Delving into the Latest Updates on Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Live attenuated vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

Polio Sabin

Target-

Action-

Mechanism-

Therapeutic Areas

Infectious DiseasesNervous System DiseasesOther Diseases

Active Indication

Poliomyelitis

Inactive Indication

Streptococcal Infections

Originator Organization

GSK Plc

Active Organization

GSK Plc

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol. After this cessation of OPV2, stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future outbreak. However, there will be a risk of cVDPV2 from Sabin 2 in settings of low population immunity. Research is ongoing to develop vaccines that are genetically more stable than the currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability endpoints of mOPV2 in children aged 1 to 5 years and in infants approximately 18 weeks of aged vaccinated with bOPV-/IPV for better understanding of the stockpile use of this vaccine, and for comparison with any potential new polio vaccine with a type 2 component in the future.

Start Date01 Oct 2015

Sponsor / Collaborator

Fidec SAS

[+1]

NCT01345240

/ CompletedPhase 3

Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

Start Date17 Nov 2011

Sponsor / Collaborator

GSK Plc

NCT01175083

/ CompletedPhase 3

Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age

The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.

Start Date01 Jun 2011

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

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18

Literatures (Medical) associated with Trivalent Oral Poliomyelitis vaccine(GlaxoSmithKline Plc)

06 Jul 2019·Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine]

[Analysis on the characteristics of suspected vaccine-related deaths in Fujian Province, 2012-2017].

Article

Author: Xiao, J X ; Lin, Z Q ; Wu, R H ; Zhou, Y

Objective: To analyze the characterisitics of the death cases suspected to be related to vaccination in Fujian Province from 2012 to 2017. Methods: A total of 33 death cases information which was suspected to be related to the vaccinations from 2012 to 2017 were extracted from Chinese Adverse Events Following Immunization Information System (AEFI). The autopsy reports and the conclusions made by AEFI investigation diagnosis expert committee were collected at the same time. The inoculation data were obtained through the Fujian province Immunization Program Information System. The AEFI incidence, rare vaccine reaction incidences and mortality rates following immunization were figured out to analyze the characterisitics of the death cases associated with vaccination. Results: The age of deuths cases was from 26 days to 52 months. Among 33 cases, 23 were males, and 8 were due to vaccine-related reaction, and the others were due to coincidental events. The number of rare vaccine reaction cases from 2012 to 2017 were 2,3,6,8,7 and 7, respectively. The highest AEFI incidence was measles and rubella combined attenuated live vaccine [38.88 (95%CI: 36.85-40.91)/100 000 dose], and the lowest was trivalent oral poliomyelitis attenuated live vaccine [2.01 (95%CI: 1.73-2.30)/100 000 dose]. The highest rare vaccine reaction incidence was measles and rubella combined attenuated live vaccine [15.04 (95%CI: 13.78-16.30)/100 000 dose], and the lowest was trivalent oral poliomyelitis attenuated live vaccine [0.38 (95%CI: 0.25-0.50)/100 000]. The highest mortality rate was inactivated poliomyelitis vaccine [0.26 (95%CI: 0.04-0.54)/100 000 doses], and the lowest mortality rate was measles, mumps and rubella combined attenuated live vaccine [0.01 (95%CI: 0.00-0.08)/100 000 doses]. The Spearman correlation analysis showed that there were correlations between AEFI incidence and rare vaccine reaction incidence (r=0.64, P=0.048), there were no correlations between AEFI incidence and mortality rate (r=-0.34, P=0.329), and there were no correlations between rare vaccine reaction incidence and mortality rate (r=-0.25, P=0.484). Conclusion: Neither AEFI incidence nor rare vaccine reaction incidence was correlation with mortality rate. The main causes of death following vaccination were coincidental events.

01 Jul 2001·Journal of Virology

Genomic Features of Intertypic Recombinant Sabin Poliovirus Strains Excreted by Primary Vaccinees

Article

Author: Guillot, Sophie ; Combiescu, Mariana ; Cuervo, Nancy Stella ; Caro, Valérie ; Seghier, Mohamed ; Romanenkova, Natalia ; Delpeyroux, Francis ; Aubert-Combiescu, André ; Crainic, Radu

ABSTRACTThe trivalent oral poliomyelitis vaccine (OPV) contains three different poliovirus serotypes. It use therefore creates particularly favorable conditions for mixed infection of gut cells, and indeed intertypic vaccine-derived recombinants (VdRec) have been frequently found in patients with vaccine-associated paralytic poliomyelitis. Nevertheless, there have not been extensive searches for VdRec in healthy vaccinees following immunization with OPV. To determine the incidence of VdRec and their excretion kinetics in primary vaccinees, and to establish the general genomic features of the corresponding recombinant genomes, we characterized poliovirus isolates excreted by vaccinees following primary immunization with OPV. Isolates were collected from 67 children 2 to 60 days following vaccination. Recombinant strains were identified by multiple restriction fragment length polymorphism assays. The localization of junction sites in recombinant genomes was also determined. VdRec excreted by vaccinees were first detected 2 to 4 days after vaccination. The highest rate of recombinants was on day 14. The frequency of VdRec depends strongly on the serotype of the analyzed isolates (2, 53, and 79% of recombinant strains in the last-excreted type 1, 2, and 3 isolates, respectively). Particular associations of genomic segments were preferred in the recombinant genomes, and recombination junctions were found in the genomic region encoding the nonstructural proteins. Recombination junctions generally clustered in particular subgenomic regions that were dependent on the serotype of the isolate and/or on the associations of genomic segments in recombinants. Thus, VdRec are frequently excreted by vaccinees, and the poliovirus replication machinery requirements or selection factors appear to act in vivo to shape the features of the recombinant genomes.

