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GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment550

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine · 1 trial · 3 indications

Phase 3 1
NCT01267058Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy AdultsDiphtheria
COMPLETED550 Analytics
PHASE3COMPLETED
Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults
Diphtheria
NCT01267058550
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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 to 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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