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, GSK 208108

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Hemophilus influenza infection

Inactive Indication-

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),

Hemophilus influenza infection

Regulation-

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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)

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

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

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159

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: Qin, Wei ; Zhang, Huan ; Tian, Yongjie ; Ma, Liguo ; Zhao, Changjun ; Ma, Bingxin ; 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.

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: Li, Jing ; Zhu, Yiqing ; Wang, Yihan ; Guo, Yu ; Wang, Jinghui ; Wang, Yafei ; 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.

30 Sep 2021·The Journal of infectious diseasesQ2 · MEDICINE

Hib Vaccines: Their Impact on Haemophilus influenzae Type b Disease

Q2 · MEDICINE

Article

Author: Gilsdorf, Janet R

Abstract:

Haemophilus influenzae serotype b (Hib) is an important cause of serious, invasive infections, particularly in young children. Since 1985, a series of vaccines composed of the type b capsular polysaccharide polyribosylribitol phosphate (PRP), followed by PRP conjugated to various proteins, have been licensed for use in the United States and worldwide. The conjugated vaccines offer increased immunogenicity and prolonged durability of immune protection compared to the plain PRP vaccine and increasingly are combined with other childhood vaccines for decreased cost and increased ease of vaccination. Hib vaccines have a very favorable safety profile, have been found to be either cost-saving or cost-effective by many public health agencies, and, in most countries, are initiated during early infancy as part of routine childhood immunization programs. As a result of widespread use of the vaccines, the incidence of Hib infections, and their associated morbidity and mortality, has fallen dramatically across the globe. Yet, many children remain unimmunized or underimmunized against Hib, particularly in limited-resource countries. Future efforts to further reduce the disease burden of Hib infections remain a high priority.

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

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External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemophilus influenza infection	United States	GlaxoSmithKline LLC	19 Aug 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03207750 (CTgov)	Phase 3	Rotavirus Infections \| Viral gastroenteritis due to Rotavirus	1,280	Hiberix+human rotavirus (HRV) vaccine+PCV+Prevnar-13+Pediarix (HRV Porcine Circovirus (PCV)-Free Liquid Group)	fluxgjrcso = bsizwnnbwv erohisjbnj (epacjierjg, cnvxdmjwcz - cftiblejjn) View more	-	31 Oct 2019
				Hiberix+human rotavirus (HRV) vaccine+Prevnar-13+Pediarix (HRV Lyophilized Group)	fluxgjrcso = jprpbzhwiw erohisjbnj (epacjierjg, tczndkkaiy - mlxmbwvbxz) View more
NCT00291343 (CTgov)	Phase 3	Meningococcal Infections	296	Tritanrix-HepB+Mencevax ACWY+Hib-MenAC (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group)	chvhzkztgx = hzphumlkhr bmkqctljbl (ryjdtagjct, qttozfburo - hjsmrafxfz) View more	-	03 Aug 2017
				Tritanrix-HepB+Hiberix+Mencevax ACWY (Tritanrix-HepB/Hiberix+Mencevax ACWY Group)	chvhzkztgx = ywvyasxgvw bmkqctljbl (ryjdtagjct, dcqhyacsou - jiknfvbymy) View more
NCT00317109 (CTgov)	Phase 3	Meningococcal Infections	168	Tritanrix-HepB+Hiberix (Tritanrix-HepB/Hiberix Group)	phtvgcjorh = ekoktvifph vqyqjzwbqm (ujmbnnzwqf, syirmrxpsl - nfutiwbpbr) View more	-	01 Mar 2017
				Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group)	phtvgcjorh = nrckyezwjm vqyqjzwbqm (ujmbnnzwqf, elejfljklw - wwuawvhyqf) View more
NCT00325156 (CTgov)	Phase 4	Hemophilus influenza infection \| Diphtheria \| Whooping Cough ... View more	2,590	Hib+Infanrix-IPV	dachceigok = xrtjpunzwl gzeeynfcra (zbdzdjplqp, wrnognzfaj - owfltvijxd) View more	-	07 Feb 2017
NCT01000974 (CTgov)	Phase 3	Haemophilus Infections	4,003	GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (Hiberix Group)	grnjpxpzct = ypjcmbrugb bneyhcinkl (ebdfpwikfp, roztgcumla - dnzrjtbavd) View more	-	19 Aug 2013
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	grnjpxpzct = tlkaqygqwi bneyhcinkl (ebdfpwikfp, viyhneilhw - vofgfauwhw) View more
NCT00911144 (CTgov)	Phase 3	Streptococcal Infections	450	GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)+GSK Biologicals' Hiberix™ (Synflorix Group)	rriofhophg = imvvneaswl lategidhbo (tbelhmcpeh, cccecoyfwp - nbqssfuars) View more	-	19 Jan 2011
				Wyeth-Lederle's Prevenar™+GSK Biologicals' Hiberix™ (Prevenar Group)	rriofhophg = unskeiubgf lategidhbo (tbelhmcpeh, ldxzkiuhpl - wurusekqnl) View more
NCT00680914 (CTgov)	Phase 3	Streptococcal Infections	503	Pneumococcal vaccine GSK1024850A (Synflorix)+GSK Biologicals' Hiberix™ (Synflorix Group)	wwahgwqhka = smgekgtkdf hnbhmdziep (jykqeotqfy, uwcynmazum - isjxaziddn) View more	-	14 Jun 2010
				GSK Biologicals' Hiberix™+Prevenar (Prevenar Group)	wwahgwqhka = wmmfdpowje hnbhmdziep (jykqeotqfy, akdrifcafw - xlhkgtdobg) View more
NCT00696423 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	467	Hiberix™+Infanrix™ (Infanrix/Hib Single Injection Group)	cocefayxan(wjyfdkhpep) = pdcxqudkty mxympdonva (jvshjfrtyo, uvwkifpsnc - iyngpogszu) View more	-	26 Aug 2009
				Hiberix™+Infanrix™ (Infanrix + Hiberix Separate Injection Group)	cocefayxan(wjyfdkhpep) = ccxqsljpac mxympdonva (jvshjfrtyo, pdhjvgbhvt - mycztljzpm) View more