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-

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

US (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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67

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

02 Sep 2021·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Risk factors for delay in starting age-appropriate vaccinations among infants in urban slums of Bangladesh

Q3 · MEDICINE

Article

Author: Khanam, Afsana ; Ahmad, Shaikh Meshbahuddin ; Afsar, Md. Nure Alam ; Alam, Md Jahangir

Age-appropriate vaccination is crucial for infants, protecting them from vaccine-preventable diseases. Delaying in starting initial immunization may result in incomplete or non-vaccination in early life. However, limited vaccine coverage data are available regarding the starting age of vaccination. In this study, we determined the factors associated with the delay in infant immunization. We carried out a cross-sectional study at three maternal-child health clinics in Dhaka city. Mothers visited these clinics for their infant immunization were surveyed with structured questionnaires. A multivariate logistic regression model was used to estimate the significant influencing factors on untimely vaccination. A total of 548 mother-infant pairs were surveyed. 46.5% of mothers did not receive Tetanus (TT) vaccines, and mothers who had a previous pregnancy were less likely to receive TT-vaccine (p < .01). 41.2% of infants did not receive BCG vaccines within 1-week of birth. Mothers working outside the home showed a negative impact on BCG vaccination (p < .05). Among the infants' born in-clinic facilities, 39% were BCG unvaccinated, and 69% had c-section delivery. The median age of infants for starting vaccination was 6.57 wks (95% CI: 6.43-7.14); however, 17.3% infants received vaccination at ≥8 wks of age. Mother's schooling-years and infant normal body-weight positively associated with vaccination at <8 wks, whereas sickness after birth increased the age to start vaccination program recommended at 6 wks. Our analysis suggests the need for specific interventions based on potential maternal determinants, such as educating mothers about the timing and the importance of infant immunization, and addressing programmatic barriers to timely vaccination among infants in Bangladesh.

01 Mar 2020·VaccineQ3 · MEDICINE

Higher mass meningococcal group C-tetanus toxoid vaccines conjugated with carbodiimide correlate with greater immunogenicity

Q3 · MEDICINE

Article

Author: Eastwood, David ; Gao, Fang ; Francis, Robert J ; Derrick, Jeremy P ; Bolgiano, Barbara ; Stebbings, Richard ; Lockyer, Kay ; Khatri, Bhagwati

To examine the link between meningococcal C (MenC) vaccine size and immunogenic response, a panel of MenC glycoconjugate vaccines were prepared differing in chain length, molar mass and hydrodynamic volume. The preparations consisted of different lengths of MenC polysaccharide (PS) covalently linked to monomeric purified tetanus toxoid (TT) carrier protein using the coupling reagent ethylcarbodiimide hydrochloride (EDC). Size exclusion chromatography with multi-angle light scattering (SEC-MALS) and viscometry analysis confirmed that the panel of MenC-TT conjugates spanned masses of 191,500 to 2,348,000 g/mol, and hydrodynamic radii ranging from 12.1 to 47.9 nm. The two largest conjugates were elliptical in shape, whereas the two smallest conjugates were more spherical. The larger conjugates appeared to fit a model described by multiple TTs with cross-linked PS, typical of lattice-like networks described previously for TT conjugates, while the smaller conjugates were found to fit a monomeric or dimeric TT configuration. The effect of vaccine conjugate size on immune responses was determined using a two-dose murine immunization. The two larger panel vaccine conjugates produced higher anti-MenC IgG1 and IgG2b titres after the second dose. Larger vaccine conjugate size also stimulated greater T-cell proliferative responses in an in vitro recall assay, although cytokines indicative of a T-helper response were not measurable. In conclusion, larger MenC-TT conjugates up to 2,348,000 g/mol produced by EDC chemistry correlate with greater humoral and cellular murine immune responses. These observations suggest that conjugate size can be an important modulator of immune response.

