Delving into the Latest Updates on MMR-varicella zoster virus vaccine(GlaxoSmithKline Plc) with Synapse

Overview

Basic Info

Drug Type

Combination vaccine, Live attenuated vaccine, Prophylactic vaccine

Synonyms

MMR-varicella zoster virus vaccine, Priorix-Tetra, PriorixTetra

+ [1]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesMouth and Tooth DiseasesOther Diseases

Active Indication

MeaslesMumpsRubella+ [1]

Inactive Indication

ChickenpoxHepatitis A

Originator Organization

GSK Plc

Active Organization

GSK Plc

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

Germany (01 Jul 2006),

MeaslesMumpsRubella+ [1]

Regulation-

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The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.

Start Date06 Feb 2012

Sponsor / Collaborator

GSK Plc

NCT00969436

/ CompletedPhase 3

A Phase IIIb, Open, Randomised, Multicentre, Primary Study in Healthy Children, to Establish the Non-inferiority of GlaxoSmithKline (GSK) Biologicals' MeMuRu-OKA Vaccine (Administered at 9 and 15 Months of Age) Versus Priorix™ (9 Months of Age) and Priorix™ Co-administered With Varilrix™ at 15 Months of Age (Comparator) and Also to Evaluate the Non-inferiority of Priorix™ (9 Months of Age) and MeMuRu-OKA Vaccine (15 Months of Age) Versus the Comparator, All Administered Subcutaneously as Two-dose Primary Vaccination Course

The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.

Start Date09 Nov 2009

Sponsor / Collaborator

GSK Plc

NCT00892775

/ CompletedPhase 2

Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds

This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator.
A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.

Start Date03 Jun 2009

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with MMR-varicella zoster virus vaccine(GlaxoSmithKline Plc)

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100 Translational Medicine associated with MMR-varicella zoster virus vaccine(GlaxoSmithKline Plc)

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100 Patents (Medical) associated with MMR-varicella zoster virus vaccine(GlaxoSmithKline Plc)

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18

Literatures (Medical) associated with MMR-varicella zoster virus vaccine(GlaxoSmithKline Plc)

01 Mar 2024·Vaccine

Effectiveness of the combined MMRV Priorix-Tetra™ vaccine against varicella in a large Italian region: A case-control study

Article

Author: Martinelli, Domenico ; Fortunato, Francesca ; Iannelli, Giuseppina ; Meola, Martina ; Musco, Angelo ; Luigi Lopalco, Pier

Priorix-Tetra™ (MMRV GlaxoSmithKline Biologicals' vaccine) was developed based on the existing measles-mumps-rubella and varicella vaccines. In this study, we aimed to estimate the effectiveness of the combined measles-mumps-rubella-varicella Priorix-Tetra™ vaccine against varicella in real-world conditions. We conducted a post-marketing retrospective case-control study in the Apulia region of Italy in children aged 1-9 years born between January 1, 2008 and December 31, 2016. We assessed the effectiveness against varicella of all grades of severity (including hospitalisation) and against hospitalisation for varicella of a single and two doses of Priorix-Tetra™. Moreover, we also assessed effectiveness of monovalent varicella (monovalent-V) vaccine and any varicella vaccines. Vaccine effectiveness was calculated as (1-OR) x 100. We introduced demographic variables in the model to adjust Vaccine effectiveness (aVE) by potential confounders (sex and year of birth). We recorded 625 varicella cases and matched them with 1,875 controls. Among 625 cases, 198 had received a single MMRV dose, 10 two MMRV doses, 46 a single monovalent-V dose, none two monovalent-V doses; four a monovalent-V as first dose and MMRV as second dose, and one a MMRV as first dose and monovalent-V as second dose; 366 cases were not vaccinated. The aVE against varicella of all grades of severity was 77.0% and 93.0% after a single dose and after two doses of MMRV, respectively. The aVE against varicella of all grades was 72.0% after a single dose of monovalent-V vaccine. The aVE against varicella of all grades of severity was 76.0% after a single dose and 94.0% after two doses of any varicella vaccine. The aVE against varicella hospitalisation was 96% after a single dose of any varicella vaccine. Priorix-Tetra™ showed to be an effective vaccine and the two-dose schedule should be recommended to optimise immunisation programmes. A single dose was able to provide protection against varicella hospitalisation.

