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PhtD vaccine with/without adjuvant

Phase 1

Pneumococcal Disease | Monoclonal antibody | Other |GSK plc|Last Updated: Jan 14, 2013

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment150
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01767402Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy AdultsPHASE1 COMPLETED 150 — — Oct 1, 2003Nov 1, 2004Jan 14, 20131 Belgium
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Study Endpoints
Primary Endpoints
Occurrence, intensity and relationship of any solicited local and general signs and symptoms
During a 7-day follow up period (i.e. Days 0-6) after each vaccine dose
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
During a 30-day follow up period (i.e. Days 0-29) after each vaccine dose
Occurrence of all serious adverse events (SAEs)
During the 12 months of the study
Anti-PhtD antibody concentration in all vaccine groups (measured by ELISA)
One month after the first injection
Secondary Endpoints
Number and percentage of subjects with normal or abnormal values, for biochemical assessments and for hematological analysis
At month 0, 1, 3 and 12
Anti-PhtD antibody concentration in all groups (measured by ELISA)
At 12 months after the first vaccination
Anti-PhtD antibody avidity (measured by ELISA)
At month 0, 1, 3 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PhtD Group 1EXPERIMENTALSubjects will receive PhtD vaccine formulation 1 without any adjuvant.
PhtD Group 2EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 2.
PhtD Group 3EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 3.
PhtD Group 4EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 4.
PhtD Group 5EXPERIMENTALSubjects will receive adjuvanted PhtD vaccine formulation 5.
23 PPV GroupACTIVE_COMPARATORSubjects will receive the Pneumovax 23TM vaccine and NaCl.
Interventions
NameTypeDescription
PhtD vaccine with/without adjuvantBIOLOGICALTwo doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
Pneumovax 23TMBIOLOGICALOne dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.
NaClBIOLOGICALOne dose administered intramuscularly in the deltoid region of the right arm at month 2.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 18 and 45 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Fr...

Countries:Belgium
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