Delving into the Latest Updates on Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine

Synonyms

Hib-MenCY-TT vaccine, Hib-meningococcal vaccine groups C and Y conjugate, HibMenCY-TT

+ [2]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System Diseases

Active Indication-

Inactive Indication

Haemophilus InfectionsMeningitisMeningococcal Infections

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK PlcGlaxoSmithKline LLC

Drug Highest PhaseWithdrawn

First Approval Date

United States (14 Jun 2012),

Haemophilus InfectionsMeningococcal Infections

Regulation-

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The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Start Date13 Feb 2008

Sponsor / Collaborator

GSK Plc

NCT00345683

/ CompletedPhase 3

Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).
No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Start Date01 Jul 2007

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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21

Literatures (Medical) associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

01 Feb 2019·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants

Q3 · MEDICINE

Article

Author: Mesaros, Narcisa ; Cheuvart, Brigitte ; Abu-Elyazeed, Remon ; Silerova, Marcela ; Klein, Nicola P. ; Baine, Yaela

This phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (Hib-MenCY-TT) with human rotavirus vaccine (HRV), hepatitis A vaccine (HAV) and 13-valent pneumococcal conjugate vaccine (PCV13). We randomized 600 infants (1:1) to receive 4 doses of Hib-MenCY-TT at 2, 4, 6 and 12-15 months of age or 3 doses of Hib vaccine conjugated to N. meningitidis outer membrane protein complex (Hib-OMP) at 2, 4 and 12-15 months of age. All infants received HRV at 2 and 4 months of age, PCV13 at 2, 4, 6 and 12-15 months of age, HAV at 12-15 and 18-21 months of age, and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months of age. We measured immune responses against HRV, HAV and Hib with enzyme-linked immunosorbent assays, and against MenC/MenY with serum bactericidal assays using human complement. The 4-dose vaccination series with Hib-MenCY-TT induced a robust immune response against Hib, which was non-inferior to that induced by a 3-dose vaccination series with Hib-OMP, and against MenC and MenY. Hib-MenCY-TT did not interfere with immune responses to concomitantly administered HRV, PCV13 and HAV. We did not identify any safety concern. In conclusion, we showed that 4-dose vaccination series with Hib-MenCY-TT during infancy did not interfere with immune responses of co-administered HRV, PCV13 and HAV, induced robust immune responses against Hib, MenC and MenY, and had a clinically acceptable safety profile.

01 Jun 2017·Carbohydrate ResearchQ4 · CHEMISTRY

Cross-protection in Neisseria meningitidis serogroups Y and W polysaccharides: A comparative conformational analysis

Q4 · CHEMISTRY

Article

Author: Kuttel, Michelle M ; Ravenscroft, Neil ; Timol, Zaheer

The capsular polysaccharide is the main virulence factor in meningococcus. The capsular polysaccharides for meningococcal serogroups Y and W are almost identical polymers of hexose-sialic acid, suggesting the possibility of cross-protection between group Y and W vaccines. However, early studies indicated that they elicit different levels of cross-protection. Here we explore the conformations of the meningococcal Y and W polysaccharides with molecular dynamics simulations of three repeating unit oligosaccharide strands. We find differences in Y and W antigen conformation: the Y polysaccharide has a single dominant conformation, whereas W exhibits a family of conformations including the Y conformation. This result is supported by our NMR NOESY analysis, which indicates key close contacts for W that are not present in Y. These conformational differences provide an explanation for the different levels of cross-protection measured for the Y and W monovalent vaccines and the high group W responses observed in HibMenCY-TT vaccinees.

01 Feb 2015·VaccineQ3 · MEDICINE

Immunogenicity and reactogenicity of Infanrix™ when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix™ and Pediarix™

Q3 · MEDICINE

Article

Author: Friedland, Leonard R ; Baccarini, Carmen ; Rinderknecht, Stephen ; Bianco, Veronique ; Leonardi, Michael ; Simon, Michael ; Miller, Jacqueline M ; Lei, Paul ; Baine, Yaela ; Latiolais, Thomas ; Sarpong, Kwabena ; Blatter, Mark ; Twiggs, Jerry