03 Oct 2022·Current Medical Research and Opinion

Relative efficacy of varicella vaccines: network meta-analysis of randomized controlled trials

Review

Author: Sharma, Akanksha ; Pawaskar, Manjiri ; Siddiqui, Mohd Kashif ; Takyar, Jitender ; Fergie, Jaime

OBJECTIVEAlthough varicella vaccination is highly effective, no head-to-head randomized controlled trials (RCTs) have compared the efficacy of different vaccine formulations. This study assessed the relative efficacy of different varicella vaccines using network meta-analysis (NMA).METHODSWe estimated the relative efficacies of varicella vaccines and dosing regimens from RCTs using Bayesian NMA. Modeling-based time-series NMA (MBNMA) was performed, accounting for differences in time since vaccination, to extrapolate long-term vaccine efficacy (VE).RESULTSEight RCTs were included based on systematic review of biomedical databases. Efficacy data were reported for four varicella-containing vaccines: Varivax (V-MSD, one and two dose), Varilrix (V-GSK, one dose), Priorix-Tetra (MMRV-GSK, one dose), and Sinovac (V-Sinovac, one dose). All varicella vaccines were effective versus no vaccination. Two-dose V-MSD (98.29%, 95% credible interval [CrI] 96.08-99.23) showed significantly higher VE versus all one-dose varicella-containing vaccines, but no significant difference versus two-dose MMRV-GSK (95.19%, 95% CrI 90.3-97.63). Two-dose MMRV-GSK showed higher VE than one-dose V-GSK (66.47%; 95% CrI 43.02-79.43), but no significant differences in VE versus one-dose V-MSD or one-dose V-Sinovac. In one-dose comparisons, V-MSD showed significantly higher VE (93.09%, 95% CrI 89.13-95.96) than V-GSK, but no significant difference versus V-Sinovac (89.22%; 95% CrI 67.1-96.5). MBNMA indicated that protection against varicella was sustained without waning over the 10 year follow-up.CONCLUSIONSOur study reported higher VE for two-dose V-MSD and MMRV-GSK. Among one-dose formulations, one-dose V-MSD was more efficacious than one-dose V-GSK. Policymakers should take into consideration differences in VE when implementing one- versus two-dose strategies in universal vaccination programs.

01 Aug 2019·VaccineQ3 · MEDICINE

Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: A 10-year follow-up

Q3 · MEDICINE

Article

Author: Di Paolo, Emmanuel ; Povey, Michael ; Carryn, Stephane ; Feyssaguet, Muriel

Measles and mumps outbreaks still occur in countries that have successfully implemented universal routine immunization programs. Measles outbreaks are mostly associated to absent or incomplete vaccination, whereas for mumps outbreaks the combined effects of waning of immunity and circulating new strains are incriminated. It is therefore increasingly useful to characterize the long-lasting immunity induced by measles-, mumps, and rubella (MMR)-containing vaccines. In this 10-year study, 1887 healthy children aged 12-22 months, randomized to receive 1 or 2 doses of MMR-containing vaccines (Priorix or Priorix-Tetra; GSK), were included in an antibody persistence analysis. A total of 364 children in the 1-dose group received a second dose out of study according to their local vaccination schedule between Years 4 and 10 post-dose 1, and were included in a separate post-hoc analysis to evaluate the effect of the second dose when given later. Anti-measles, -mumps and -rubella antibody titers were measured by commercial ELISA kits (Enzygnost, Siemens) after each vaccine dose and at Years 1, 2, 4, 6, 8 and 10 post-vaccination. Antibodies against measles and rubella declined moderately after vaccination but remained well above the seropositivity threshold after 10 years. The anti-measles antibody titers elicited by Priorix-Tetra remained about 2-fold higher throughout the study as compared with Priorix. A second dose of MMR vaccine later in life had a minor and transient effect on anti-measles and anti-rubella waning titers. In contrast, anti-mumps antibody levels remained relatively stable over the 10-year follow-up and a second dose of MMR vaccine, given anytime over the 10-year period, had a boosting effect on anti-mumps antibody titers and seropositivity rates. In conclusion, 1 or 2 doses of MMR-containing vaccines given to children in their second year of life induced antibody responses against measles, mumps and rubella viruses that persisted at least up to 10 years post-vaccination. Clinical trial registration number: NCT00226499.

