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PriorixTetra

Phase 3

Rubella | Monoclonal antibody | Other |GSK plc|Last Updated: Aug 17, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment716
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01506193Immunogenicity and Safety Study of PriorixTetra™ When Co-administered With Conjugated MenC Vaccine in Healthy ChildrenPHASE3 COMPLETED 716 — — Feb 6, 2012Mar 31, 2014Aug 17, 201813 Italy
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Study Endpoints
Primary Endpoints
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
At 42 days after vaccination

Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.

Number of Seroprotected Subjects for rSBA-MenC Antibodies
At 42 days after vaccination

Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.

Secondary Endpoints
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting Fever Per Half Degree
During the 43-day (Days 0-42) post-vaccination period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AACTIVE_COMPARATORSubjects in this arm will receive MMRV vaccine at Visit 1 (Day 0) and MenC vaccine at Visit 2 (Days 35-49).
Group BEXPERIMENTALSubjects will receive MMRV vaccine and MenC vaccine at Visit 1 (Day 0).
Group CACTIVE_COMPARATORSubjects will receive Men C vaccine at Visit 1 (Day 0) and MMRV vaccine at Visit 2 (Day 35-49).
Interventions
NameTypeDescription
PriorixTetra™BIOLOGICALOne dose administered subcutaneously
MeningitecBIOLOGICALOne dose administered intramuscularly
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Eligibility Criteria
Age Range13 Months — 15 Months
SexALL
Healthy VolunteersYes
Study Sites13

Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol. * A male or female between, and including, 13 and 15 months of age at the time of the first vaccination. * Written informed...

Countries:Italy
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