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pneumococcal vaccine

Phase 2

Prophylactic Pneumococcal Diseases | Monoclonal antibody | Other |GSK plc|Last Updated: Oct 13, 2008

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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00327522Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.PHASE2 COMPLETED 10 — — Jun 1, 2006 -Oct 13, 20081 Belgium
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Study Endpoints
Primary Endpoints
Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;
Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Interventions
NameTypeDescription
pneumococcal vaccineBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy male or female between 18 and 40 years of age * 23-valent pneumococcal polysaccharide vaccine naive adults. Exclusion Criteria: * Previous vaccination against Streptococcus pneumoniae. * History of pneumonia within 3 years prior to the first vaccination * Any confirm...

Countries:Belgium
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