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GSK Biologicals' acellular pertussis vaccine

Phase 3

Diphtheria | Monoclonal antibody | Other |GSK plc|Last Updated: Dec 24, 2010

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_CONTROLLED
Total Trials1
Total Enrollment550
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01267058Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy AdultsPHASE3 COMPLETED 550 — — Sep 1, 1997Feb 1, 1998Dec 24, 2010 - —
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Study Endpoints
Primary Endpoints
Occurrence of solicited local and general symptoms
Within the 15-day (Day 0 - Day 14) follow-up period after the first injection
Secondary Endpoints
Immunogenicity with respect to components of the study vaccines
One month after the first injection
Occurrence of solicited local symptoms and fever
Within the 15-day (Day 0 - Day 14) follow-up period after the second injection
Occurrence of general solicited symptoms to vaccination, other than fever
Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALSubjects will receive the combined diphtheria, tetanus, acellular pertussis vaccine
Group BACTIVE_COMPARATORSubjects will receive the acellular pertussis vaccine and one month later the combined diphtheria and tetanus vaccine
Group CACTIVE_COMPARATORSubjects will receive the combined diphtheria and tetanus vaccine and one month later the acellular pertussis vaccine
Interventions
NameTypeDescription
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccineBIOLOGICALIntramuscular, single dose
GSK Biologicals' acellular pertussis vaccineBIOLOGICALIntramuscular, single dose
Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccineBIOLOGICALIntramuscular, single dose
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * At least 18 years of age at the time of the vaccination * Written informed consent has been obtained Exclusion Criteria: * Evidence of confirmed pertussis disease within the previous 5 years * History of diphtheria or tetanus vaccination within the past 5 years Females must ...

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