Delving into the Latest Updates on Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Prophylactic vaccine, Conjugated vaccine

Synonyms

DTPa-HBV-IPV-Hib vaccine-GlaxoSmithKline, DTPa-HBV-IPV/Hib Vaccine-GlaxoSmithKline, DTPa-IPV/Hib

+ [12]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesNervous System DiseasesDigestive System Disorders+ [2]

Active Indication

Hepatitis BDiphtheriaHaemophilus Infections+ [3]

Inactive Indication

ChickenpoxFeverMeasles+ [7]

Originator Organization

GSK Plc

Active Organization

GlaxoSmithKline GmbH & Co. KGGlaxoSmithKline Biologicals SA

Inactive Organization

Merck Sharp & Dohme Corp.

GSK Plc

License Organization-

Drug Highest PhaseApproved

First Approval Date

United Kingdom (17 Dec 1998),

DiphtheriaHaemophilus InfectionsPoliomyelitis+ [2]

Regulation-

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A Parallel-group Prevention, Phase II, Partially Blinded, Multi-stage Study to Investigate the Immunogenicity and Safety of Pentavalent Meningococcal ABCYW Vaccine Formulations Compared With Licensed Meningococcal Vaccines When Administered Alone in Healthy Children (2 to 9 Years of Age) or Concomitantly With Routine Pediatric Vaccines in Toddlers (12 to 15 Months of Age) and Infants (2 Months of Age).

This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.

Start Date05 Nov 2024

Sponsor / Collaborator

Sanofi Pasteur SA

NCT04031846

/ CompletedPhase 3

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)

This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.

Start Date04 Sep 2019

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

NCT03632720

/ CompletedPhase 3

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Using a 1+1 Schedule in a National Immunization Schedule Having a Meningococcal Group B Vaccine as Standard of Care

The primary objective of the study was to demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given alone.
The secondary objectives were to compare the hSBA antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was given alone in the second year of life; to describe the hSBA and serum bactericidal assay using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C, W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13 months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate vaccine administered at 3 months of age for Group 1 and Group 2.

Start Date10 Oct 2018

Sponsor / Collaborator

Sanofi Pasteur SA

100 Clinical Results associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)

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100 Translational Medicine associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)

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100 Patents (Medical) associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)

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382

Literatures (Medical) associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline Plc)

01 May 2025·Pediatric Infectious Disease Journal

Acellular Pertussis Vaccine Given in the Week After Birth Does Not Impair Antibody Responses to Later Childhood Doses

Article

Author: McAlister, Sonia M. ; Marshall, Helen S. ; Thornton, Ruth ; van den Biggelaar, Anita H.J. ; Wood, Nicholas ; Cooper, Matthew N. ; Richmond, Peter ; McIntyre, Peter ; Nolan, Terry

Background:A birth acellular pertussis vaccine may be a valuable alternative for immunity against infant pertussis when a pregnancy pertussis vaccine has not been administered. We assessed whether a birth dose may impair immunoglobulin G (IgG) responses to childhood pertussis boosters.Methods:Children from our previous randomized controlled trial who received a monovalent 3-component aP and hepatitis B vaccine at birth (aP group) or hepatitis B only (control group) followed by Infanrix hexa at 2, 4 and 6 months of age were randomized to receive either high or low-dose diphtheria-tetanus acellular pertussis combination vaccine (DTPa—Infanrix/dTpa—Boostrix) at 18 months and 4 years of age. Serum DTPa-specific IgG was measured pre- and postboost at 18 months and 4 years to determine immunogenicity and potential hyporesponsiveness across vaccination schedules.Results:Children who received a neonatal aP dose had improved pertussis toxin-IgG persistence and enhanced postvaccination pertactin and filamentous hemagglutinin-IgG responses at 18 months. Hyporesponsiveness was not detected across the study period, and all schedules showed good immunogenicity to subsequent boosters. The high-dose DTPa vaccine consistently induced higher antibody titers than the low-dose dTpa vaccine. Either booster dose was able to bridge immunity between 6 months and 4 years.Conclusions:A birth dose of acellular pertussis vaccine does not impair antibody responses to booster doses of pertussis vaccines and may be an alternative for protection against early infant pertussis when pertussis booster has not been administered during pregnancy.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Disparate kinetics in immune response of two different Haemophilus influenzae type b conjugate vaccines: Immunogenicity and safety observations from a randomized controlled phase IV study in healthy infants and toddlers using a 2+1 schedule

