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

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

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

NCT02853929 / CompletedPhase 4

Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Infanrix Hexa™ (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.

Start Date19 Sep 2016

Sponsor / Collaborator

GSK Plc

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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292

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)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Available evidence on the co-administration of the four-component meningococcal B vaccine (4CMenB) with three vaccines at the same visit among pediatric individuals

Review

Author: Prato, Rosa ; Russo, Rocco ; Giuffrida, Sandro ; Gabutti, Giovanni ; Castagna, Stefano ; Marchetti, Federico ; Bonanni, Paolo ; Vitale, Francesco

Vaccine co-administration is a useful strategy for improving vaccine coverage and adherence. In Italy, an update to the national immunization program (NIP) in 2023 included recommendations for co-administration of pediatric vaccines, including the four-component vaccine for meningococcus B (4CMenB), pneumococcal conjugate vaccine (PCV), hexavalent vaccines, and oral rotavirus vaccines. Safety is a major concern when considering vaccine co-administration; therefore, a literature review of the available evidence on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines was performed. Of 763 publications screened, two studies were reviewed that reported safety data on 4CMenB co-administration with PCV, hexavalent/pentavalent, and rotavirus vaccines in infants aged 0-24 months. Overall, these studies supported that there were no significant safety signals when co-administering 4CMenB with PCV, hexavalent/pentavalent, and rotavirus vaccines, compared with individual vaccination. This review provides key insights for healthcare professionals on the tolerability of co-administering 4CMenB with routine vaccines.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Antibody persistence to diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens, and Haemophilus influenzae type b following primary and first booster with pentavalent versus hexavalent vaccines

Article

Author: Sarawanangkoor, Nasiri ; Poovorawan, Yong ; Thongmee, Thanunrat ; Thatsanathorn, Thaksaporn ; Wanlapakorn, Nasamon ; Srimuan, Donchida

Thailand has incorporated the whole-cell (wP) pertussis vaccine into the expanded program on immunization since 1977 and has offered the acellular pertussis (aP) vaccine as an optional vaccine for infants since 2001. We followed healthy children from a clinical trial (ClinicalTrials.gov NCT02408926) in which children were randomly assigned to receive either pentavalent (DTwP-HB-Hib) or hexavalent (DTaP-IPV-HB-Hib) vaccines for their primary series (administered at 2, 4, and 6 months) and first booster vaccination (18 months). Both groups received Tdap-IPV as a second booster at the age of 4 y. Blood samples were collected for evaluation of antibody persistence to diphtheria toxoid (DT), tetanus toxoid (TT), and Bordetella pertussis (B. pertussis) between 2 and 6 y of age annually, and for the immunogenicity study of Tdap-IPV at 1 month after the second booster. Antibody persistence to Haemophilus influenzae type b (Hib) was followed until 3 y of age. A total of 105 hexavalent-vaccinated children and 91 pentavalent-vaccinated children completed this study. Both pentavalent and hexavalent groups demonstrated increased antibody levels against DT, TT, and B. pertussis antigens following the second booster with Tdap-IPV. All children achieved a seroprotective concentration for anti-DT and anti-TT IgG at 1 month post booster. The hexavalent group possessed significantly higher anti-pertactin IgG (adjusted p = .023), whereas the pentavalent group possessed significantly higher anti-pertussis toxin IgG (adjusted p < .001) after the second booster. Despite declining levels post-second booster, a greater number of children sustained protective levels of anti-DT and anti-TT IgG compared to those after the first booster.