01 Jun 2019·Pediatric Infectious Disease JournalQ4 · MEDICINE

Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers

Q4 · MEDICINE

Article

Author: Jastorff, Archana ; Marshall, Helen S ; Ziegler, John B ; Richmond, Peter ; Booy, Robert ; Baine, Yaela ; Nolan, Terry ; Nissen, Michael ; Van der Wielen, Marie ; Traskine, Magali

Background:We assessed immunogenicity, antibody persistence and safety of the meningococcal serogroups A, C, W and Y-tetanus toxoid (TT) conjugate vaccine (MenACWY-TT) in children primed as toddlers with MenC vaccine.Methods:This open, multicenter extension study enrolled children 84–95 months of age who had received one dose of the combined Haemophilus influenzae type b (Hib)-MenC-TT conjugate vaccine (HibMenC group) or Hib-TT and monovalent MenC (MCC)-CRM197 vaccines (Hib+MCC group) at 12–18 months of age, in the primary study. All participants received one dose of MenACWY-TT. We assessed immunogenicity against MenA, MenC, MenW and MenY at 1 month and 2 years postvaccination by serum bactericidal assay using baby rabbit complement (rSBA). Safety and reactogenicity were evaluated.Results:Six years post-MenC vaccination, <20% of children retained rSBA-MenC titers ≥1:8. At 1 month post-MenACWY-TT vaccination, vaccine response rates against all serogroups were high for both groups with ≥97.1% of children having rSBA ≥1:8. Two years postvaccination, ≥63.6% of children retained rSBA-MenA ≥1:8, and ≥87.9% for other serogroups. Geometric mean titers for all serogroups declined at 2 years post-MenACWY-TT vaccination, but remained ≥13 times higher than prevaccination levels. For both groups, pain (≤58.5%), redness (≤51.4%) and fatigue (≤27.0%) were the most frequently reported adverse events. No serious adverse events were reported.Conclusions:One dose of MenACWY-TT boosts protection against MenC in primed children, is safe and extends protection against MenA, MenW and MenY. Immunogenicity and safety were comparable in infants vaccinated with conjugated vaccine (HibMenC-TT) or the separate vaccines (Hib-TT and MCC-CRM197).

