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Pneumococcal vaccine GSK513026

Phase 2

Prophylaxis Invasive Pneumococcal Diseases and Pneumonia | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 30, 2019

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment146
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00307528Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly PopulationPHASE2 COMPLETED 146 — — Jan 20, 2004Mar 30, 2005Oct 30, 20191 Belgium
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Study Endpoints
Primary Endpoints
Occurrence, intensity and relationship of any solicited local and general signs and symptoms.
During a 7-day follow up period after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.
During a 30-day follow up period after each vaccine dose.
Occurrence of all serious adverse events (SAE).
During the entire study period.
Anti- PhtD antibody concentration
One month after the first injection
Anti-PhtD antibody concentration.
One month after 2 injections
Secondary Endpoints
Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.
At each scheduled time point (month 0, 1, 3, 12, 24 and 36).
Anti- PhtD antibody concentration.
At 12, 24 and 36 months after the first vaccination.
Anti-PhtD antibody avidity.
At month 0, 1 and 3.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AACTIVE_COMPARATOR -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DEXPERIMENTAL -
Group EEXPERIMENTAL -
Group FEXPERIMENTAL -
Interventions
NameTypeDescription
Pneumococcal vaccine GSK513026BIOLOGICALTwo-dose intramuscular injection. Five different formulations, each administered to one Group
Pneumovax 23™BIOLOGICALSingle dose intramuscular injection.
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria * Subjects who the investigator believes will comply with the requirements of the protocol * A male or female ≥ 65 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Free of obvious health problems as established by medical history...

Countries:Belgium
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