31 Dec 2024·Human Vaccines & Immunotherapeutics

Acceptance and willingness to pay for DTaP-HBV-IPV-Hib hexavalent vaccine among parents: A cross-sectional survey in China

Article

Author: Zhang, Bingling ; Tang, Lin ; Liu, Jiajie ; Huang, Lifang ; Wang, Yu ; Wang, Lei ; Xu, Xia ; Wang, Fuzhen ; Li, Jun ; Zhang, Xue ; Zhou, Yang ; Liu, Qianqian ; Huang, Aodi ; Zhang, Qian ; Liu, Siyu ; Zhou, Zemei ; Yin, Zundong ; Wang, Xiaoqi

DTaP-HBV-IPV-Hib hexavalent vaccine has been used in high-income countries for many years to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive Haemophilus influenzae type b disease. Currently, no hexavalent vaccines have been approved for use in China. Evidence of parental acceptance and interest in hexavalent vaccines can help policy makers and manufacturers make decisions about entering the vaccine market and the immunization program in China. We measured parental acceptance and willingness-to-pay (WTP) for a hexavalent vaccine to provide such evidence. We conducted a cross-sectional survey of children's caregivers in 16 vaccination clinics in seven cities in China and obtained information on socio-demographics, knowledge of disease, confidence in vaccines, previous vaccination experience, and acceptance of and WTP for hexavalent vaccine. Multivariate logistic regression was used to determine factors influencing acceptance, and multivariate tobit regression was used to identify factors impacting WTP. Between April 28 and June 30, 2023, a total of 581 parents of children aged 0-6 years participated in the survey; 435 (74.87%, 95% CI:71.3%-78.4%) parents indicated acceptance of hexavalent vaccine. Residence location, parents' education level, experience paying for vaccination, and disease knowledge scores were key factors affecting parents' choices for vaccination. Mean (SD) and median (IQR) willingness to pay for full 4-dose course vaccination were 2266.66 (1177.1) CNY and 2400 (1600-2800) CNY. Children's age (p < .001), parents' education level (p = .024), and perceived price barriers (p < .001) were significantly associated with WTP. Parents have high acceptance and willingness to pay for hexavalent vaccine. The less money parents have to pay out of pocket, the more willing they can be to accept the vaccine. Therefore, acceptance may increase even further if the vaccine is covered by medical insurance, provided free of charge by the government, or if its price is reduced. Our results provide reference for optimizing and adjusting immunization strategies in China.

1

News (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)

26 Sep 2023

·www.biospace.com

Surface Solutions Group to Introduce Sustainable, Compliant GlideMed™ Medical Device Coating at MD&M Minneapolis

CHICAGO--(BUSINESS WIRE)-- ISO 13485 certified Surface Solutions Laboratories (SSG), a leading provider of coating technologies for the medical device industry, today announced that it will be showcasing its GlideMed™ sustainable, compliant coating and its 12 other coating solutions in Booth #3226 at the Medical Design & Manufacturing Conference & Expo (MD&M) in Minneapolis on October 10-11, 2023. MD&M attendees are invited to meet with SSG’s team and learn more about GlideMed™, a water-based, low friction coating for medical devices. Available in No PTFE and Low PTFE formulations, it is free from PFOS, PFOA, solvent and hexavalent chromium. Developed using established, proven coating technology, it is biocompatible, environmentally friendly, and REACH and RoHS compliant. Certain chemicals have come under increased scrutiny by the US Environmental Protection Agency and EU Medical Device Regulation. “This is a significant change for medical device companies and their design engineers who are increasingly seeking functional coatings that meet or exceed regulatory requirements,” said Kevin Hess, president of SSG. “The response to GlideMed™ from major OEM device manufacturers and their tier one suppliers has been quite positive.” Sustainable GlideMed™ coatings provide excellent adhesion and permanently bonded, low friction properties that are a good alternative to traditional PTFE coatings. Available in a variety of colors, it can be applied to multiple wire configurations, lengths and types, including nitinol, stainless steel alloys, and titanium, and medical devices such as needles, guidewires, coils, cables, mandrels, hypotubes, and continuous wire. About Surface Solutions Group, LLC Surface Solutions Group is dedicated to providing proven coating technologies and solutions for the global medical device industry, and offers 13 categories of functional coatings. With 60 years of coating industry experience, SSG’s extensive automation and state-of-the-art facility provides its customers with consistently applied coatings, and meets or exceeds its customers’ demanding performance and delivery requirements. SSG serves large medical device OEMs and their contract manufacturers, component suppliers, and R&D startups primarily in the cardiovascular, neurovascular, peripheral vascular, orthopedic, surgical, spine, and dental segments. SSG is wholly owned by the Elektrisola group, a privately held company with 19 production plants and 4,700 employees worldwide. To learn more about SSG, visit surfacesolutionsgroup.com, call 773-427-2084 or follow on LinkedIn or Twitter.

