jul 2018

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Haemophilus b conjugate vaccine(GSK Plc)

Login to view more data

100 Translational Medicine associated with Haemophilus b conjugate vaccine(GSK Plc)

Login to view more data

100 Patents (Medical) associated with Haemophilus b conjugate vaccine(GSK Plc)

Login to view more data

202

Literatures (Medical) associated with Haemophilus b conjugate vaccine(GSK Plc)

31 Jan 2025·Open 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

Author: Liu, Yongyu ; Pan, Fan ; Qin, Wei ; Ma, Liguo ; Zhao, Changjun ; Chen, Yafei ; Ma, Bingxin ; Tian, Yongjie ; Zhang, Huan ; Zhou, Yu ; Wang, Yao

AbstractBackgroundThe 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.MethodsWe 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.ResultsA 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.ConclusionsAll 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.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Adverse events following immunization of co- and separate administration of DTaP-IPV/Hib vaccines: A real-world comparative study

Article

Author: Wang, Jinghui ; Zhu, Yiqing ; Guo, Yu ; Li, Jing ; Wang, Yihan ; Sun, Li ; Wang, Lina ; Wang, Yafei

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.

01 Dec 2024·International Journal of Infectious Diseases

Estimating the global and regional burden of lower respiratory infections attributable to leading pathogens and the protective effectiveness of immunization programs

Article

Author: Sun, Lin ; Yu, Xiaoran ; Zou, Zhiyong ; Chen, Wanning ; Ma, Sheng ; Wang, Huan

OBJECTIVESReducing mortality from infectious diseases is an urgent global public health priority. Streptococcus pneumoniae, H. influenzae, and influenza virus are the three leading causes of lower respiratory infections (LRIs) death worldwide. Our objective was to assess the global burden of LRIs attributable to S. pneumoniae, H. influenzae, and influenza virus and explore the protective effectiveness of immunization programs.METHODSData were retrieved from the Global Burden of Disease Study 2021 and World Health Organization United Nations Children's Fund Estimates of National Immunization Coverage. Locally weighted linear regression and Spearman correlation analysis were used to examine the associations between LRI mortality and vaccination coverage. Mixed-effects regression models were used to estimate the reduction in deaths that would be reduced by pneumococcal conjugate vaccine (PCV) and the H. influenzae type b (Hib) vaccine if all countries realized the Immunization Agenda 2030 (IA2030).RESULTSIn 2021, about 30.2% of the 2.18 million LRI-related deaths were attributed to three studied pathogens. From 1990 to 2021, the age-standardized mortality rate of LRIs was attributable to three pathogens decreased by more than half. In 2022, the global vaccination rates for PCV and Hib vaccines were 60.0% and 76.0%, respectively. The LRIs attributable to S. pneumoniae (r_s = -0.45, P <0.001) and H. influenzae (r_s = -0.47, P <0.001) decreased with the increasing vaccination coverage of PCV and Hib. By 2030, approximately 59.9% and 70.8% of countries worldwide will reach the IA2030 targets of 90% coverage for PCV and Hib, respectively. By that time, the number of deaths from LRIs in children attributable to S. pneumoniae and H. influenzae will decrease by 54.8% and 24.4%, respectively.CONCLUSIONSDespite the declines in LRI mortality attributed to respiratory pathogens, substantial deaths still occurred in 2021. To advance toward achieving the IA2030 targets and further mitigate mortality associated with LRIs, intensified efforts by the international community and national health systems are imperative.

100 Deals associated with Haemophilus b conjugate vaccine(GSK Plc)

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07AG51	-

R&D Status

Approved

10 top approved records.

Login

to view more data

Indication	Country/Location	Organization	Date
Haemophilus Infections	United States	GlaxoSmithKline LLC	19 Aug 2009

Developing

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Rotavirus Infections	Phase 2	United States	GSK Plc	14 Sep 2017
Viral gastroenteritis due to Rotavirus	Phase 2	United States	GSK Plc	14 Sep 2017
Tuberculosis	Phase 2	Gambia	GSK Plc	07 Jul 2010
Streptococcal Infections	Phase 2	United States	GSK Plc	10 Jun 2008
Diphtheria	Phase 2	-	GSK Plc	01 Sep 2000
Hepatitis B	Phase 2	-	GSK Plc	01 Sep 2000
Poliomyelitis	Phase 2	-	GSK Plc	01 Sep 2000
Tetanus	Phase 2	-	GSK Plc	01 Sep 2000
Whooping Cough	Phase 2	-	GSK Plc	01 Sep 2000

