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Tedivax-Adult/ Td-Rix

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

Tedivax-Adult/ Td-Rix · 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 PertussisUnlock trial analytics

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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Frequently asked questions about Tedivax-Adult/ Td-Rix

What is Tedivax-Adult/Td-Rix used for?

Tedivax-Adult/Td-Rix is a vaccine used for diphtheria, tetanus, and pertussis. It is being developed by GSK plc (GSK) and is currently in Phase 3 clinical development. The vaccine is intended for adults aged 18 years and older.

What does Tedivax-Adult/Td-Rix target?

Tedivax-Adult/Td-Rix targets the bacterial toxins that cause diphtheria, tetanus, and pertussis (whooping cough). It is a reduced-antigen-content acellular pertussis vaccine combined with diphtheria and tetanus toxoids, designed to boost immunity in adults.

Who makes Tedivax-Adult/Td-Rix?

Tedivax-Adult/Td-Rix is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical trials for the prevention of diphtheria, tetanus, and pertussis.

What phase is Tedivax-Adult/Td-Rix in?

Tedivax-Adult/Td-Rix is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with 116 participants enrolled.

What clinical trials is Tedivax-Adult/Td-Rix in?

Tedivax-Adult/Td-Rix has one completed Phase 3 trial registered as NCT01262924, titled "Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine." The trial enrolled 116 healthy adults aged 18 years and older and used an active-controlled design.

Is Tedivax-Adult/Td-Rix the same as Td-Rix?

Yes, Tedivax-Adult/Td-Rix is also known as Td-Rix. The vaccine is being developed by GSK plc for the prevention of diphtheria, tetanus, and pertussis in adults, and it is currently in Phase 3 clinical development.