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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KEGG	Wiki	ATC	Drug Bank
-	-	J07CA09	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diphtheria	EU	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	NO	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	IS	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	LI	GlaxoSmithKline Biologicals SA	23 Oct 2000
Haemophilus Infections	LI	GlaxoSmithKline Biologicals SA	23 Oct 2000
Haemophilus Infections	NO	GlaxoSmithKline Biologicals SA	23 Oct 2000
Haemophilus Infections	IS	GlaxoSmithKline Biologicals SA	23 Oct 2000
Haemophilus Infections	EU	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	IS	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	LI	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	EU	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	NO	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	IS	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	EU	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	NO	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	LI	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	LI	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	IS	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	NO	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	EU	GlaxoSmithKline Biologicals SA	23 Oct 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chickenpox	Phase 1	IT	Merck Sharp & Dohme Corp.	12 Jan 2007
Chickenpox	Phase 1	DE	Merck Sharp & Dohme Corp.	12 Jan 2007
Fever	Phase 1	CZ	GSK Plc	01 Sep 2006
Rotavirus Infections	Phase 1	CZ	GSK Plc	01 Sep 2006
Diphtheria	Phase 1	-	GSK Plc	01 Feb 2000
Haemophilus Infections	Phase 1	-	GSK Plc	01 Feb 2000
Hepatitis B	Phase 1	-	GSK Plc	01 Feb 2000
Poliomyelitis	Phase 1	-	GSK Plc	01 Feb 2000
Tetanus	Phase 1	-	GSK Plc	01 Feb 2000
Whooping Cough	Phase 1	-	GSK Plc	01 Feb 2000