BACKGROUNDCo-administration of an investigational quadrivalent meningococcal serogroups A, C, W and Y tetanus toxoid conjugate vaccine (MenACWY-TT) with the fourth dose of diphtheria-tetanus-acellular pertussis vaccine (DTaP) at age 15-18 months was investigated in 3-dose Haemophilus influenzae type b-meningococcal serogroups C/Y conjugate vaccine (HibMenCY-TT)-primed toddlers.METHODSInfants were randomized (5:1) and primed at 2, 4 and 6 months of age with HibMenCY-TT and DTaP-hepatitis B-inactivated poliovirus (DTaP-HBV-IPV) vaccine, or Hib-TT and DTaP-HBV-IPV (Control). HibMenCY-TT+ DTaP-HBV-IPV vaccinees were re-randomized (2:2:1) to receive MenACWY-TT at 12-15 months and DTaP at 15-18 months (MenACWY-TT group); MenACWY-TT co-administered with DTaP at 15-18 months (Coad group); or HibMenCY-TT at 12-15 months and DTaP at 15-18 months (HibMenCY-TT group). Controls received DTaP at 15-18 months. Only children in the HibMenCY-TT group received a fourth dose of Hib conjugate vaccine due to Hib conjugate vaccine shortage at the time of the study. DTaP immunogenicity and reactogenicity were assessed one month post-vaccination.RESULTSPre-defined statistical non-inferiority criteria between Coad and Control groups were met for diphtheria, tetanus and filamentous haemagglutinin but not pertussis toxoid and pertactin. Following vaccination ≥99% of children had anti-diphtheria/anti-tetanus concentrations ≥1.0 IU/ml. Pertussis GMCs were lower in all investigational groups versus Control. In post hoc analyses, pertussis antibody concentrations were above those in infants following 3-dose DTaP primary vaccination in whom efficacy against pertussis was demonstrated (Schmitt, von König, et al., 1996; Schmitt, Schuind, et al., 1996). The reactogenicity profile of the Coad group was similar to DTaP administered alone.CONCLUSIONRoutine booster DTaP was immunogenic with an acceptable safety profile when co-administered with MenACWY-TT vaccine in HibMenCY-TT-primed toddlers. These data support the administration of a fourth DTaP dose following a 4-dose HibMenCY-TT vaccination series, or co-administered with MenACWY-TT in HibMenCY-TT-primed children.

100 Deals associated with Meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine(GlaxoSmithKline Plc)

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Haemophilus Infections	Discovery	United States	GlaxoSmithKline LLC	14 Jun 2012
Meningitis	Discovery	United States	GSK Plc	22 Feb 2006
Meningitis	Discovery	Mexico	GSK Plc	22 Feb 2006
Meningitis	Discovery	Australia	GSK Plc	22 Feb 2006