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	US	GlaxoSmithKline LLC	14 Jun 2012
Meningitis	Discovery	MX	GSK Plc	22 Feb 2006
Meningitis	Discovery	US	GSK Plc	22 Feb 2006
Meningitis	Discovery	AU	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)	rwymazcaii(ogbwdzikmq) = xwddxjriiz cvioqodyve (rrdpsnkugb, iqzvkomuqs - rwxryyupqt) View more	-	26 Jun 2018
				Rotarix®+PedvaxHIB®+Havrix®+Prevnar 13®+Pediarix® (PedHIB Group)	rwymazcaii(ogbwdzikmq) = bxewpnnszl cvioqodyve (rrdpsnkugb, ptgfmqbsrt - hxrysyfjfn) View more
NCT00614614 (Pubmed \| Vaccine)	Phase 3	-	1,558	HibMenCY-TT+ DTaP-HBV-IPV vaccine	(qvpomnfckd) = ndpdpqhnuf bspuqssovy (lzhufbfzfs ) View more	-	11 Feb 2015
NCT00129129 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	756	GSK Biologicals' Haemophilus influenza type b+Prevnar+Pediarix (MenHibrix Group)	lrdjcmonyz(ddpyhkaiuq) = lbozsjeqwn qxlmeastzy (wxtxhecmmh, abtfabmykh - iqjjezyqzj) View more	-	30 Dec 2013
				ActHIB+Prevnar+Pediarix (ActHIB Group)	lrdjcmonyz(ddpyhkaiuq) = mbwfnhrfap qxlmeastzy (wxtxhecmmh, hthwlzndbz - ykskisajcs) 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)	ubwgehnaau(pfenhymtzh) = zokmxkxfcf xjsncwkdlz (xpyntidpzl, kuithcbkrp - smgkivekzz) View more	-	06 Aug 2012
				GSK Biologicals' Haemophilus influenzae type b+Varivax+Prevnar+Pediarix+M-M-R II (Menhibrix B Group)	ubwgehnaau(pfenhymtzh) = xrjvfhdcgm xjsncwkdlz (xpyntidpzl, jhibyptjrn - fnjwanbunx) View more
NCT00129116 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	388	Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F1/Infanrix-penta Group)	fzmhvmkulr(idujkwymsh) = mhhvbijkek idpsasymcy (hjpopmtraz, rzwtsdtmsl - xydaymevhw) View more	-	23 Jul 2012
				Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F2/Infanrix-penta Group)	fzmhvmkulr(idujkwymsh) = khzbanfiwb idpsasymcy (hjpopmtraz, fzcxoqqqjz - iuqcwkxaqh) 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)	yrncpgchbp(vfjvgvdlck) = mwippfvasb rhhiwespoy (coetykawln, mstxabzxlq - ycdqvayann) View more	-	23 Jul 2012
				PRP (Polyribosyl Ribitol Phosphate)+Mencevax® ACWY+Hib-MenCY-TT vaccine (MenHibrix)+Prevenar®+Infanrix® Penta (MenHibrix Formulation 2 Group)	yrncpgchbp(vfjvgvdlck) = gtbwteczgb rhhiwespoy (coetykawln, iidtdtjyvg - fnqqkfdohm) View more
NCT00359983 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	270	MenHibrix (Hib-MenCY-TT) (MenHibrix 4-dose Group)	qnbczosjzk(ehmxbfbwfi) = owslvghmyp boorhkxgfd (ltacoojgep, gcwagxqrei - gwuxdoqtky) View more	-	20 Jul 2012
				Hib conjugate vaccine (ActHIB) (ActHIB 4-dose Group)	qnbczosjzk(ehmxbfbwfi) = tythtsrmdu boorhkxgfd (ltacoojgep, hmloixpoph - micpxdkkyx) View more
NCT00134719 (CTgov)	Phase 2	Meningitis \| Haemophilus Infections	1,104	MenHibrix (Hib-MenCY-TT)+M-M-R®II+Varivax®+Prevenar®+Infanrix® Penta (MenHibrix Group)	naascrdjwc(pxkflbiwvl) = pyyaqfmzft syydpsnnxa (uqwejfkcgi, msyqumyfrs - vwclnafqvm) View more	-	20 Jul 2012
				ActHIB®+MenHibrix (Hib-MenCY-TT)+M-M-R®II+Varivax®+Prevenar®+Infanrix® Penta+Meningitec® (ActHIB + Meningitec Group)	xnyfwevhfi(iuboygmfxa) = fnoadugsvw plxyeqncte (ssawirbjtw, cmczgbarxa - hwkxhvjtyw) View more
NCT00345683 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,021	Neisseria meningitidis serogroups C+Varivax+Prevnar+M-M-R II (Menhibrix Group)	ovtqajkcxi(qfxpikskma) = bpwwerysqp bwhxhlbmbm (zuyhhnhkig, aozfitrojk - thhgpiiwrx) View more	-	20 Jul 2012
				PedvaxHIB+Varivax+Prevnar+M-M-R II (ActHIB Group)	ovtqajkcxi(qfxpikskma) = tcylnpcilu bwhxhlbmbm (zuyhhnhkig, fjibfvqeok - hbhtfmphjg) View more
NCT00345579 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	4,432	Neisseria meningitidis serogroups C+Pediarix/Infanrix Penta (MenHibrix Group)	xeuuzwgwrs(bkkfpcducj) = pkpovggfks fhkbynwtma (kzrkpjbqzq, fpoxwlllov - mpxdutoznl) View more	-	20 Jul 2012
				ActHIB+Pediarix/Infanrix Penta (ActHIB Group)	xeuuzwgwrs(bkkfpcducj) = wmyblpcdwq fhkbynwtma (kzrkpjbqzq, rvvcsjobay - bstwzzixqh) View more