100 Deals associated with MMR-varicella zoster virus vaccine(GlaxoSmithKline Plc)

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Measles	Germany	GSK Plc	01 Jul 2006
Mumps	Germany	GSK Plc	01 Jul 2006
Rubella	Germany	GSK Plc	01 Jul 2006
Varicella Zoster Virus Infection	Germany	GSK Plc	01 Jul 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chickenpox	Discovery	United States	GSK Plc	20 Nov 2007
Hepatitis A	Discovery	United States	GSK Plc	20 Nov 2007
Measles	Discovery	United States	GSK Plc	20 Nov 2007
Mumps	Discovery	United States	GSK Plc	20 Nov 2007
Rubella	Discovery	United States	GSK Plc	20 Nov 2007

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00474266 (CTgov)	Phase 3	Meningococcal Infections	1,000	Priorix-Tetra+Meningococcal vaccine GSK134612 (Nimenrix) (Nimenrix + Priorix-Tetra Group)	pqwqizpigg(glysoxrqxn) = invgjedgst crthpagysm (lvxxzentgj, peounlvdty - fkzoruxknr) View more	-	15 Dec 2017
				Priorix-Tetra+Meningococcal vaccine GSK134612 (Nimenrix) (Nimenrix Group)	pqwqizpigg(glysoxrqxn) = jptikmujhh crthpagysm (lvxxzentgj, adqzmwdyvm - zdxmlxusie) View more
NCT00892775 (CTgov)	Phase 2	Rubella \| Mumps \| Measles \| Chickenpox	501	GSK Biologicals' 208136, new formulation (Priorix-Tetra New WS Group)	eepywndbcp(rvetoshpnt) = aoepibuspi rowzplcmzm (hqfjdozlzg, chhhqdtses - kbeupdglvp) View more	-	09 Oct 2017
				Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) (Priorix-Tetra Current WS Group)	eepywndbcp(rvetoshpnt) = tytswxhtpp rowzplcmzm (hqfjdozlzg, qtbcklxfzp - xuiptseawh) View more
NCT00969436 (CTgov)	Phase 3	Rubella \| Mumps \| Measles \| Chickenpox	450	GSK Biological's investigational MMRV vaccine 208136 (Priorix-Tetra Group)	axcdzzkprb(ebmyehxxfs) = wdhgguzuyy kgvtfbffwt (xdzirlmrvl, rwrduwzrpk - kbtqasbdku) View more	-	25 Sep 2017
				GSK Biological's investigational MMRV vaccine 208136+Priorix™ (Priorix/ Priorix-Tetra Group)	axcdzzkprb(ebmyehxxfs) = ttountuzxv kgvtfbffwt (xdzirlmrvl, sjcaersigs - fyumgbnoyd) View more
NCT00751348 (CTgov)	Phase 3	Rubella \| Mumps \| Measles \| Chickenpox	475	Priorix-Tetra® (Priorix-Tetra Group)	dqribhyyxu(qvljvzgenv) = fpoatqmktu hqvwumiqcw (ayhddzegxe, pqucdaxbeg - odiaytuhxn) View more	-	24 Apr 2017
				VarilrixTM+PriorixTM (Priorix + Varilrix Group)	dqribhyyxu(qvljvzgenv) = ddjmurjwss hqvwumiqcw (ayhddzegxe, xvuiqbaggx - bpmpzpdamv) View more
NCT00578175 (CTgov)	Phase 2	Hepatitis A \| Rubella \| Mumps \| Measles \| Chickenpox	1,851	Prevnar+Priorix-Tetra+Havrix (Refrigerator-stored Priorix-Tetra Group)	txysxntfni(ajyqwuludy) = hxoczjesxj fmxgleejrg (carrlcezhf, exqbpwcccs - ynpuvoyxyn) View more	-	26 Aug 2010
				Prevnar+Priorix-Tetra+Havrix (Freezer-stored Priorix-Tetra Group)	txysxntfni(ajyqwuludy) = lfwivemumo fmxgleejrg (carrlcezhf, fhphaewoqn - ppdougqbdy) View more