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PriorixTM

Phase 3

Measles | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 8, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment475

FDA Designations

No designations recorded

Clinical trial landscape

PriorixTM · 1 trial · 4 indications

Phase 3 1
NCT00751348Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136Measles
COMPLETED475 Analytics
PHASE3COMPLETED
Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
MeaslesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
At 42 days post-vaccination

Seroconversion was defined as the appearance of antibodies \[i.e. titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative \[i.e. titer below (\<) cut-off value\] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.

Secondary Endpoints

Antibody Concentrations Against Measles
At 42-days post-vaccination
Antibody Concentrations Against Mumps
At 42-days post-vaccination
Antibody Concentrations Against Rubella
At 42-days post-vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
PRIORIX-TETRA GROUPEXPERIMENTALHealthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
PRIORIX + VARILRIX GROUPACTIVE_COMPARATORHealthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Interventions

NameTypeDescription
PriorixTMBIOLOGICALSubcutaneous administration in left upper arm
VarilrixTMBIOLOGICALSubcutaneous administration in right upper arm
Priorix-Tetra®BIOLOGICALSubcutaneous injection in left upper arm
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Eligibility Criteria

Age Range11 Months to 24 Months
SexALL
Healthy VolunteersYes
Study Sites13

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including 11 and 24 months of age, at the time of the vaccination. * Written informed ...

Countries:South Korea
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Frequently asked questions about PriorixTM

What is Priorix used for?

Priorix is a vaccine used for measles, as well as mumps, rubella, and varicella, based on its clinical trial in these conditions. It is being developed by GSK plc for the prevention of these infectious diseases.

Who makes Priorix?

Priorix is developed by GSK plc, a biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical development of this vaccine for measles and related infectious diseases.

What phase is Priorix in?

Priorix is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an active-controlled study. The vaccine is investigational and not yet approved for use.

What clinical trials is Priorix in?

Priorix has one completed Phase 3 clinical trial, NCT00751348, which studied the immunogenicity and safety of a combined measles-mumps-rubella-varicella vaccine. The trial enrolled 475 participants in South Korea, including healthy volunteers aged 11 months and older.

Is Priorix a monoclonal antibody?

No, Priorix is a vaccine, not a monoclonal antibody. Although the modality is listed as a monoclonal antibody in the data, the clinical trial description indicates it is a combined measles-mumps-rubella-varicella vaccine, which is a different type of biologic.