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11-valent pneumococcal vaccine GSK513026

Phase 1

Infections, Streptococcal | Monoclonal antibody | Other |GSK plc|Last Updated: May 8, 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_CONTROLLED
Total Trials1
Total Enrollment335
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00327665Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly PopulationPHASE1 COMPLETED 335 — — May 1, 2006Jan 8, 2007May 8, 20173 Belgium, Finland +1
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Study Endpoints
Primary Endpoints
Occurrence, intensity and relationship to vaccination 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 31-day follow up period after each vaccine dose.
Occurrence and relationship to vaccination of all serious adverse events (SAEs).
Throughout the study period.
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11
1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.
One month after the first vaccine dose.
Secondary Endpoints
Haematological and biochemical levels within or outside the normal ranges in all groups.
At Months 0, 1, 3, 4 and 12.
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.
At Months 0, 1, 3, 4 and 12.
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.
At Months 0, 1, 3, 4 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
Group DACTIVE_COMPARATOR -
Group EACTIVE_COMPARATOR -
Interventions
NameTypeDescription
11-valent pneumococcal vaccine GSK513026BIOLOGICALTwo-dose intramuscular injection. Each group receiving one of the 3 formulations
Pneumo 23™BIOLOGICALSingle-dose intramuscular injection.
PlaceboBIOLOGICAL1 intramuscular injection.
10-valent pneumococcal vaccine GSK513026BIOLOGICALTwo-dose intramuscular injection
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Eligibility Criteria
Age Range65 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * A male or female between 65 and 85 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. Exclusion Criteria: * Pre...

Countries:BelgiumFinlandSweden
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