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10 valent pneumococcal conjugate

Phase 3

Infections, Streptococcal | Monoclonal antibody | Other |GSK plc|Last Updated: Oct 28, 2016

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment390
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00370227Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate VaccinePHASE3 COMPLETED 390Oct 1, 2006Mar 1, 2007Oct 28, 20168 Finland
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Study Endpoints
Primary Endpoints
Post vacc: rectal fever >39°C
Secondary Endpoints
AEs/ SAEs (42 days/up to 6 mo post last vacc); prior & 42-56 days post vacc: immune response to pneumo & MMRV vaccines antigens.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
10 valent pneumococcal conjugate (vaccine)BIOLOGICAL -
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Eligibility Criteria
Age Range12 Months — 14 Months
SexALL
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * a healthy male or female, 12-14 months of age at the time of first vaccination, who received at least one dose of pneumococcal conjugate vaccine during study 105553 and with written informed consent obtained from the parent/guardian of the subject. Exclusion Criteria: * use ...

Countries:Finland
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