Article

Author: Bosis, Samantha ; Horn, Michael ; Cheuvart, Brigitte ; Virk, Navpreet ; Jakes, Rupert W. ; Salamanca de la Cueva, Ignacio ; Duchenne, Maurine ; Westerholt, Soeren ; Martinón-Torres, Federico ; Meyer, Nadia ; Van den Steen, Peter

Since the introduction of Haemophilus Influenzae type b (Hib) conjugate vaccines, invasive Hib disease has strongly declined worldwide, yet continued control of Hib disease remains important. In Europe, currently three different hexavalent combination vaccines containing Hib conjugates are marketed. In this phase IV, single-blind, randomized, controlled, multi-country study (NCT04535037), we aimed to compare, in a 2 + 1 vaccination schedule, the immunogenicity and safety and show non-inferiority, as well as superiority, of DTPa-HBV-IPV/Hib (Ih group) versus DTaP5-HB-IPV-Hib (Va group) in terms of anti-polyribosylribitol phosphate (PRP) antibody geometric mean concentrations (GMCs) and proportion of participants reaching anti-PRP antibody concentrations greater than or equal to a threshold of 5 µg/mL. One month after the booster vaccination, the anti-PRP antibody GMC ratio (Ih group/Va group) was 0.917 (95% CI: 0.710-1.185), meeting the non-inferiority criteria. The difference in percentage of participants (Ih group - Va group) reaching GMCs ≥5 µg/mL was -6.3% (95% CI: -14.1% to 1.5%), not reaching the predefined non-inferiority threshold. Interestingly, a slightly higher post-booster antibody avidity was observed in the Ih group versus the Va group. Both vaccines were well tolerated, and no safety concerns were raised. This study illustrates the different kinetics of the anti-PRP antibody response post-primary and post-booster using the two vaccines containing different Hib conjugates and indicates a potential differential impact of concomitant vaccinations on the anti-PRP responses. The clinical implications of these differences should be further studied.

12 Apr 2024·The Journal of Infectious Diseases

Modeling Poliovirus Transmission and Responses in New York State

Article

Author: Rosenberg, Eli S ; Thompson, Kimberly M ; Zucker, Jane R ; Badizadegan, Kamran ; Brenner, I Ravi ; Routh, Janell A ; Kalkowska, Dominika A ; Sugerman, David E ; Burns, Cara C ; Langdon-Embry, Marisa

AbstractBackgroundIn July 2022, New York State (NYS) reported a case of paralytic polio in an unvaccinated young adult, and subsequent wastewater surveillance confirmed sustained local transmission of type 2 vaccine-derived poliovirus (VDPV2) in NYS with genetic linkage to the paralyzed patient.MethodsWe adapted an established poliovirus transmission and oral poliovirus vaccine evolution model to characterize dynamics of poliovirus transmission in NYS, including consideration of the immunization activities performed as part of the declared state of emergency.ResultsDespite sustained transmission of imported VDPV2 in NYS involving potentially thousands of individuals (depending on seasonality, population structure, and mixing assumptions) in 2022, the expected number of additional paralytic cases in years 2023 and beyond is small (less than 0.5). However, continued transmission and/or reintroduction of poliovirus into NYS and other populations remains a possible risk in communities that do not achieve and maintain high immunization coverage.ConclusionsIn countries such as the United States that use only inactivated poliovirus vaccine, even with high average immunization coverage, imported polioviruses may circulate and pose a small but nonzero risk of causing paralysis in nonimmune individuals.

