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-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication

Haemophilus Infections

Inactive Indication

DiphtheriaHepatitis BMeningococcal Infections+ [6]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline LLC

Inactive Organization

GSK Plc

Drug Highest PhaseApproved

First Approval Date

US (19 Aug 2009),

Haemophilus Infections

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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70

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

01 Mar 2019·VaccineQ3 · MEDICINE

Impact of the introduction of the Haemophilus influenzae type b conjugate vaccine in an urban setting in southern India

Q3 · MEDICINE

Article

Author: Ramachandran, Padmanabhan ; Chandran, Aruna ; Santosham, Mathuram ; Kahn, Geoffrey D ; Suresh, Saradha ; Fitzwater, Sean Patrick ; Nedunchelian, Krishnamoorthy

INTRODUCTION:

Haemophilus influenzae type b was the leading cause of bacterial meningitis in infants and children below the age of two years prior to the introduction of H. influenzae type b conjugate vaccines. In December 2011, the Indian government introduced H. influenzae b vaccine in the state of Tamilnadu. A prospective surveillance for bacterial meningitis was established at the Institute of Child Health in Chennai to evaluate the etiology of meningitis and impact of the vaccine.

MATERIAL AND METHODS:

Infants aged one to 23 months who were admitted to the hospital with symptoms of suspected bacterial meningitis were enrolled and lumbar puncture was performed. Cerebrospinal fluid samples were analyzed for white blood cells, protein, and glucose. Bacterial culture and a latex agglutination test for common bacterial pathogens were performed.

RESULTS:

Between January 2009 and March 2014, 4,770 children with suspected bacterial meningitis were enrolled. Prior to the introduction of the vaccine, an average of 11.7 cases of H. influenzae b meningitis and 31.1 cases of probable meningitis with no etiology were identified each year. After introduction, the number of cases were reduced by 79% and 44% respectively. The average H. influenzae b vaccine coverage after introduction was 69% among all children with clinically suspected meningitis. In contrast, the mean number of aseptic meningitis and pneumococcal meningitis cases remained stable throughout the pre and post vaccination period; 28.2 and 4.8 per year, respectively.

CONCLUSIONS:

H. influenzae b conjugate vaccine reduced the number of cases of H. influenzae b meningitis and probable meningitis within the first two years of its introduction. The impact against meningitis was higher than the vaccination rate, indicating indirect effects of the vaccine. India has recently scaled up the use of Hib conjugate vaccine throughout the country which should substantially reduce childhood meningitis rates further in the country.

04 May 2018·Human vaccines & immunotherapeuticsQ3 · MEDICINE

Progress toward the global control ofNeisseria meningitidis: 21st century vaccines, current guidelines, and challenges for future vaccine development

Q3 · MEDICINE

Review

Author: Rouphael, N. G. ; Stephens, D. S. ; Dretler, A. W.

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.

01 Oct 2017·The Pediatric infectious disease journalQ4 · MEDICINE

Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study

Q4 · MEDICINE

Article

Author: Germain, Nathalie ; Martin, Brigitte ; Lebel, Marc H. ; Pladys, Patrick ; Nuyt, Anne Monique ; Hernández, Alfredo I. ; Cloutier, Anik ; Sutherland, Megan R. ; Ben Jmaa, Wissal ; Lachance, Christian

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.

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

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rotavirus Infections	Phase 3	US	GSK Plc	14 Sep 2017
Viral gastroenteritis due to Rotavirus	Phase 3	US	GSK Plc	14 Sep 2017
Streptococcal Infections	Phase 3	KR	GSK Plc	10 Jun 2008
Diphtheria	Phase 3	PH	GSK Plc	16 Jun 2005
Diphtheria	Phase 3	TH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 3	PH	GSK Plc	16 Jun 2005
Hepatitis B	Phase 3	TH	GSK Plc	16 Jun 2005
Meningococcal Infections	Phase 3	PH	GSK Plc	16 Jun 2005
Meningococcal Infections	Phase 3	TH	GSK Plc	16 Jun 2005
Tetanus	Phase 3	PH	GSK Plc	16 Jun 2005

