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Pneumococcal vaccine GSK2830930A

Phase 1

Infections, Streptococcal | Monoclonal antibody | Other |GSK plc|Last Updated: Feb 10, 2021

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 Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01485406Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in ToddlersPHASE1 COMPLETED 61 — — Dec 12, 2011Mar 15, 2012Feb 10, 20214 Germany
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Study Endpoints
Primary Endpoints
Occurrence of each grade 3 solicited adverse event with relationship to vaccination
Within 7 days (Day 0-Day 6) after vaccination
Occurrence of grade 3 unsolicited adverse events with relationship to vaccination
Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse events with relationship to vaccination
During the entire study (from Month 0 up to Month 1)
Secondary Endpoints
Occurrence of each solicited adverse event
Within 7 days (Day 0-Day 6) after vaccination
Occurrence of each unsolicited adverse event
Within 31 days (Day 0-Day 30) after vaccination
Occurrence of serious adverse event
During the entire study (from Month 0 up to Month 1)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Pn GroupEXPERIMENTALToddlers 12-23 months of age receiving GSK2830930A vaccine.
Control GroupACTIVE_COMPARATORToddlers 12-23 months of age receiving Synflorix.
Interventions
NameTypeDescription
Pneumococcal vaccine GSK2830930ABIOLOGICAL1 dose administered intramuscularly
Synflorix™BIOLOGICAL1 dose administered intramuscularly
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Eligibility Criteria
Age Range12 Months — 23 Months
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol. * A male or female between, and including 12 to 23 months of age at the time of vaccination. * Written informed co...

Countries:Germany
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