100 Deals associated with Diphtheria (D), Tetanus (T), Pertussis (Acellular, Component) (Pa), Hepatitis B (Rdna) (Hbv), Poliomyelitis (Inactivated) (Ipv) And Haemophilus Influenzae Type-B (Hib) Conjugate Vaccine(Glaxosmithkline 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
Diphtheria	United Kingdom	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Diphtheria	Greece	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Diphtheria	Slovakia	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Diphtheria	Germany	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Diphtheria	Ireland	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Diphtheria	Portugal	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Diphtheria	Finland	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Haemophilus Infections	Ireland	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Haemophilus Infections	Greece	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Haemophilus Infections	Germany	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Haemophilus Infections	Slovakia	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Haemophilus Infections	United Kingdom	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Haemophilus Infections	Portugal	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Haemophilus Infections	Finland	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Whooping Cough	United Kingdom	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Whooping Cough	Ireland	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Whooping Cough	Portugal	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Whooping Cough	Greece	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Whooping Cough	Slovakia	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998
Whooping Cough	Finland	GlaxoSmithKline GmbH & Co. KG	17 Dec 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Streptococcal Infections	Preclinical	Sweden	GSK Plc	01 Jan 2006
Streptococcal Infections	Preclinical	Denmark	GSK Plc	01 Jan 2006
Streptococcal Infections	Preclinical	Norway	GSK Plc	01 Jan 2006
Streptococcal Infections	Preclinical	Slovakia	GSK Plc	01 Jan 2006
Diphtheria	Preclinical	-	GSK Plc	01 Jan 1999
Haemophilus Infections	Preclinical	-	GSK Plc	01 Jan 1999
Hepatitis B	Preclinical	-	GSK Plc	01 Jan 1999
Poliomyelitis	Preclinical	-	GSK Plc	01 Jan 1999
Tetanus	Preclinical	-	GSK Plc	01 Jan 1999
Whooping Cough	Preclinical	-	GSK Plc	01 Jan 1999