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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))	hrlvuynfhu(oidnexacyr) = skkmpgzxre bkyfujvvrg (xoriusqeif, pbasebwmlk - qjyvepzykk) 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))	hrlvuynfhu(oidnexacyr) = qzueyergke bkyfujvvrg (xoriusqeif, wvqzhnshyq - ooqmujjpbw) View more
NCT00624819 (CTgov)	Phase 3	Pneumonia, Pneumococcal	524	GSK1024805A+Varilrix+Infanrix hexa+Havrix (Synflorix + Infanrix + Havrix and/or Varilrix Group)	horfvhljye(wauvkfusof) = ifkpmclyki gvhznatges (pncuxaymqc, dnnqyxobih - upfqnxjzlb) View more	-	18 Mar 2020
				Varilrix+Infanrix hexa+Havrix+Prevenar (Prevenar + Infanrix + Havrix and/or Varilrix Group)	horfvhljye(wauvkfusof) = ortsyyzmpm gvhznatges (pncuxaymqc, qoonbtuszg - adsttehtas) View more
NCT02853929 (CTgov)	Phase 4	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	551	Infanrix hexa (dTpa Group)	haupswcpbc(gkhfnpmvds) = lrbsjcvbvx iaartsxlfe (zazdapduwp, tlwqjlught - jrspztvgqm) View more	-	14 Jan 2020
				Infanrix hexa (Control Group)	haupswcpbc(gkhfnpmvds) = ooxzjbjtsz iaartsxlfe (zazdapduwp, jjisjoktzv - tojuipgqre) View more
NCT02422264 (CTgov)	Phase 4	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	601	Infanrix hexa+Prevnar13 (dTpa Group)	wekcxynmmk(zczuspfzgv) = rczjuuwdzu yleohyzkwm (zzhqyuyxni, rlpmyzaons - ldtboqynjh) View more	-	10 Jun 2019
				Infanrix hexa+Prevnar13 (Control Group)	wekcxynmmk(zczuspfzgv) = okrzydngdx yleohyzkwm (zzhqyuyxni, mxzolcgqbh - rdbvxrcsuo) View more
NCT01353703 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	224	Infanrix hexa™ (Infanrix Hexa 6-10-14 Group)	xjuncurnrh(ussnicupzn) = kawbzuwxuh vkktphodyy (dxlvxucfeo, wrvdezvttc - ujmpevarku) View more	-	25 Jan 2019
				Infanrix hexa™ (Infanrix Hexa 2-4-6 Group)	xjuncurnrh(ussnicupzn) = itnvnxbdtt vkktphodyy (dxlvxucfeo, txvbhdciri - edomaiuwhx) View more
NCT00496015 (CTgov)	Phase 3	Streptococcal Infections	750	Pneumococcal conjugate vaccine GSK1024850A.+Paracetamol.+Infanrix hexa. (Synflorix I Group)	lycbxbunqh(sieiozkjvy) = zfbuqqglqf uyeuuboaoa (tlwjghjmjv, opuvrjthwl - odienhbhol) View more	-	18 Jan 2019
				Pneumococcal conjugate vaccine GSK1024850A.+Infanrix hexa. (Synflorix II Group)	lycbxbunqh(sieiozkjvy) = fosrnczrso uyeuuboaoa (tlwjghjmjv, ayoqrawnom - sgvqjsgooy) View more
NCT00390910 (CTgov)	Phase 3	Streptococcal Infections	286	Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group III)	xuepjqyyxr(slxdlxfqtn) = vevszhhcqq dohsebbncd (mqeixyulgr, cnjqggtufp - degcxaxoat) View more	-	17 Dec 2018
				Pneumococcal conjugate vaccine GSK1024850A+Infanrix hexa (Synflorix™ + Infanrix™ Hexa Group I)	gockfpaivn(lgsjakcist) = uteqjcbwsr mfnfojuwfs (xaatmsfkwz, vvsxryjmia - cjckkieabe) View more
NCT00370396 (CTgov)	Phase 3	Streptococcal Infections	1,200	Synflorix+Infanrix hexa (Synflorix-Synflorix Group)	txvvpefirm(cxwmbhbfph) = tnduglwkwh wxlonokher (ixahncjeoc, avzljcjgoh - otanwalfdy) View more	-	26 Nov 2018
				Infanrix hexa+Prevenar (Prevenar-Prevenar Group)	txvvpefirm(cxwmbhbfph) = ayedxgovye wxlonokher (ixahncjeoc, ijmdxuvbku - xzrflzmgdx) View more
NCT02096263 (CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Poliomyelitis	585	Hiberix+Infanrix+Infanrix hexa+Rotarix+Prevnar13 (Infanrix Hexa Group)	zwtitetthi(klhkalubac) = gcvuffxqmc pwtjfxrlst (bobrmodzhc, wubwnocdup - luyysqhhyr) View more	-	01 Aug 2018
				ActHIB+Infanrix+Rotarix+Prevnar13+Pediarix (Pediarix Group)	zwtitetthi(klhkalubac) = ntpyhhevyi pwtjfxrlst (bobrmodzhc, wltjybllnr - kdpheahqkv) View more
NCT00432042 (V221-035, CTgov)	Phase 3	Diphtheria \| Hepatitis B \| Rubella \| Mumps \| Measles \| Haemophilus Infections \| Whooping Cough \| Tetanus \| Chickenpox \| Poliomyelitis	955	Infanrix® hexa	oozzvseuhr(cwiqcceiit) = wlfirbrhuv wzjutcehwf (kelnymkvap, llnpwwwvoj - ltbxhbyfpc) View more	-	19 Mar 2018