Delving into the Latest Updates on Pneumococcal vaccine recombinant(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Pneumococcal vaccine recombinant, S. pneumoniae adult vaccine, 2189242-A

+ [3]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesOtorhinolaryngologic Diseases

Active Indication-

Inactive Indication

Infection of earOtitis MediaStreptococcal Infections

Originator Organization

GSK Plc

Active Organization-

Inactive Organization

GSK Plc

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

Start Date21 May 2012

Sponsor / Collaborator

GSK Plc

NCT01262872

/ CompletedPhase 2

Impact of GSK Biologicals' 2189242A Vaccine on Nasopharyngeal Carriage, Safety and Immunogenicity When Co-administered With Routine EPI Vaccines in Infants Following Safety Assessment in Children Aged 2-4 Years in The Gambia

This study will assess the impact on nasopharyngeal carriage, safety and immunogenicity of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose vaccination course and co-administered with other routine paediatric vaccines in infants in The Gambia. Two formulations containing different doses of pneumococcal antigen and two different schedules will be tested in infants.

Start Date09 Feb 2011

Sponsor / Collaborator

GSK Plc

[+3]

NCT01204658

/ CompletedPhase 2

Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Start Date27 Sep 2010

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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100 Translational Medicine associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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98

Literatures (Medical) associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

01 Dec 2024·Vaccine: X

Immunogenicities of vaccines including the immunoglobulin M-degrading enzyme of Streptococcus suis, rIde , and protective efficacy against serotype 14 in piglets

Article

Author: Liedel, C ; Mayer, L ; Baums, C G ; Klose, K ; Rieckmann, K ; de Greeff, A

Streptococcus suis (S. suis) is a major porcine pathogen. Some strains have a substantial zoonotic potential such as serotype (cps) 14 as the second most important cps in human infections. To this date no licensed S. suis vaccine is available in Europe though subunit vaccines and bacterins have been examined by several scientific groups worldwide. Objectives of this study were to determine protective efficacy of rIde _Ssuis vaccination against intranasal S. suis cps14 challenge in conventional weaned piglets and to investigate additionally immunogenicity of rIde _Ssuis vaccination in cesarean-derived colostrum-deprived (CDCD) piglets. Immunization led to reduction of bacterial multiplicity in porcine blood and delayed onset of clinical signs of cps14 disease in conventional rIde _Ssuis -vaccinated piglets. However, significant differences were not recorded which might be related to comparable low anti-Ide _Ssuis antibody levels and insufficient neutralization of IgM protease activity in this animal experiment. In contrast, immunization of cesarean-derived colostrum-deprived piglets with rIde _Ssuis resulted in high α-rIde _Ssuis IgG antibody levels and a highly significant reduction of the survival factor of the cps14 challenge strain in porcine blood in vitro. In conclusion, the results of this study indicate bactericidal immunity against S. suis cps14 by Ide _Ssuis specific immunity.

01 Dec 2024·The Lancet regional health. Southeast Asia

Routine immunization against Streptococcus pneumoniae and Haemophilus influenzae type B and antibiotic consumption in India: a dynamic modeling analysis

Article

Author: Parameswaran, Giridara Gopal ; Gleason, Alec C ; Laxminarayan, Ramanan ; Klein, Eili ; Kumar, Chirag K ; Gleason, Alec C. ; Nandi, Arindam ; Summan, Amit ; Kumar, Chirag K.

Background:

Childhood vaccinations can reduce disease burden and associated antibiotic use, in turn reducing the risk of antimicrobial resistance (AMR). We retrospectively estimated the population-level reductions in antibiotic use in India following the introduction of vaccines against Streptococcus pneumoniae and Haemophilius influenzae type B in the national immunization program for children in the mid-2010s and projected future gains to 2028 if vaccination coverage were to be increased.

Methods:

Using IndiaSim, a dynamic agent-based microsimulation model (ABM) for India, we simulated the spread of Streptococcus pneumoniae and Haemophilius influenzae type B (Hib) among children to estimate reductions in antibiotic use under the scenarios of: (i) pneumococcal and Hib vaccine coverage levels equivalent to the national coverage of pentavalent diphtheria-pertussis-tetanus third dose (DPT3) compared to a baseline of no vaccination, and (ii) near-universal (90%) coverage of the vaccines compared to pre-COVID national DPT3-level coverage. Model parameters, including national DPT3 coverage rates, were based on data from the National Family Household Survey 2015-2016 and other published sources. We quantified reductions in antibiotic consumption nationally and by state and wealth quintiles.