01 Jan 1995·Advances in experimental medicine and biologyQ4 · MEDICINE

Nasopharyngeal and systemic humoral responses induced by trivalent attenuated poliomyelitis vaccine in newborns.

Q4 · MEDICINE

Article

Author: Berber, A ; Acosta-Altamirano, G ; Leal, E R ; Casasola, J ; Valdivia-Gallardo, P A ; Padilla-Ramos, J C

100 Deals associated with Trivalent Oral Poliomyelitis 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
Poliomyelitis	-	GSK Plc	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Streptococcal Infections	Preclinical	Nigeria	GSK Plc	18 Jun 2008
Streptococcal Infections	Preclinical	Mali	GSK Plc	18 Jun 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01175083 (CTgov)	Phase 3	Streptococcal Infections	300	GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6S Group)	utrutpsumk(citbgfrnme) = limrtrlqky hvlopibxty (xgjszkyglo, bihdzjafka - lkzhgnyyco) View more	-	06 Jun 2019
				GSK1024850A+Tritanrix-HepB/Hib+Polio Sabin (Tritanrix-HepB/Hib+Polio Sabin <6NS Group)	utrutpsumk(citbgfrnme) = qvgzmmauyn hvlopibxty (xgjszkyglo, ujyqzzxxjc - mdvcvjkewz) View more
NCT00547248 (CTgov)	Phase 3	Streptococcal Infections	756	Synflorix+Tritanrix-HepB+Hiberix+Polio Sabin (Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group)	(hafunbhugp) = jjnnnpzqiv uvwlhnaoyc (nnvayitdbe, eqizcsrwbd - cngrxyiyqp) View more	-	14 Jan 2019
				Tritanrix-HepB+Hiberix+Polio Sabin+Prevenar (Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group)	(hafunbhugp) = ianjozfchu uvwlhnaoyc (nnvayitdbe, periigbhqu - omavtjmubf) View more
NCT01098474 (CTgov)	Phase 2	Tuberculosis	301	GSK's investigational vaccine 692342 (SB692342 2 Dose Group)	jfivqyzcxj(cxbuqggwfx) = shkudlzdzw jpmtrwzwmg (ybqdzzvgss, nduvzyhjsz - digwxpwhac) View more	-	27 Nov 2018
				GSK's investigational vaccine 692342 (SB692342 1 Dose Group)	jfivqyzcxj(cxbuqggwfx) = pwhzynqlvp jpmtrwzwmg (ybqdzzvgss, aislcandze - sawvvkpvbm) View more
NCT00678301 (CTgov)	Phase 3	Streptococcal Infections	365	GSK Biologicals' Synflorix™+GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Synflorix™ + Zilbrix™ Hib + Polio Sabin™)	frpxdfdcio(iehrhubbgw) = sjfllfwbut ilujouvbwu (qpxmztnczc, pwwnqsicdk - emmmysxmgs) View more	-	27 Oct 2017
				GSK Biologicals' Polio Sabin™+GSK Biologicals' Zilbrix™ Hib (Zilbrix™ Hib + Polio Sabin™)	frpxdfdcio(iehrhubbgw) = lggnzrwebb ilujouvbwu (qpxmztnczc, igbcrkohnd - irjquqqutf) View more
NCT01231503 (CTgov)	Phase 2	Malaria	480	BCG+Tritanrix HepB Hib+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-14 Group)	fpynyynsjr(kyjeozupmq) = nbigyylxdj hwdclayptq (ohsuoboerv, fgajhfksea - fewzazfpmg) View more	-	20 May 2015
				BCG+Tritanrix HepB Hib+OPV+GSK Biological's Investigational Malaria Vaccine 257049 (RTS,S Neo-10-26 Group)	fpynyynsjr(kyjeozupmq) = hbseleumex hwdclayptq (ohsuoboerv, ohlmrpmxse - lmbmkcbryi) View more
NCT00436007 (CTgov)	Phase 2	Yellow Fever \| Malaria \| Measles	511	Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 1 Group)	xueglozkex(mxkagpsfej) = csiajzrqxh zzgzogcevt (djotyefcbm, qdnioucqhf - elopmfncoh) View more	-	27 May 2013
				Rouvax™+Tritanrix+Hiberix+Stamaril™+Polio Sabin™+GSK 257049 (GSK 257049 2 Group)	xueglozkex(mxkagpsfej) = revivoptlz zzgzogcevt (djotyefcbm, llrlcseajh - zwwugrqxey) View more
NCT00263666 (CTgov)	Phase 2	Rotavirus Infections \| HIV Infections	100	Tritanrix-HB+Hib+Rotarix+Polio Sabin (Rotarix Group)	ufvkdbhabq(ytkyolnzav) = lodkckpcoz qtzqudeexv (rslrjdthkk, snmxehkemx - nhmduxfxoh) View more	-	13 Mar 2009
				Placebo+Tritanrix-HB+Hib+Polio Sabin (Placebo Group)	ufvkdbhabq(ytkyolnzav) = pqgrwisouz qtzqudeexv (rslrjdthkk, fphjjbrqmz - rkdeodsmwx) View more