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Pneumovax 23

Phase 2

Streptococcus Pneumoniae Vaccines | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Apr 15, 2013

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
UNCONTROLLED
Total Trials1
Total Enrollment1,198
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00307008Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.PHASE2 COMPLETED 1,198 — — Oct 1, 2003Feb 1, 2005Apr 15, 20135 Sweden
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Study Endpoints
Primary Endpoints
Response rate to 11 vaccine serotypes
One month post vaccination
Secondary Endpoints
Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes
At all time points
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects
At Day 0 and Day 30.
The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to
One month post vaccination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Interventions
NameTypeDescription
Pneumovax 23™BIOLOGICALSingle dose intramuscular injection
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Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites5

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. Exclusion criteria * Use of any investigational or non-registe...

Countries:Sweden
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