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03632720 (CTgov)	Phase 3	Meningococcal Infections	788	Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months))	iwtpwanoob(twtqyfinjl) = zmrqoeqnbl xfaaghaxic (rxyegngbyn, furupnizbi - gzvtxeebav) View more	-	07 Nov 2023
				Meningococcal group B vaccine+Meningococcal polysaccharide (serogroups A,C,Y+Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine+Human rotavirus RIX4414 strain vaccine+Pneumococcal 13-valent polysaccharide conjugate vaccine (Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months))	iwtpwanoob(twtqyfinjl) = zywabfszgk xfaaghaxic (rxyegngbyn, izxdvlwqry - xzgmmboxrl) View more
NCT04031846 (V114-025 \| PNEU-PED-EU-1, CTgov)	Phase 3	Pneumococcal Infections	1,184	Infanrix™ hexa+Rotarix™+V114 (V114)	(mrnhbojmlr) = gtlhurndwf iqbbacibgu (pqquxoutxb, kxddviddut - cyvyzgdbxy) View more	-	03 May 2023
				Infanrix™ hexa+Rotarix™+Prevenar 13™ (Prevenar 13™)	(mrnhbojmlr) = rbrfbziopl iqbbacibgu (pqquxoutxb, gkhryfzbdy - ziprauljjb) View more
NCT00624819 (CTgov)	Phase 3	Pneumonia, Pneumococcal	524	GSK1024805A+Varilrix+Infanrix hexa+Havrix (Synflorix + Infanrix + Havrix and/or Varilrix Group)	echyehtuew(fymyklzbrn) = zancuykhwa fyfttfsjmy (plkkascjsu, vgsptprapb - jzcyllhude) View more	-	18 Mar 2020
				Varilrix+Infanrix hexa+Havrix+Prevenar (Prevenar + Infanrix + Havrix and/or Varilrix Group)	echyehtuew(fymyklzbrn) = drcsvdnodk fyfttfsjmy (plkkascjsu, emlyxwmtpp - amexoywiev) View more
NCT02853929 (CTgov)	Phase 4	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	551	Infanrix hexa (dTpa Group)	ecbocimvxv(bxcwtagjaz) = fzgipzohad xewnzjnwig (ztlbrwpkre, obsjbkoeua - vjlyrrmjxu) View more	-	14 Jan 2020
				Infanrix hexa (Control Group)	ecbocimvxv(bxcwtagjaz) = azddjuizxa xewnzjnwig (ztlbrwpkre, tpdbxnigfb - dnrutvzclz) View more
NCT02422264 (CTgov)	Phase 4	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	601	Infanrix hexa+Prevnar13 (dTpa Group)	frodlkzmjc(cnfqpeicry) = wjioihsswd ezistiolkh (yzxsysppyw, pzitmepjyy - tcyjegayua) View more	-	10 Jun 2019
				Infanrix hexa+Prevnar13 (Control Group)	frodlkzmjc(cnfqpeicry) = wsudxqxkva ezistiolkh (yzxsysppyw, gsmwnbmted - tzpmzsacct) View more
NCT01144663 (CTgov)	Phase 3	Meningococcal Infections	2,095	Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 3 Group)	gngxejhhwy(ipnfaajpbl) = fibuqdehvl atvzloawxl (bqimtqjmtj, fichdnkkzs - quyeqofgme) View more	-	01 Feb 2019
				Synflorix™+Nimenrix™+Infanrix™ hexa (Nimenrix 2 Group)	gngxejhhwy(ipnfaajpbl) = qlvjvsswcv atvzloawxl (bqimtqjmtj, aqxmsgecja - rrvgznrhio) View more
NCT01353703 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	224	Infanrix hexa™ (Infanrix Hexa 6-10-14 Group)	ldknveqbek(dcbfatrmlj) = xdmwlwmugm oyutvwrkao (oflqsaudik, rjydhxdbfa - fofsuxvdti) View more	-	25 Jan 2019
				Infanrix hexa™ (Infanrix Hexa 2-4-6 Group)	ldknveqbek(dcbfatrmlj) = wiuxddohyj oyutvwrkao (oflqsaudik, itkuhylbly - mjkeejqgck) View more
NCT00508261 (CTgov)	Phase 3	Meningococcal Infections	793	Nimenrix+Infanrix-hexa (Nimenrix + Infanrix-hexa Group)	ihqmathhws(kqkciwyzse) = khbvsuxukk mwmifippno (pdwuhjonpw, wwbqsobiaf - znwzqhotyc) View more	-	24 Jan 2019
				Infanrix-hexa™ vaccine+Nimenrix™ vaccine (Nimenrix Group)	ihqmathhws(kqkciwyzse) = ubbaloqgpc mwmifippno (pdwuhjonpw, rkscejfapk - ezkzbzkzsu) View more
NCT00496015 (CTgov)	Phase 3	Streptococcal Infections	750	Pneumococcal conjugate vaccine GSK1024850A.+Paracetamol.+Infanrix hexa. (Synflorix I Group)	cgurtnchjq(nwydncauni) = qokqxwnjfl zinqzfgwez (sjwsophhed, tpbslygblw - ndbopcbqkp) View more	-	18 Jan 2019
				Pneumococcal conjugate vaccine GSK1024850A.+Infanrix hexa. (Synflorix II Group)	cgurtnchjq(nwydncauni) = hxatsjiyso zinqzfgwez (sjwsophhed, pohossujnb - ixifsqunvd) View more
NCT00390910 (CTgov)	Phase 3	Streptococcal Infections	286	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group III)	oqngrrlvtr(ekqwjukxlu) = ndinxarayz ffovzlrvkd (biebaggrmk, bxqidtxicn - nbqbcuemdx) View more	-	17 Dec 2018
				Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group I)	ujahznfcnh(georpwzubp) = imqqoxokiy qqptvbtuzc (cxwfndkpgv, wvvrufrtro - yvrvfpluhq) View more