Findings:

We estimate that coverage of S. pneumoniae and Hib vaccines at the same level as DPT3 in India would translate to a 61.4% [95% UI: 43.8-69.5] reduction in attributable antibiotic use compared to a baseline of zero vaccination coverage. Increases in childhood vaccination coverage between 2004 and 2016 have likely reduced attributable antibiotic demand by as much as 93.4% among the poorest quintile. Increasing vaccination coverage by an additional 11 percentage points from 2016 levels results in mortality and antibiotic use across wealth quintiles becoming increasingly similar (p < 0.05), reducing in health inquities. We project that near-universal vaccine coverage would further reduce inequities in antibiotic demand and may eliminate of outbreak-associated antibiotic use from S. pneumoniae and Hib.

Interpretation:

Though vaccination has a complex relationship with antibiotic use because both are modulated by socioeconomic factors, increasing vaccinations for S. pneumoniae and Hib may have a significant impact on reducing antibiotic use and improving health outcomes among the poorest individuals.

Funding:

The Bill & Melinda Gates Foundation (grant numbers OPP1158136 and OPP1190803).

18 Sep 2023·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring.

Article

Author: Kim, Jerome H ; Steer, Andrew C ; Asturias, Edwin J ; Excler, Jean-Louis ; Zühlke, Liesl ; Long, Raj ; Sriskandan, Shiranee ; Sun, Wellington ; McCulloch, Mignon ; Dale, James B ; Cavaleri, Marco ; Fulurija, Alma ; Ackland, James

Streptococcus pyogenes (Strep A) infections result in a vastly underestimated burden of acute and chronic disease globally. The Strep A Vaccine Global Consortium's (SAVAC's) mission is to accelerate the development of safe, effective, and affordable S. pyogenes vaccines. The safety of vaccine recipients is of paramount importance. A single S. pyogenes vaccine clinical trial conducted in the 1960s raised important safety concerns. A SAVAC Safety Working Group was established to review the safety assessment methodology and results of more recent early-phase clinical trials and to consider future challenges for vaccine safety assessments across all phases of vaccine development. No clinical or biological safety signals were detected in any of these early-phase trials in the modern era. Improvements in vaccine safety assessments need further consideration, particularly for pediatric clinical trials, large-scale efficacy trials, and preparation for post-marketing pharmacovigilance.

100 Deals associated with Pneumococcal vaccine recombinant(GlaxoSmithKline Plc)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Infection of ear	Phase 2	US	GSK Plc	21 May 2012
Otitis Media	Phase 2	US	GSK Plc	21 May 2012
Streptococcal Infections	Phase 2	BE	GSK Plc	18 May 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00985751 (CTgov)	Phase 2	Streptococcal Infections	257	Synflorix (Synflorix Group)	belgeptkqd(ynqgofjzil) = osculqctni bcupyryzxy (vewuzxowid, ymobtmprdc - lxatpcoxyp) View more	-	06 Oct 2017
				Synflorix+GSK 2189242A (Synflorix/GSK 2189242A Group)	belgeptkqd(ynqgofjzil) = gomejwkvig bcupyryzxy (vewuzxowid, rtqqucyxsm - kkzxwspryu)
NCT01545375 (CTgov)	Phase 2	Streptococcal Infections \| Infection of ear \| Otitis Media	1,806	Pneumococcal vaccine GSK2189242A+PedvaxHIB®+Prevnar 13® (dPly-PhtD Group)	icokqpokmz(gvjchbzgpt) = jxbntyuuvr jkujegixrx (dcescldyqt, jpofjdbgyl - evajifyxpd) View more	-	12 Sep 2017
				Placebo+PedvaxHIB®+Prevnar 13® (Control Group)	icokqpokmz(gvjchbzgpt) = ocszxomkxb jkujegixrx (dcescldyqt, uvewkienjx - frljpziien) View more
NCT00896064 (CTgov)	Phase 2	Streptococcal Infections	43	GSK2189242A (GSK2189242A Formulation 1 Group)	prscsbbcxn(lykudzgnow) = yvefgkjkip lirfuaecxo (imnantdcms, ehjzqkfyew - yifvcbdyhe) View more	-	19 Jul 2017
				GSK2189242A (GSK2189242A Formulation 2 Group)	prscsbbcxn(lykudzgnow) = bnpttidnfs lirfuaecxo (imnantdcms, rugmbywpua - kngntyjztp) View more
NCT01204658 (CTgov)	Phase 2	Streptococcal Infections	576	Pneumococcal vaccine GSK 2189242A (LD formulation 1)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-LD/Infanrix Hexa Group)	fjuypybjmw(kromxgqudc) = alpvgcfsce vwiplafebi (miqlbducji, cgqmfosjia - njtmcdcwic) View more	-	28 Sep 2016
				Pneumococcal vaccine GSK 2189242A (HD formulation 2)+Infanrix Hexa (DTPa-HBV-IPV/Hib) (10PP-HD/Infanrix Hexa Group)	fjuypybjmw(kromxgqudc) = hkwuuexopp vwiplafebi (miqlbducji, vpuymtjigc - tahiraursi) View more