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Pneumococcal vaccine GSK2189241A

Phase 1

Infections, Streptococcal | Monoclonal antibody | Other |GSK plc|Last Updated: May 10, 2017

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment168
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00756067Evaluation of Pneumococcal Vaccine Formulations in ElderlyPHASE1 COMPLETED 168 — — Sep 19, 2008May 28, 2009May 10, 20173 Sweden
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Study Endpoints
Primary Endpoints
Occurrence of any vaccine related and grade 3 solicited local and general adverse events
During a 7-day follow up period after each vaccine dose
Occurrence of any vaccine related and grade 3 unsolicited adverse events
During a 31-day follow up period after each vaccine dose
Occurrence of any vaccine related serious adverse events (SAE)
From dose 1 to study conclusion
Occurrence of any grade 3 laboratory abnormalities
At 1 and 7 days after each vaccine dose
Secondary Endpoints
Occurrence of any solicited local and general adverse events
During a 7-day follow up period after each vaccine dose
Occurrence of any unsolicited adverse events
During a 31-day follow up period after each vaccine dose
Occurrence of any laboratory abnormalities
At 1 and 7 days after each vaccine dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Formulation 1EXPERIMENTAL -
Formulation 2EXPERIMENTAL -
Formulation 3EXPERIMENTAL -
Formulation 4EXPERIMENTAL -
Formulation 5EXPERIMENTAL -
Formulation 6EXPERIMENTAL -
23 valent pneumococcal vaccineACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Pneumococcal vaccine GSK2189241ABIOLOGICALTwo doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Pneumo 23™BIOLOGICALOne dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.
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Eligibility Criteria
Age Range65 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * Male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health. * Written informed...

Countries:Sweden
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