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GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine

Phase 3

Diphteria, Tetanus and Pertussis | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Dec 17, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine · 1 trial · 1 indication

Phase 3 1
NCT01262924Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis VaccineDiphteria, Tetanus and Pertussis
COMPLETED116 Analytics
PHASE3COMPLETED
Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine
Diphteria, Tetanus and Pertussis
NCT01262924116
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Study Endpoints

Primary Endpoints

Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™)
One month after the booster dose (Month 1)

Secondary Endpoints

Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™)
One month after the booster dose (Month 1)
Occurrence of solicited local adverse experiences
During the 15-day (Day 0-14) follow-up period after vaccination
Occurrence of solicited general adverse experiences
During the 15-day (Day 0-14) follow-up period after vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALdTPa vaccine
Group BEXPERIMENTALPa vaccine
Group CACTIVE_COMPARATORTedivax-Adult™/ Td-Rix™

Interventions

NameTypeDescription
GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccineBIOLOGICALIntramuscular, single dose
GSK Biologicals' reduced-antigen-content acellular pertussis vaccineBIOLOGICALIntramuscular, single dose
Tedivax-Adult™/ Td-Rix™BIOLOGICALIntramuscular, single dose or 2 doses (in the annex phase)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes

Inclusion Criteria: * A male or female aged ≥18 years at the time of vaccination * Free of obvious health problems as established by medical history and clinical examination before entering into the study * Written informed consent obtained from the subject * If the subject is female, she must be o...

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