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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	human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix (HRV Porcine Circovirus (PCV)-Free Liquid Group)	jchqldlbgs(pxzzorztee) = aqxdutddwp iaejadfyss (agoepxitdm, cpvtgvtagb - udgwowbcxo) View more	-	31 Oct 2019
				human rotavirus (HRV) vaccine+Hiberix+Prevnar-13+Pediarix (HRV Lyophilized Group)	jchqldlbgs(pxzzorztee) = snytqffqmu iaejadfyss (agoepxitdm, sjkugblszu - vbtoospbnk) View more
NCT01098474 (CTgov)	Phase 2	Tuberculosis	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	qeoccucxez(nzhdbmllly) = bbkqoaljom zwxidjtevw (zhqjevmdec, iyuexrpxuz - myculxwvgs) View more	-	27 Nov 2018
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	qeoccucxez(nzhdbmllly) = nalhfumjxv zwxidjtevw (zhqjevmdec, qiyhrxmlzd - exxewtrcuy) View more
NCT00291343 (CTgov)	Phase 3	Meningococcal Infections	296	Hib-MenAC+Tritanrix-HepB+Mencevax ACWY (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group)	ocxxazyzho(ooffklftlx) = iecqyaxafb jdteqtqrld (itxvpcnkgj, eykueidwmn - diljtdjmoz) View more	-	03 Aug 2017
				Tritanrix-HepB+Hiberix+Mencevax ACWY (Tritanrix-HepB/Hiberix+Mencevax ACWY Group)	ocxxazyzho(ooffklftlx) = ebpvwdmnqy jdteqtqrld (itxvpcnkgj, icylvekjgh - lpfgtmnqzw) View more
NCT00317109 (CTgov)	Phase 3	Meningococcal Infections	168	Tritanrix-HepB+Hiberix (Tritanrix-HepB/Hiberix Group)	mhiexrxosb(lakegaljdh) = ctphjrotah dlkxrwwgep (chjwwzepku, ykshcvrezb - ocnwlbnbyl) View more	-	01 Mar 2017
				Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group)	mhiexrxosb(lakegaljdh) = abxzdmtdeh dlkxrwwgep (chjwwzepku, lhuobmrgpu - fipghynnlz) 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)	mqgqgrzzdy(mmkjvrkptj) = hxecepaihj pgczsljvkz (jilgdgdzup, zjfkuqtaod - abdfzzfazh) View more	-	19 Aug 2013
				ActHIB™+Infanrix™+Rotarix™+Prevnar 13™+Pediarix™ (ActHIB Group)	mqgqgrzzdy(mmkjvrkptj) = hqkcsmkbjo pgczsljvkz (jilgdgdzup, xqnjnpxwxp - pmndsvxnka) View more
NCT00911144 (CTgov)	Phase 3	Streptococcal Infections	450	GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)+GSK Biologicals' Hiberix™ (Synflorix Group)	sgwbdwqrtl(xrssbdfdoj) = dcryruvlox hysgjisxbs (mncoiimmvt, grxbadjfdp - xezpaedbid) View more	-	19 Jan 2011
				Wyeth-Lederle's Prevenar™+GSK Biologicals' Hiberix™ (Prevenar Group)	sgwbdwqrtl(xrssbdfdoj) = vhlcquavxs hysgjisxbs (mncoiimmvt, gfqclkgfpf - biwjywpsxm) View more
NCT00680914 (CTgov)	Phase 3	Streptococcal Infections	503	Pneumococcal vaccine GSK1024850A (Synflorix)+GSK Biologicals' Hiberix™ (Synflorix Group)	hrjwdwgmsm(wsxmwfyuuk) = spotjyhodt mdjpdrvlmk (maoffgxalx, hoqzkobheq - jboprucnay) View more	-	14 Jun 2010
				GSK Biologicals' Hiberix™+Prevenar (Prevenar Group)	hrjwdwgmsm(wsxmwfyuuk) = dlxipwbihm mdjpdrvlmk (maoffgxalx, kyxnfibdlj - gpqfinukha) View more
NCT00696423 (CTgov)	Phase 3	Diphtheria \| Whooping Cough \| Tetanus	467	Hiberix™+Infanrix™ (Infanrix/Hib Single Injection Group)	vsrtjitgel(foqmnbhtuz) = tscbfcipkc ticdfhnetg (hykllykmzj, ukcxidivti - jyueywqvof) View more	-	26 Aug 2009
				Hiberix™+Infanrix™ (Infanrix + Hiberix Separate Injection Group)	vsrtjitgel(foqmnbhtuz) = vocfympswr ticdfhnetg (hykllykmzj, ppyhjeikgs - vdyvbmrcvl) View more