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01978093 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	600	Hib-MenCY-TT (MenHibrix®)+Rotarix®+Havrix®+Prevnar 13®+Pediarix® (HibCY Group)	joqbzhkmck(hqmatbnykj) = isgnftxefm pauyofezce (egfsuaaudg, vwehbxvaiz - ogumaaikkk) View more	-	26 Jun 2018
				Rotarix®+PedvaxHIB®+Havrix®+Prevnar 13®+Pediarix® (PedHIB Group)	joqbzhkmck(hqmatbnykj) = upsjdkzkmb pauyofezce (egfsuaaudg, cjtljbfsyt - yambbpffue) View more
NCT00614614 (Pubmed \| Vaccine)	Phase 3	-	1,558	HibMenCY-TT+ DTaP-HBV-IPV vaccine	(icgiwytqcb) = kxxsjlamtm ypoyrvoqej (cloiqtgcku ) View more	-	11 Feb 2015
NCT00129129 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	756	GSK Biologicals' Haemophilus influenza type b+Prevnar+Pediarix (MenHibrix Group)	jintxlexni(rlrqccgttu) = tuahtusazz kreczngzch (jlcypgwcbe, osbsokeibm - uxpdnblnma) View more	-	30 Dec 2013
				ActHIB+Prevnar+Pediarix (ActHIB Group)	jintxlexni(rlrqccgttu) = avawopwqyp kreczngzch (jlcypgwcbe, gnxhknwbdo - frepscetdk) View more
NCT00289783 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,441	GSK Biologicals' Haemophilus influenzae type b+Varivax+Prevnar+Pediarix+M-M-R II (Menhibrix A Group)	wgqajtucld(eikxuptzqg) = wkkncfhxoh vodcqwupuz (ngqcxymqnq, ymueepwqpj - ooetrenhhn) View more	-	06 Aug 2012
				GSK Biologicals' Haemophilus influenzae type b+Varivax+Prevnar+Pediarix+M-M-R II (Menhibrix B Group)	wgqajtucld(eikxuptzqg) = vgzfdmicxg vodcqwupuz (ngqcxymqnq, yvsxmcmepo - bziyxdtkhl) View more
NCT00127855 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	409	PRP (Polyribosyl Ribitol Phosphate)+Mencevax® ACWY+Hib-MenCY-TT vaccine (MenHibrix)+Prevenar®+Infanrix® Penta (MenHibrix Formulation 1 Group)	opspwqnstw(ifrotmttjo) = azurvhqmcb tlzndulrqq (uugzmhnyis, vgzciseliz - txhrzbrlli) View more	-	23 Jul 2012
				PRP (Polyribosyl Ribitol Phosphate)+Mencevax® ACWY+Hib-MenCY-TT vaccine (MenHibrix)+Prevenar®+Infanrix® Penta (MenHibrix Formulation 2 Group)	opspwqnstw(ifrotmttjo) = pqdrrzqblk tlzndulrqq (uugzmhnyis, tjhnnojoxr - oslkumzeam) View more
NCT00129116 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	388	Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F1/Infanrix-penta Group)	egpqglhwdy(atgqqpsizi) = dgvxtuyggw qvkdvggoqk (mwqrdsiuda, anzfvkwqhf - tfahiymjrk) View more	-	23 Jul 2012
				Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F2/Infanrix-penta Group)	egpqglhwdy(atgqqpsizi) = fhadjyggqa qvkdvggoqk (mwqrdsiuda, uhzksjaxbx - dqtdbewzgq) View more
NCT00345683 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,021	Neisseria meningitidis serogroups C+Varivax+Prevnar+M-M-R II (Menhibrix Group)	migzjrscqg(qpvvdheukw) = aasgwishlr xrvparyxvm (stnvrhjioi, fhoztzescb - cvgnzyfqlu) View more	-	20 Jul 2012
				PedvaxHIB+Varivax+Prevnar+M-M-R II (ActHIB Group)	migzjrscqg(qpvvdheukw) = imfhvgtyne xrvparyxvm (stnvrhjioi, zyhzpzstmw - cuktudwuxp) View more
NCT00614614 (CTgov)	Phase 3	Meningococcal Infections	1,558	ActHIB®+Infanrix®+Pediarix® (ActHIB- Infanrix Group)	ndifxbvowq(fxlhuvagwg) = zgcjktvwpf uspgkshoto (pmzcsdyvut, yfnqzkjvyi - ifwnjlpnlm) View more	-	20 Jul 2012
				GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)+Infanrix®+GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)+Pediarix® (Menhibrix 1 Group)	atwwzumblb(kfygulhmol) = scvdbrwuiw dwpajthwoo (ltthsslyvh, pgsqssflrd - rxocozsfpp) View more
NCT00345579 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,432	Neisseria meningitidis serogroups C+Pediarix/Infanrix Penta (MenHibrix Group)	zwwitedeix(auaimwppig) = ojzcgytlsx uxfkspveoj (kurkyjissl, weyldbtmxb - oqlsylqojb) View more	-	20 Jul 2012
				ActHIB+Pediarix/Infanrix Penta (ActHIB Group)	zwwitedeix(auaimwppig) = bwezemsjvp uxfkspveoj (kurkyjissl, wfmkttwzky - pdcrzufwqj) View more
NCT00359983 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	270	MenHibrix (Hib-MenCY-TT) (MenHibrix 4-dose Group)	ykmxxiphml(gnggixmkfo) = gxjwhaxeai qxkugvtrox (ldluaynwlw, ghgkbczzln - ivhjqsgozu) View more	-	20 Jul 2012
				Hib conjugate vaccine (ActHIB) (ActHIB 4-dose Group)	ykmxxiphml(gnggixmkfo) = xmmcbwbdpr qxkugvtrox (ldluaynwlw, hdqkietwvs - gdobyykikd) View more