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03893448 (PNEU-PED \| V114-029, CTgov)	Phase 3	Pneumococcal Infections \| Pneumonia \| Dystonia 18	1,720	HIBERIX™+Pentacel™+Varivax™+RECOMBIVAX HB™+VAQTA™+RotaTeq™+V114+MMR II™ (V114)	wyhqjtxhyn(jvxtoghvzw) = mcshbplwvy ywfemvsohh (hshygigjid, hpyvlhrquo - ejwfaaroun) View more	-	25 Mar 2022
				HIBERIX™+Pentacel™+Varivax™+RECOMBIVAX HB™+VAQTA™+RotaTeq™+Prevnar 13™+MMR II™ (Prevnar 13™)	wyhqjtxhyn(jvxtoghvzw) = gznrxjnwof ywfemvsohh (hshygigjid, raiwauuaio - xtrapjhnft) View more
NCT03620162 (V114-027, CTgov)	Phase 3	Pneumococcal Infections	900	HIBERIX™+Pentacel™+VARIVAX™+RECOMBIVAX HB™+RotaTeq™+Prevnar 13™+M-M-R™ II (Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™)	wvvepjvfue(nzbawpfnwp) = hqygrbqrbg ziakcmkpyp (ajiokslkhp, wxyzjkfdce - zawkbpqfaq) View more	-	23 Aug 2021
				HIBERIX™+Pentacel™+VARIVAX™+RECOMBIVAX HB™+RotaTeq™+Prevnar 13™+V114+M-M-R™ II (Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114)	wvvepjvfue(nzbawpfnwp) = bbzwomsiwd ziakcmkpyp (ajiokslkhp, fjiftjbdkm - hcolulxgzr) View more
NCT03207750 (CTgov)	Phase 3	Rotavirus Infections \| Viral gastroenteritis due to Rotavirus	1,280	PCV+Hiberix+human rotavirus (HRV) vaccine+Prevnar-13+Pediarix (HRV Porcine Circovirus (PCV)-Free Liquid Group)	qrejmdxrdx(zzmrpanxiw) = myjifozmks qzmvkkivvh (puhhpnpqco, phahxoqafm - juficqrgsl) View more	-	31 Oct 2019
				Hiberix+human rotavirus (HRV) vaccine+Prevnar-13+Pediarix (HRV Lyophilized Group)	qrejmdxrdx(zzmrpanxiw) = rayhndqdjl qzmvkkivvh (puhhpnpqco, rxhcbydhra - cehrffkbvv) View more
NCT00547248 (CTgov)	Phase 3	Streptococcal Infections	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	(uobnjgxhng) = aiagqxlzgr qkavblqyhj (rtvlsbbgly, zkmkcmxtay - mavzsiehpm) View more	-	14 Jan 2019
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(uobnjgxhng) = jwfrdalobl qkavblqyhj (rtvlsbbgly, fxphwcvzzr - ubzmplqidi) View more
NCT01098474 (CTgov)	Phase 2	Tuberculosis	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	ucvawrypsn(qmsmvapnvf) = roitrvrxet fjmqwcgbfa (rinepausol, vugupmncww - nqltcuepon) View more	-	27 Nov 2018
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	ucvawrypsn(qmsmvapnvf) = cspwywamme fjmqwcgbfa (rinepausol, redakxmxpq - ntwfyhdgsn) View more
NCT02096263 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	585	Hiberix+Infanrix+Infanrix hexa+Rotarix+Prevnar13 (Infanrix Hexa Group)	cravdatbfs(turntksyva) = vlmgcrdekv mbquqmxtfx (rujzyifeoi, yqbxbdqluq - ergbteinco) View more	-	01 Aug 2018
				ActHIB+Infanrix+Rotarix+Prevnar13+Pediarix (Pediarix Group)	cravdatbfs(turntksyva) = vdjsxbmibv mbquqmxtfx (rujzyifeoi, hkmhrysaoy - itqmhrzdgj) View more
NCT00291343 (CTgov)	Phase 3	Meningococcal Infections	296	Tritanrix-HepB+Mencevax ACWY+Hib-MenAC (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group)	zapqpwhfdc(sbdsitqyxr) = lpqsqptczl zeqacpwwqm (esgluuudeq, yzajwdkabh - kvrwrnmxix) View more	-	03 Aug 2017
				Tritanrix-HepB+Hiberix+Mencevax ACWY (Tritanrix-HepB/Hiberix+Mencevax ACWY Group)	zapqpwhfdc(sbdsitqyxr) = tvljicrvgz zeqacpwwqm (esgluuudeq, wlumiorwdb - xsjruizgrp) View more
NCT00317109 (CTgov)	Phase 3	Meningococcal Infections	168	Tritanrix-HepB+Hiberix (Tritanrix-HepB/Hiberix Group)	bzqucjdgpp(applxvnulc) = iqtpqewfes dlzkaxmmmn (tzjbmyepio, wgcvodljxf - niteavezep) View more	-	01 Mar 2017
				Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group)	bzqucjdgpp(applxvnulc) = kvyzhpfguc dlzkaxmmmn (tzjbmyepio, tkpzzldqzw - zaapjzfxwm) View more
NCT00169442 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus	745	Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB Kft (PRP Tritanrix-HepB Kft. Mix Group)	xxkgfsvuwf(uuucikkbux) = hnkydhgqca zainimbrum (ueqvpfvgxk, sxbkydismi - tcdoauzwip) View more	-	28 Feb 2017
				Polyribosil-Ribitol-Phosphate (PRP) vaccine+Tritanrix™-HepB Kft (PRP Tritanrix-HepB Kft. Ref Group)	xxkgfsvuwf(uuucikkbux) = swcnstbetv zainimbrum (ueqvpfvgxk, eqfsabjlgi - ucxghgreqf) View more
NCT01000974 (CTgov)	Phase 3	Haemophilus Infections	4,003	GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (Hiberix Group)	sdptobkipn(jrbexfxock) = gpkysiiqoi auoanxkmew (esuvkkplpt, baltnunhgm - ztunoywoxl) View more	-	19 Aug 2013
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	sdptobkipn(jrbexfxock) = hqvsrnrgvf auoanxkmew (esuvkkplpt, qsminoiybb - yonurimdlk) View more